Federal Bills on Drug Pricing in the 115th Congress
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BillTitleSponsorsIntroducedNumber of co-sponsorsNames of all co-sponsorsNames of Dems co-sponsorsNames of GOP co-sponsorsCommitteesLast actionSummaryMedicare price negotiationsExtends patent and other exclusiviitesReduces patent or other exclusivitiesCompulsory license of drug patentsPBM regulationEnhance entry of generic productsPay-for-delayTransparency of pricesTransparency of R&D costsPatentable subject matter, or inventive stepInjunctions, demages, enforcement of patentsPTAB/IPRREMSImport drugsPrice spikesParallel tradePrize fund/MER/Delinkage
AMR incentives
Federally funded research and development
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H.R.242Medicare Prescription Drug Price Negotiation Act of 2017Rep. Welch, Peter [D-VT-At Large]01/04/201743
Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Cummings, Elijah E. [D-MD-7]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Lipinski, Daniel [D-IL-3]*, Rep. McCollum, Betty [D-MN-4]*, Rep. Castor, Kathy [D-FL-14]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Lynch, Stephen F. [D-MA-8]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Lujan Grisham, Michelle [D-NM-1]*, Rep. Cartwright, Matt [D-PA-17]*, Rep. Deutch, Theodore E. [D-FL-22], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Raskin, Jamie [D-MD-8], Rep. Loebsack, David [D-IA-2], Rep. Huffman, Jared [D-CA-2], Rep. Gabbard, Tulsi [D-HI-2], Rep. Blumenauer, Earl [D-OR-3], Rep. Visclosky, Peter J. [D-IN-1], Rep. Sherman, Brad [D-CA-30], Rep. Pingree, Chellie [D-ME-1], Rep. DeFazio, Peter A. [D-OR-4],Rep. Sarbanes, John P. [D-MD-3], Rep. Suozzi, Thomas R. [D-NY-3], Rep. Lofgren, Zoe [D-CA-19], Rep. Garamendi, John [D-CA-3], Rep. Maloney, Sean Patrick [D-NY-18], Rep. Langevin, James R. [D-RI-2], Rep. Rooney, Francis [R-FL-19], Rep. Gallego, Ruben [D-AZ-7], Rep. Takano, Mark [D-CA-41], Rep. Rush, Bobby L. [D-IL-1], Rep. Payne, Donald M., Jr. [D-NJ-10], Rep. Jackson Lee, Sheila [D-TX-18], Rep. Ryan, Tim [D-OH-13], Rep. Doyle, Michael F. [D-PA-14], Rep. Khanna, Ro [D-CA-17], Rep. Wasserman Schultz, Debbie [D-FL-23], Rep. Lujan, Ben Ray [D-NM-3], Rep. Ruiz, Raul [D-CA-36]
Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Cummings, Elijah E. [D-MD-7]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Lipinski, Daniel [D-IL-3]*, Rep. McCollum, Betty [D-MN-4]*, Rep. Castor, Kathy [D-FL-14]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Lynch, Stephen F. [D-MA-8]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Lujan Grisham, Michelle [D-NM-1]*, Rep. Cartwright, Matt [D-PA-17]*, Rep. Deutch, Theodore E. [D-FL-22], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Raskin, Jamie [D-MD-8], Rep. Loebsack, David [D-IA-2], Rep. Huffman, Jared [D-CA-2], Rep. Gabbard, Tulsi [D-HI-2], Rep. Blumenauer, Earl [D-OR-3], Rep. Visclosky, Peter J. [D-IN-1], Rep. Sherman, Brad [D-CA-30], Rep. Pingree, Chellie [D-ME-1], Rep. DeFazio, Peter A. [D-OR-4],Rep. Sarbanes, John P. [D-MD-3], Rep. Suozzi, Thomas R. [D-NY-3], Rep. Lofgren, Zoe [D-CA-19], Rep. Garamendi, John [D-CA-3], Rep. Maloney, Sean Patrick [D-NY-18], Rep. Langevin, James R. [D-RI-2], Rep. Gallego, Ruben [D-AZ-7], Rep. Takano, Mark [D-CA-41], Rep. Rush, Bobby L. [D-IL-1], Rep. Payne, Donald M., Jr. [D-NJ-10], Rep. Jackson Lee, Sheila [D-TX-18], Rep. Ryan, Tim [D-OH-13], Rep. Doyle, Michael F. [D-PA-14], Rep. Khanna, Ro [D-CA-17], Rep. Wasserman Schultz, Debbie [D-FL-23], Rep. Lujan, Ben Ray [D-NM-3], Rep. Ruiz, Raul [D-CA-36]
Rep. Rooney, Francis [R-FL-19]
Energy and Commerce, Ways and Means, Judiciary
01/25/2017 Referral to Subcommittee on HealthAmends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to negotiate with pharmaceutical companies regarding prices for drugs covered under the Medicare prescription drug benefit. Current law prohibits CMS from doing so.X
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H.R.749Lower Drug Costs through Competition ActRep. Schrader, Kurt [D-OR-5]01/30/201724
Rep. Bilirakis, Gus M. [R-FL-12]*, Rep. Lipinski, Daniel [D-IL-3]*, Rep. Moulton, Seth [D-MA-6]*, Rep. Bera, Ami [D-CA-7]*, Rep. Sinema, Kyrsten [D-AZ-9]*, Rep. Cooper, Jim [D-TN-5]*, Rep. Posey, Bill [R-FL-8]*, Rep. Costa, Jim [D-CA-16]*, Rep. Peters, Scott H. [D-CA-52]*, Rep. Peterson, Collin C. [D-MN-7], Rep. O'Halleran, Tom [D-AZ-1], Rep. Guthrie, Brett [R-KY-2], Rep. Cuellar, Henry [D-TX-28], Rep. Walz, Timothy J. [D-MN-1], Rep. Soto, Darren [D-FL-9], Rep. Bishop, Sanford D., Jr. [D-GA-2], Rep. Crist, Charlie [D-FL-13], Rep. Schneider, Bradley Scott [D-IL-10], Rep. Bacon, Don [R-NE-2], Rep. Fortenberry, Jeff [R-NE-1], Rep. Gonzalez-Colon, Jenniffer [R-PR-At Large], Rep. Gottheimer, Josh [D-NJ-5], Rep. Gianforte, Greg [R-MT-At Large], Rep. Knight, Stephen [R-CA-25]
Rep. Lipinski, Daniel [D-IL-3]*, Rep. Moulton, Seth [D-MA-6]*, Rep. Bera, Ami [D-CA-7]*, Rep. Sinema, Kyrsten [D-AZ-9]*, Rep. Cooper, Jim [D-TN-5]*, Rep. Costa, Jim [D-CA-16]*, Rep. Peters, Scott H. [D-CA-52]*, Rep. Peterson, Collin C. [D-MN-7], Rep. O'Halleran, Tom [D-AZ-1], Rep. Cuellar, Henry [D-TX-28], Rep. Walz, Timothy J. [D-MN-1], Rep. Soto, Darren [D-FL-9], Rep. Bishop, Sanford D., Jr. [D-GA-2], Rep. Crist, Charlie [D-FL-13], Rep. Schneider, Bradley Scott [D-IL-10], Rep. Gottheimer, Josh [D-NJ-5]
Rep. Bilirakis, Gus M. [R-FL-12]*, Rep. Posey, Bill [R-FL-8]*, Rep. Guthrie, Brett [R-KY-2], Rep. Bacon, Don [R-NE-2], Rep. Fortenberry, Jeff [R-NE-1], Rep. Gonzalez-Colon, Jenniffer [R-PR-At Large], Rep. Gianforte, Greg [R-MT-At Large], Rep. Knight, Stephen [R-CA-25]
Energy and Commerce02/03/2017 Referral to Subcommittee on HealthAmends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. Beginning FY2019, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the start of FY2024. The FDA must periodically report on generic drug applications filed before FY2018 that are still pending. For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.XX
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H.R.1223OPEN ActRep. Bilirakis, Gus M. [R-FL-12]02/27/201738
Rep. Butterfield, G. K. [D-NC-1]*, Rep. Soto, Darren [D-FL-9], Rep. Eshoo, Anna G. [D-CA-18], Rep. Norcross, Donald [D-NJ-1], Rep. Huffman, Jared [D-CA-2], Rep. Lofgren, Zoe [D-CA-19], Rep. Sires, Albio [D-NJ-8], Rep. Swalwell, Eric [D-CA-15], Rep. Shea-Porter, Carol [D-NH-1], Rep. Clay, Wm. Lacy [D-MO-1], Rep. Hastings, Alcee L. [D-FL-20], Rep. Lujan Grisham, Michelle [D-NM-1], Rep. Rice, Kathleen M. [D-NY-4], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Visclosky, Peter J. [D-IN-1], Rep. McCaul, Michael T. [R-TX-10]*, Rep. Lance, Leonard [R-NJ-7], Rep. Frelinghuysen, Rodney P. [R-NJ-11], Rep. Murphy, Tim [R-PA-18], Rep. Donovan, Daniel M., Jr. [R-NY-11], Rep. Mullin, Markwayne [R-OK-2], Rep. Fortenberry, Jeff [R-NE-1], Rep. Bacon, Don [R-NE-2], Rep. Webster, Daniel [R-FL-11], Rep. Palazzo, Steven M. [R-MS-4], Rep. Rooney, Francis [R-FL-19], Rep. McMorris Rodgers, Cathy [R-WA-5], Rep. Upton, Fred [R-MI-6], Rep. Olson, Pete [R-TX-22], Rep. Long, Billy [R-MO-7], Rep. Brooks, Mo [R-AL-5], Rep. Stivers, Steve [R-OH-15], Rep. Comstock, Barbara [R-VA-10], Rep. Smith, Christopher H. [R-NJ-4], Rep. Fitzpatrick, Brian K. [R-PA-8], Rep. Young, David [R-IA-3], Rep. Culberson, John Abney [R-TX-7], Rep. Reichert, David G. [R-WA-8]
Rep. Butterfield, G. K. [D-NC-1]*, Rep. Soto, Darren [D-FL-9], Rep. Eshoo, Anna G. [D-CA-18], Rep. Norcross, Donald [D-NJ-1], Rep. Huffman, Jared [D-CA-2], Rep. Lofgren, Zoe [D-CA-19], Rep. Sires, Albio [D-NJ-8], Rep. Swalwell, Eric [D-CA-15], Rep. Shea-Porter, Carol [D-NH-1], Rep. Clay, Wm. Lacy [D-MO-1], Rep. Hastings, Alcee L. [D-FL-20], Rep. Lujan Grisham, Michelle [D-NM-1], Rep. Rice, Kathleen M. [D-NY-4], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Visclosky, Peter J. [D-IN-1]
Rep. McCaul, Michael T. [R-TX-10]*, Rep. Lance, Leonard [R-NJ-7], Rep. Frelinghuysen, Rodney P. [R-NJ-11], Rep. Murphy, Tim [R-PA-18], Rep. Donovan, Daniel M., Jr. [R-NY-11], Rep. Mullin, Markwayne [R-OK-2], Rep. Fortenberry, Jeff [R-NE-1], Rep. Bacon, Don [R-NE-2], Rep. Webster, Daniel [R-FL-11], Rep. Palazzo, Steven M. [R-MS-4], Rep. Rooney, Francis [R-FL-19], Rep. McMorris Rodgers, Cathy [R-WA-5], Rep. Upton, Fred [R-MI-6], Rep. Olson, Pete [R-TX-22], Rep. Long, Billy [R-MO-7], Rep. Brooks, Mo [R-AL-5], Rep. Stivers, Steve [R-OH-15], Rep. Comstock, Barbara [R-VA-10], Rep. Smith, Christopher H. [R-NJ-4], Rep. Fitzpatrick, Brian K. [R-PA-8], Rep. Young, David [R-IA-3], Rep. Culberson, John Abney [R-TX-7], Rep. Reichert, David G. [R-WA-8]
Energy and Commerce03/03/2017 Referral to Subcommittee on HealthAmends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.X
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H.R.1245Affordable and Safe Prescription Drug Importation ActRep. Cummings, Elijah E. [D-MD-7] 02/28/201728
Rep. Doggett, Lloyd [D-TX-35]*, Rep. Moore, Gwen [D-WI-4]*, Rep. Brady, Robert A. [D-PA-1]*, Rep. Khanna, Ro [D-CA-17]*, Rep. Cohen, Steve [D-TN-9]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Jayapal, Pramila [D-WA-7]*, Rep. Lee, Barbara [D-CA-13]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. Norton, Eleanor Holmes [D-DC-At Large]*, Rep. Pingree, Chellie [D-ME-1]*, Rep. Welch, Peter [D-VT-At Large]*, Rep. Blumenauer, Earl [D-OR-3]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Langevin, James R. [D-RI-2]*, Rep. Sherman, Brad [D-CA-30]*, Rep. Ellison, Keith [D-MN-5], Rep. O'Rourke, Beto [D-TX-16], Rep. Gabbard, Tulsi [D-HI-2], Rep. Polis, Jared [D-CO-2], Rep. Visclosky, Peter J. [D-IN-1], Rep. Raskin, Jamie [D-MD-8], Rep. Napolitano, Grace F. [D-CA-32], Rep. Garamendi, John [D-CA-3], Rep. Rush, Bobby L. [D-IL-1], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Lujan Grisham, Michelle [D-NM-1]
Rep. Doggett, Lloyd [D-TX-35]*, Rep. Moore, Gwen [D-WI-4]*, Rep. Brady, Robert A. [D-PA-1]*, Rep. Khanna, Ro [D-CA-17]*, Rep. Cohen, Steve [D-TN-9]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Jayapal, Pramila [D-WA-7]*, Rep. Lee, Barbara [D-CA-13]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. Norton, Eleanor Holmes [D-DC-At Large]*, Rep. Pingree, Chellie [D-ME-1]*, Rep. Welch, Peter [D-VT-At Large]*, Rep. Blumenauer, Earl [D-OR-3]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Langevin, James R. [D-RI-2]*, Rep. Sherman, Brad [D-CA-30]*, Rep. Ellison, Keith [D-MN-5], Rep. O'Rourke, Beto [D-TX-16], Rep. Gabbard, Tulsi [D-HI-2], Rep. Polis, Jared [D-CO-2], Rep. Visclosky, Peter J. [D-IN-1], Rep. Raskin, Jamie [D-MD-8], Rep. Napolitano, Grace F. [D-CA-32], Rep. Garamendi, John [D-CA-3], Rep. Rush, Bobby L. [D-IL-1], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Lujan Grisham, Michelle [D-NM-1]
-Energy and Commerce02/28/2017 Introduced in HouseAmends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals.X
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H.R.1316Prescription Drug Price Transparency ActRep. Collins, Doug [R-GA-9]03/02/201755
Rep. Loebsack, David [D-IA-2]*, Rep. Carter, Earl L. "Buddy" [R-GA-1]*, Rep. Duncan, John J., Jr. [R-TN-2]*, Rep. McMorris Rodgers, Cathy [R-WA-5]*, Rep. Blum, Rod [R-IA-1]*, Rep. Sarbanes, John P. [D-MD-3]*, Rep. Babin, Brian [R-TX-36]*, Rep. Langevin, James R. [D-RI-2], Rep. Wittman, Robert J. [R-VA-1], Rep. Allen, Rick W. [R-GA-12], Rep. Aderholt, Robert B. [R-AL-4], Rep. Scott, Austin [R-GA-8], Rep. Welch, Peter [D-VT-At Large], Rep. Brooks, Mo [R-AL-5], Rep. Peterson, Collin C. [D-MN-7], Rep. Cummings, Elijah E. [D-MD-7], Rep. Graves, Tom [R-GA-14], Rep. Rouzer, David [R-NC-7], Rep. Rogers, Mike D. [R-AL-3], Rep. Crawford, Eric A. "Rick" [R-AR-1], Rep. Barletta, Lou [R-PA-11], Rep. Jones, Walter B., Jr. [R-NC-3], Rep. Vela, Filemon [D-TX-34], Rep. Harper, Gregg [R-MS-3], Rep. Stefanik, Elise M. [R-NY-21], Rep. Palazzo, Steven M. [R-MS-4], Rep. Griffith, H. Morgan [R-VA-9], Rep. Ferguson, A. Drew, IV [R-GA-3], Rep. Bacon, Don [R-NE-2], Rep. Marshall, Roger W. [R-KS-1], Rep. Byrne, Bradley [R-AL-1], Rep. Roe, David P. [R-TN-1], Rep. Hice, Jody B. [R-GA-10], Rep. Young, David [R-IA-3], Rep. Newhouse, Dan [R-WA-4], Rep. Westerman, Bruce [R-AR-4], Rep. Cramer, Kevin [R-ND-At Large], Rep. Raskin, Jamie [D-MD-8], Rep. King, Peter T. [R-NY-2], Rep. Rice, Kathleen M. [D-NY-4], Rep. Ryan, Tim [D-OH-13], Rep. Gallagher, Mike [R-WI-8], Rep. Beatty, Joyce [D-OH-3], Rep. Hartzler, Vicky [R-MO-4], Rep. Herrera Beutler, Jaime [R-WA-3], Rep. King, Steve [R-IA-4], Rep. Gonzalez, Vicente [D-TX-15], Rep. Roby, Martha [R-AL-2], Rep. Higgins, Clay [R-LA-3], Rep. Goodlatte, Bob [R-VA-6], Rep. Abraham, Ralph Lee [R-LA-5], Rep. Khanna, Ro [D-CA-17], Rep. DesJarlais, Scott [R-TN-4], Rep. Posey, Bill [R-FL-8], Rep. Clarke, Yvette D. [D-NY-9], Rep. Poliquin, Bruce [R-ME-2]
Rep. Loebsack, David [D-IA-2]*, Rep. Langevin, James R. [D-RI-2], Rep. Sarbanes, John P. [D-MD-3]*, Rep. Welch, Peter [D-VT-At Large], Rep. Cummings, Elijah E. [D-MD-7], Rep. Vela, Filemon [D-TX-34], Rep. Peterson, Collin C. [D-MN-7], Rep. Raskin, Jamie [D-MD-8], Rep. Rice, Kathleen M. [D-NY-4], Rep. Ryan, Tim [D-OH-13], Rep. Beatty, Joyce [D-OH-3], Rep. Gonzalez, Vicente [D-TX-15], Rep. Khanna, Ro [D-CA-17], Rep. Clarke, Yvette D. [D-NY-9]
Rep. Carter, Earl L. "Buddy" [R-GA-1]*, Rep. Duncan, John J., Jr. [R-TN-2]*, Rep. McMorris Rodgers, Cathy [R-WA-5]*, Rep. Blum, Rod [R-IA-1]*, Rep. Babin, Brian [R-TX-36]*, Rep. Wittman, Robert J. [R-VA-1], Rep. Allen, Rick W. [R-GA-12], Rep. Aderholt, Robert B. [R-AL-4], Rep. Scott, Austin [R-GA-8], Rep. Brooks, Mo [R-AL-5], Rep. Graves, Tom [R-GA-14], Rep. Rouzer, David [R-NC-7], Rep. Rogers, Mike D. [R-AL-3], Rep. Crawford, Eric A. "Rick" [R-AR-1], Rep. Barletta, Lou [R-PA-11], Rep. Jones, Walter B., Jr. [R-NC-3], Rep. Harper, Gregg [R-MS-3], Rep. Stefanik, Elise M. [R-NY-21], Rep. Palazzo, Steven M. [R-MS-4], Rep. Griffith, H. Morgan [R-VA-9], Rep. Ferguson, A. Drew, IV [R-GA-3], Rep. Bacon, Don [R-NE-2], Rep. Marshall, Roger W. [R-KS-1], Rep. Byrne, Bradley [R-AL-1], Rep. Roe, David P. [R-TN-1], Rep. Hice, Jody B. [R-GA-10], Rep. Young, David [R-IA-3], Rep. Newhouse, Dan [R-WA-4], Rep. Westerman, Bruce [R-AR-4], Rep. Cramer, Kevin [R-ND-At Large], Rep. King, Peter T. [R-NY-2], Rep. Gallagher, Mike [R-WI-8], Rep. Hartzler, Vicky [R-MO-4], Rep. Herrera Beutler, Jaime [R-WA-3], Rep. King, Steve [R-IA-4], Rep. Roby, Martha [R-AL-2], Rep. Higgins, Clay [R-LA-3], Rep. Goodlatte, Bob [R-VA-6], Rep. Abraham, Ralph Lee [R-LA-5], Rep. DesJarlais, Scott [R-TN-4], Rep. Posey, Bill [R-FL-8], Rep. Poliquin, Bruce [R-ME-2]
Energy and Commerce, Ways and Means, Armed Services, Oversight and Government Reform
04/05/2017 Referral to Subcommittee on Military PersonnelAdds certain transparency requirements for pharmacy benefits managers under Medicare, Medicare Advantage, TRICARE, and the Federal Employees Health Benefits Program.XX
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H.R.1776Improving Access To Affordable Prescription Drugs ActRep. Schakowsky, Janice D. [D-IL-9]03/29/201722
Rep. Cummings, Elijah E. [D-MD-7]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Welch, Peter [D-VT-At Large]*, Rep. Grijalva, Raul M. [D-AZ-3], Rep. Pocan, Mark [D-WI-2], Rep. Conyers, John, Jr. [D-MI-13], Rep. Peterson, Collin C. [D-MN-7], Rep. Shea-Porter, Carol [D-NH-1], Rep. Barragan, Nanette Diaz [D-CA-44], Rep. Ellison, Keith [D-MN-5], Rep. Rush, Bobby L. [D-IL-1], Rep. Pingree, Chellie [D-ME-1], Rep. Nolan, Richard M. [D-MN-8], Rep. Chu, Judy [D-CA-27], Rep. Cohen, Steve [D-TN-9], Rep. McCollum, Betty [D-MN-4], Rep. Jayapal, Pramila [D-WA-7], Rep. DeFazio, Peter A. [D-OR-4], Rep. Ryan, Tim [D-OH-13], Rep. Visclosky, Peter J. [D-IN-1], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Khanna, Ro [D-CA-17]
Rep. Cummings, Elijah E. [D-MD-7]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Welch, Peter [D-VT-At Large]*, Rep. Grijalva, Raul M. [D-AZ-3], Rep. Pocan, Mark [D-WI-2], Rep. Conyers, John, Jr. [D-MI-13], Rep. Peterson, Collin C. [D-MN-7], Rep. Shea-Porter, Carol [D-NH-1], Rep. Barragan, Nanette Diaz [D-CA-44], Rep. Ellison, Keith [D-MN-5], Rep. Rush, Bobby L. [D-IL-1], Rep. Pingree, Chellie [D-ME-1], Rep. Nolan, Richard M. [D-MN-8], Rep. Chu, Judy [D-CA-27], Rep. Cohen, Steve [D-TN-9], Rep. McCollum, Betty [D-MN-4], Rep. Jayapal, Pramila [D-WA-7], Rep. DeFazio, Peter A. [D-OR-4], Rep. Ryan, Tim [D-OH-13], Rep. Visclosky, Peter J. [D-IN-1], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Khanna, Ro [D-CA-17]
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Energy and Commerce, Ways and Means, Judiciary
04/05/2017 Referral to Subcommittee on HealthAmends provisions of various laws relating to prescription-drug pricing and affordability. Specifically, the bill: expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures; requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under the Medicare program; requires the GAO to report to Congress on such negotiations conducted by the CMS; requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models for negotiating drug prices; establishes reporting requirements, and corresponding civil penalties for noncompliance, for pharmaceutical companies with respect to spikes in prescription-drug prices; establishes an excise tax on prescription drugs subject to price spikes; lessens prescription-drug cost-sharing requirements under qualified health plans, group health plans, and the Medicare program; modifies provisions related to the importation of prescription drugs; requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program; establishes a prize fund for new and more effective treatments of bacterial infections; establishes a Center for Clinical Research within the National Institutes of Health; modifies provisions related to drug exclusivity; allows the Federal Trade Commission to initiate enforcement proceedings against parties to an agreement resolving or settling a patent-infringement claim in connection with the sale of a drug product; requires the Food and Drug Administration to establish a database of generic drugs; and modifies other provisions related to generic drugs, prescription-drug advertising, and product hopping.XXXXXXXXXXX
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H.R.2051FAST Generics Act of 2017Rep. McKinley, David B. [R-WV-1]04/06/201710
Rep. Welch, Peter [D-VT-At Large]*, Rep. Schrader, Kurt [D-OR-5], Rep. DeGette, Diana [D-CO-1], Rep. Lipinski, Daniel [D-IL-3], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Cartwright, Matt [D-PA-17], Rep. Khanna, Ro [D-CA-17], Rep. Stivers, Steve [R-OH-15], Rep. Fortenberry, Jeff [R-NE-1], Rep. Renacci, James B. [R-OH-16], Rep. Lujan Grisham, Michelle [D-NM-1]
Rep. Welch, Peter [D-VT-At Large]*, Rep. Schrader, Kurt [D-OR-5], Rep. DeGette, Diana [D-CO-1], Rep. Lipinski, Daniel [D-IL-3], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Cartwright, Matt [D-PA-17], Rep. Khanna, Ro [D-CA-17], Rep. Lujan Grisham, Michelle [D-NM-1]
Rep. Stivers, Steve [R-OH-15], Rep. Fortenberry, Jeff [R-NE-1], Rep. Renacci, James B. [R-OH-16]
Energy and Commerce04/06/2017 Introduced in HouseAmends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing. For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication. A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health. License holders are not liable for claims arising from a product developer testing a medication. The FDA may waive the requirement that a medication use a single, shared system of elements to assure safe use with a comparable approved medication if the product developer is unable to finalize terms for a shared system with the license holder of the approved medication.XX
9
H.R.2212CREATES Act of 2017Rep. Marino, Tom [R-PA-10] 04/27/201721
Rep. Cicilline, David N. [D-RI-1]*, Rep. Meadows, Mark [R-NC-11], Rep. Welch, Peter [D-VT-At Large], Rep. Rokita, Todd [R-IN-4], Rep. Cohen, Steve [D-TN-9], Rep. Kaptur, Marcy [D-OH-9], Rep. Rooney, Francis [R-FL-19], Rep. Gallagher, Mike [R-WI-8], Rep. Shea-Porter, Carol [D-NH-1], Rep. Duncan, John J., Jr. [R-TN-2], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Culberson, John Abney [R-TX-7], Rep. Doggett, Lloyd [D-TX-35], Rep. Brat, Dave [R-VA-7], Rep. Thompson, Bennie G. [D-MS-2], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Gibbs, Bob [R-OH-7], Rep. DeFazio, Peter A. [D-OR-4], Rep. Barr, Andy [R-KY-6], Rep. O'Rourke, Beto [D-TX-16], Rep. Renacci, James B. [R-OH-16], Rep. King, Peter T. [R-NY-2], Rep. Raskin, Jamie [D-MD-8]
Rep. Cicilline, David N. [D-RI-1]*, Rep. Welch, Peter [D-VT-At Large], Rep. Cohen, Steve [D-TN-9], Rep. Kaptur, Marcy [D-OH-9], Rep. Shea-Porter, Carol [D-NH-1], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Doggett, Lloyd [D-TX-35], Rep. Thompson, Bennie G. [D-MS-2], Janice D. [D-IL-9], Rep. DeFazio, Peter A. [D-OR-4], Rep. O'Rourke, Beto [D-TX-16], Rep. Raskin, Jamie [D-MD-8]
Rep. Meadows, Mark [R-NC-11], Rep. Rokita, Todd [R-IN-4], Rep. Rooney, Francis [R-FL-19], Rep. Gallagher, Mike [R-WI-8], Rep. Duncan, John J., Jr. [R-TN-2], Rep. Culberson, John Abney [R-TX-7], Rep. Brat, Dave [R-VA-7], Rep. Schakowsky, Rep. Gibbs, Bob [R-OH-7], Rep. Barr, Andy [R-KY-6], Rep. Renacci, James B. [R-OH-16], Rep. King, Peter T. [R-NY-2]
Energy and Commerce, Judiciary
04/28/2017 Referral to Subcommittee on HealthPromotes competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.XX
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H.R.2439Fair Accountability and Innovative Research Drug Pricing Act of 2017Rep. Schakowsky, Janice D. [D-IL-9]05/16/201721
Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Doggett, Lloyd [D-TX-35]*, Rep. Cummings, Elijah E. [D-MD-7]*, Rep. Welch, Peter [D-VT-At Large]*, Rep. Yarmuth, John A. [D-KY-3], Rep. Castor, Kathy [D-FL-14], Rep. Cohen, Steve [D-TN-9], Rep. Pingree, Chellie [D-ME-1], Rep. Lujan Grisham, Michelle [D-NM-1], Rep. Doyle, Michael F. [D-PA-14], Rep. Walz, Timothy J. [D-MN-1], Rep. Pocan, Mark [D-WI-2], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Thompson, Bennie G. [D-MS-2], Rep. Cleaver, Emanuel [D-MO-5], Rep. Chu, Judy [D-CA-27], Rep. Jackson Lee, Sheila [D-TX-18], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Raskin, Jamie [D-MD-8], Rep. Khanna, Ro [D-CA-17], Rep. McCollum, Betty [D-MN-4], Rep. Rooney, Francis [R-FL-19]
Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Doggett, Lloyd [D-TX-35]*, Rep. Cummings, Elijah E. [D-MD-7]*, Rep. Welch, Peter [D-VT-At Large]*, Rep. Yarmuth, John A. [D-KY-3], Rep. Castor, Kathy [D-FL-14], Rep. Cohen, Steve [D-TN-9], Rep. Pingree, Chellie [D-ME-1], Rep. Lujan Grisham, Michelle [D-NM-1], Rep. Doyle, Michael F. [D-PA-14], Rep. Walz, Timothy J. [D-MN-1], Rep. Pocan, Mark [D-WI-2], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Thompson, Bennie G. [D-MS-2], Rep. Cleaver, Emanuel [D-MO-5], Rep. Chu, Judy [D-CA-27], Rep. Jackson Lee, Sheila [D-TX-18], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Raskin, Jamie [D-MD-8], Rep. Khanna, Ro [D-CA-17], Rep. McCollum, Betty [D-MN-4]
Rep. Rooney, Francis [R-FL-19]
Energy and Commerce05/19/2017 Referral to Subcommittee on HealthAmends the Public Health Service Act to require manufacturers of certain drugs and biological products with a wholesale cost of $100 or more per month to report to the Department of Health and Human Services (HHS) price increases that result in a 10% or more increase in the cost of a drug over a 12-month period or a 25% or more increase over a 36-month period. Reports are required for prescription drugs and drugs commonly administered in hospitals, except vaccines, drugs for rare conditions, and drugs with annual sales for Medicare and Medicaid enrollees of less than $1. Reports must contain specified information including pricing history and a justification for each price increase in the relevant period. Manufacturers that do not submit a required report are subject to a civil penalty. Collected penalty funds must be used to carry out activities related to this reporting requirement and to improve consumer and provider information about drug value and drug price transparency. HHS must publish manufacturer reports, a summary of those reports, and supporting analyses.XXX
11
H.R.2562Making Pharmaceutical Markets More Competitive ActRep. Kelly, Mike [R-PA-3] 05/19/20170---Energy and Commerce05/26/2017 Referral to Subcommittee on HealthAmends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to prioritize the review of generic drug applications and supplements with respect to drugs that are in a shortage or for which there are not more than three approved drugs. The holder of an approved drug application must notify the FDA within 180 days of withdrawing or transferring the application or withdrawing the drug from sale. The FDA must maintain a list of generic drugs with three or fewer holders of approved applications.X
12
H.R.2641Promoting Life-Saving New Therapies for Neonates Act of 2017Rep. Long, Billy [R-MO-7]05/24/201737
Rep. Lujan, Ben Ray [D-NM-3]*, Rep. Napolitano, Grace F. [D-CA-32], Rep. Garamendi, John [D-CA-3], Rep. Pascrell, Bill, Jr. [D-NJ-9], Rep. Cardenas, Tony [D-CA-29], Rep. Kilmer, Derek [D-WA-6], Rep. Moulton, Seth [D-MA-6], Rep. Connolly, Gerald E. [D-VA-11], Rep. Rice, Kathleen M. [D-NY-4], Rep. Peters, Scott H. [D-CA-52], Rep. DeSaulnier, Mark [D-CA-11], Rep. Blunt Rochester, Lisa [D-DE-At Large], Rep. Guthrie, Brett [R-KY-2], Rep. Lance, Leonard [R-NJ-7], Rep. Poliquin, Bruce [R-ME-2], Rep. Jenkins, Lynn [R-KS-2], Rep. Aguilar, Pete [D-CA-31], Rep. Tipton, Scott R. [R-CO-3], Rep. Mooney, Alexander X. [R-WV-2], Rep. Paulsen, Erik [R-MN-3], Rep. Kind, Ron [D-WI-3], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Smith, Jason [R-MO-8], Rep. Moore, Gwen [D-WI-4], Rep. Maloney, Sean Patrick [D-NY-18], Rep. Norcross, Donald [D-NJ-1], Rep. Hudson, Richard [R-NC-8], Rep. Veasey, Marc A. [D-TX-33], Rep. Frelinghuysen, Rodney P. [R-NJ-11], Rep. King, Peter T. [R-NY-2], Rep. Roskam, Peter J. [R-IL-6], Rep. Rush, Bobby L. [D-IL-1], Rep. Price, David E. [D-NC-4], Rep. Marshall, Roger W. [R-KS-1], Rep. Eshoo, Anna G. [D-CA-18], Rep. Plaskett, Stacey E. [D-VI-At Large], Rep. Ruiz, Raul [D-CA-36]
Rep. Lujan, Ben Ray [D-NM-3]*, Rep. Napolitano, Grace F. [D-CA-32], Rep. Garamendi, John [D-CA-3], Rep. Pascrell, Bill, Jr. [D-NJ-9], Rep. Cardenas, Tony [D-CA-29], Rep. Kilmer, Derek [D-WA-6], Rep. Moulton, Seth [D-MA-6], Rep. Connolly, Gerald E. [D-VA-11], Rep. Rice, Kathleen M. [D-NY-4], Rep. Peters, Scott H. [D-CA-52], Rep. DeSaulnier, Mark [D-CA-11], Rep. Blunt Rochester, Lisa [D-DE-At Large], Rep. Aguilar, Pete [D-CA-31], Rep. Kind, Ron [D-WI-3], Rep. Moore, Gwen [D-WI-4], Rep. Maloney, Sean Patrick [D-NY-18], Rep. Norcross, Donald [D-NJ-1], Rep. Veasey, Marc A. [D-TX-33], Rep. Rush, Bobby L. [D-IL-1], Rep. Price, David E. [D-NC-4], Rep. Eshoo, Anna G. [D-CA-18], Rep. Plaskett, Stacey E. [D-VI-At Large], Rep. Ruiz, Raul [D-CA-36]
Rep. Guthrie, Brett [R-KY-2], Rep. Lance, Leonard [R-NJ-7], Rep. Poliquin, Bruce [R-ME-2], Rep. Jenkins, Lynn [R-KS-2], Rep. Tipton, Scott R. [R-CO-3], Rep. Mooney, Alexander X. [R-WV-2], Rep. Paulsen, Erik [R-MN-3], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Smith, Jason [R-MO-8], Rep. Hudson, Richard [R-NC-8], Rep. Frelinghuysen, Rodney P. [R-NJ-11], Rep. King, Peter T. [R-NY-2], Rep. Roskam, Peter J. [R-IL-6], Rep. Marshall, Roger W. [R-KS-1]
Energy and Commerce05/26/2017 Referral to Subcommittee on HealtAmends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award the sponsor of a new drug or biological product for the treatment of newborns a neonatal drug exclusivity voucher upon approval of the medication. A neonatal drug exclusivity voucher is a transferable voucher for a one-year extension of all existing patents and marketing exclusivities for a brand name medication. For a sponsor to be eligible for a voucher, the new medication must: (1) treat a condition identified in the Priority List of Critical Needs for Neonates required under this bill, and (2) have been studied in newborns. A voucher may be revoked if the new medication is not marketed in the United States within one year of approval. A voucher may not be used: (1) to extend the marketing exclusivity period for a drug for which the FDA requires an assessment of the safety and effectiveness in newborns, or (2) on the same product as a priority review voucher. A sponsor intending to use a voucher must notify the FDA at least 15 months before the expiration of the patents or exclusivity to be extended. The Government Accountability Office must study the effectiveness of this voucher program.X
13
H.R.3536To require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human ServicesRep. DeFazio, Peter A. [D-OR-4]07/28/20177
Rep. Conyers, John, Jr. [D-MI-13], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Kaptur, Marcy [D-OH-9], Rep. Cummings, Elijah E. [D-MD-7], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Khanna, Ro [D-CA-17]
Rep. Conyers, John, Jr. [D-MI-13], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Kaptur, Marcy [D-OH-9], Rep. Cummings, Elijah E. [D-MD-7], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Khanna, Ro [D-CA-17]
-Energy and Commerce08/04/2017 Referral to Subcommittee on HealthRequires persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.X
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H.R.4116Transparent Drug Pricing Act of 2017Rep. Doggett, Lloyd [D-TX-35] 10/25/201731
Rep. Cummings, Elijah E. [D-MD-7]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Conyers, John, Jr. [D-MI-13]*, Rep. Higgins, Brian [D-NY-26]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Nadler, Jerrold [D-NY-10]*, Rep. Raskin, Jamie [D-MD-8]*, Rep. Jayapal, Pramila [D-WA-7], Rep. Welch, Peter [D-VT-At Large], Rep. Chu, Judy [D-CA-27], Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4], Rep. Blumenauer, Earl [D-OR-3], Rep. Pingree, Chellie [D-ME-1], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Khanna, Ro [D-CA-17], Rep. Green, Al [D-TX-9], Rep. Cleaver, Emanuel [D-MO-5], Rep. Shea-Porter, Carol [D-NH-1], Rep. Napolitano, Grace F. [D-CA-32], Rep. Gonzalez, Vicente [D-TX-15], Rep. DeSaulnier, Mark [D-CA-11], Rep. Moore, Gwen [D-WI-4], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Thompson, Bennie G. [D-MS-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Bass, Karen [D-CA-37]
Rep. Cummings, Elijah E. [D-MD-7]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Conyers, John, Jr. [D-MI-13]*, Rep. Higgins, Brian [D-NY-26]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Nadler, Jerrold [D-NY-10]*, Rep. Raskin, Jamie [D-MD-8]*, Rep. Jayapal, Pramila [D-WA-7], Rep. Welch, Peter [D-VT-At Large], Rep. Chu, Judy [D-CA-27], Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4], Rep. Blumenauer, Earl [D-OR-3], Rep. Pingree, Chellie [D-ME-1], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Khanna, Ro [D-CA-17], Rep. Green, Al [D-TX-9], Rep. Cleaver, Emanuel [D-MO-5], Rep. Shea-Porter, Carol [D-NH-1], Rep. Napolitano, Grace F. [D-CA-32], Rep. Gonzalez, Vicente [D-TX-15], Rep. DeSaulnier, Mark [D-CA-11], Rep. Moore, Gwen [D-WI-4], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Thompson, Bennie G. [D-MS-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Bass, Karen [D-CA-37]
-Energy and Commerce10/27/2017 Referral to Subcommittee on HealthAmends the Public Health Service Act to require reporting by drug manufacturers to increase transparency in drug pricing, and for other purposes.XX
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H.R.4117Competitive DRUGS Act of 2017Rep. Doggett, Lloyd [D-TX-35]10/25/201735
Rep. Cummings, Elijah E. [D-MD-7]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Chu, Judy [D-CA-27]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Conyers, John, Jr. [D-MI-13]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Khanna, Ro [D-CA-17]*, Rep. Langevin, James R. [D-RI-2]*, Rep. Nadler, Jerrold [D-NY-10]*, Rep. Napolitano, Grace F. [D-CA-32]*, Rep. O'Rourke, Beto [D-TX-16]*, Rep. Pingree, Chellie [D-ME-1]*, Rep. Castor, Kathy [D-FL-14]*, Rep. Raskin, Jamie [D-MD-8]*, Rep. Velazquez, Nydia M. [D-NY-7]*, Rep. Jayapal, Pramila [D-WA-7], Rep. Welch, Peter [D-VT-At Large], Rep. Blumenauer, Earl [D-OR-3], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Cartwright, Matt [D-PA-17], Rep. Larson, John B. [D-CT-1], Rep. Green, Al [D-TX-9], Rep. Cleaver, Emanuel [D-MO-5], Rep. Shea-Porter, Carol [D-NH-1], Rep. Gonzalez, Vicente [D-TX-15], Rep. DeSaulnier, Mark [D-CA-11], Rep. Moore, Gwen [D-WI-4], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Thompson, Bennie G. [D-MS-2], Rep. Bass, Karen [D-CA-37]
Rep. Cummings, Elijah E. [D-MD-7]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Chu, Judy [D-CA-27]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Conyers, John, Jr. [D-MI-13]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Khanna, Ro [D-CA-17]*, Rep. Langevin, James R. [D-RI-2]*, Rep. Nadler, Jerrold [D-NY-10]*, Rep. Napolitano, Grace F. [D-CA-32]*, Rep. O'Rourke, Beto [D-TX-16]*, Rep. Pingree, Chellie [D-ME-1]*, Rep. Castor, Kathy [D-FL-14]*, Rep. Raskin, Jamie [D-MD-8]*, Rep. Velazquez, Nydia M. [D-NY-7]*, Rep. Jayapal, Pramila [D-WA-7], Rep. Welch, Peter [D-VT-At Large], Rep. Blumenauer, Earl [D-OR-3], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Cartwright, Matt [D-PA-17], Rep. Larson, John B. [D-CT-1], Rep. Green, Al [D-TX-9], Rep. Cleaver, Emanuel [D-MO-5], Rep. Shea-Porter, Carol [D-NH-1], Rep. Gonzalez, Vicente [D-TX-15], Rep. DeSaulnier, Mark [D-CA-11], Rep. Moore, Gwen [D-WI-4], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Thompson, Bennie G. [D-MS-2], Rep. Bass, Karen [D-CA-37]
-
Ways and Means, Judiciary, Energy and Commerce
10/27/2017 Referral to Subcommittee on Digital Commerce and Consumer ProtectionProhibits brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes.X
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H.R.5340STRONGER Patents Act of 2018Rep. Stivers, Steve [R-OH-15]03/20/201820
Rep. Foster, Bill [D-IL-11], Rep. Davidson, Warren [R-OH-8], Rep. Duffy, Sean P. [R-WI-7], Rep. Cramer, Kevin [R-ND-At Large], Rep. King, Peter T. [R-NY-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Huizenga, Bill [R-MI-2], Rep. Joyce, David P. [R-OH-14], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Davis, Danny K. [D-IL-7], Rep. Rush, Bobby L. [D-IL-1], Rep. Boyle, Brendan F. [D-PA-13], Rep. Peters, Scott H. [D-CA-52], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Gosar, Paul A. [R-AZ-4], Rep. Blunt Rochester, Lisa [D-DE-At Large], Rep. Hill, J. French [R-AR-2], Rep. Hultgren, Randy [R-IL-14], Rep. Norman, Ralph [R-SC-5], Rep. Suozzi, Thomas R. [D-NY-3]
Rep. Foster, Bill [D-IL-11], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Davis, Danny K. [D-IL-7], Rep. Rush, Bobby L. [D-IL-1], Rep. Boyle, Brendan F. [D-PA-13], Rep. Peters, Scott H. [D-CA-52], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Suozzi, Thomas R. [D-NY-3], Rep. Blunt Rochester, Lisa [D-DE-At Large]
Rep. Davidson, Warren [R-OH-8], Rep. Duffy, Sean P. [R-WI-7], Rep. Cramer, Kevin [R-ND-At Large], Rep. King, Peter T. [R-NY-2], Rep. Huizenga, Bill [R-MI-2], Rep. Joyce, David P. [R-OH-14], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Gosar, Paul A. [R-AZ-4], Rep. Hill, J. French [R-AR-2], Rep. Hultgren, Randy [R-IL-14], Rep. Norman, Ralph [R-SC-5], Rep. Bacon, Don [R-NE-2], Rep. Babin, Brian [R-TX-36], Rep. Burgess, Michael C. [R-TX-26]
Judiciary, Energy and Commerce
04/30/2018 Referral to Subcommittee on Courts, Intellectual Property, and the InternetAmends the inter partes review, post-grant review process; overules eBay v. MercExchange, and other XX
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H.R.5739Prescription Drug and Medical Device Price Review Board Act of 2018Rep. DeLauro, Rosa L. [D-CT-3]05/09/20182
Rep. Doggett, Lloyd [D-TX-35], Rep. Moore, Gwen [D-WI-4]
Rep. Doggett, Lloyd [D-TX-35], Rep. Moore, Gwen [D-WI-4]
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Energy and Commerce, Ways and Means, Judiciary
05/25/2018 Referral to Subcommittee on HealthEstablishes within the Department of Health and Human Services the Prescription Drug and Medical Device Price Review Board to regulate the prices of certain prescription drugs and medical devices, and for other purposes.X
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H.R.5958Phair Pricing Act of 2018Rep. Collins, Doug [R-GA-9] 05/24/20185
Rep. Gonzalez, Vicente [D-TX-15]*, Rep. Carter, Earl L. "Buddy" [R-GA-1]*, Rep. Duncan, John J., Jr. [R-TN-2]*, Rep. Roe, David P. [R-TN-1], Rep. Crawford, Eric A. "Rick" [R-AR-1]
Rep. Gonzalez, Vicente [D-TX-15]*
Rep. Carter, Earl L. "Buddy" [R-GA-1]*, Rep. Duncan, John J., Jr. [R-TN-2]*, Rep. Roe, David P. [R-TN-1], Rep. Crawford, Eric A. "Rick" [R-AR-1]
Energy and Commerce, Ways and Means
05/24/2018 Introduced in HouseAmends title XVIII of the Social Security Act to require pharmacy-negotiated price concessions and pharmacy incentive payments and adjustments to be included in negotiated prices at the point-of-sale under part D of the Medicare program, and for other purposes.X
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H.R.6143Patient Right to Know Drug Prices ActRep. Doggett, Lloyd [D-TX-35]06/19/201821
Rep. Levin, Sander M. [D-MI-9], Rep. Cummings, Elijah E. [D-MD-7], Rep. Lewis, John [D-GA-5], Rep. Pocan, Mark [D-WI-2] Rep. Raskin, Jamie [D-MD-8], Rep. Garamendi, John [D-CA-3] Rep. Chu, Judy [D-CA-27], Rep. Green, Al [D-TX-9] Rep. Cleaver, Emanuel [D-MO-5], Rep. Shea-Porter, Carol [D-NH-1], Rep. Cicilline, David N. [D-RI-1], Rep. Ellison, Keith [D-MN-5], Rep. Napolitano, Grace F. [D-CA-32], Rep. Gonzalez, Vicente [D-TX-15], Rep. DeSaulnier, Mark [D-CA-11], Rep. Moore, Gwen [D-WI-4], Rep. Cohen, Steve [D-TN-9], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Thompson, Bennie G. [D-MS-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Bass, Karen [D-CA-37], Rep. Blumenauer, Earl [D-OR-3], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Higgins, Brian [D-NY-26], Rep. Jayapal, Pramila [D-WA-7], Rep. Khanna, Ro [D-CA-17], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Waters, Maxine [D-CA-43], Rep. Sarbanes, John P. [D-MD-3]
Rep. Levin, Sander M. [D-MI-9], Rep. Cummings, Elijah E. [D-MD-7], Rep. Lewis, John [D-GA-5], Rep. Pocan, Mark [D-WI-2] Rep. Raskin, Jamie [D-MD-8], Rep. Garamendi, John [D-CA-3] Rep. Chu, Judy [D-CA-27], Rep. Green, Al [D-TX-9] Rep. Cleaver, Emanuel [D-MO-5], Rep. Shea-Porter, Carol [D-NH-1], Rep. Cicilline, David N. [D-RI-1], Rep. Ellison, Keith [D-MN-5], Rep. Napolitano, Grace F. [D-CA-32], Rep. Gonzalez, Vicente [D-TX-15], Rep. DeSaulnier, Mark [D-CA-11], Rep. Moore, Gwen [D-WI-4], Rep. Cohen, Steve [D-TN-9], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Thompson, Bennie G. [D-MS-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Bass, Karen [D-CA-37]
-Energy and Commerce06/19/2018 Referred to the House Committee on Energy and CommerceBans health insurance issuers and group health plans from prohibiting pharmacy providers from providing certain information to enrollees.X
20
H.R.6144Know the Lowest Price Act of 2018Rep. Doggett, Lloyd [D-TX-35]06/19/201821
Rep. Bass, Karen [D-CA-37], Rep. Chu, Judy [D-CA-27], Rep. Cicilline, David N. [D-RI-1], Rep. Cleaver, Emanuel [D-MO-5], Rep. Cohen, Steve [D-TN-9], Rep. Cummings, Elijah E. [D-MD-7], Rep. DeSaulnier, Mark [D-CA-11], Rep. Doggett, Lloyd [D-TX-35], Rep. Ellison, Keith [D-MN-5], Rep. Garamendi, John [D-CA-3], Rep. Gonzalez, Vicente [D-TX-15], Rep. Green, Al [D-TX-9], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Levin, Sander M. [D-MI-9], Rep. Lewis, John [D-GA-5], Rep. Moore, Gwen [D-WI-4], Rep. Napolitano, Grace F. [D-CA-32], Rep. Pocan, Mark [D-WI-2], Rep. Raskin, Jamie [D-MD-8], Rep. Shea-Porter, Carol [D-NH-1], Rep. Thompson, Bennie G. [D-MS-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Blumenauer, Earl [D-OR-3], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Higgins, Brian [D-NY-26], Rep. Jayapal, Pramila [D-WA-7], Rep. Khanna, Ro [D-CA-17], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Waters, Maxine [D-CA-43], Rep. Sarbanes, John P. [D-MD-3]
Rep. Bass, Karen [D-CA-37], Rep. Chu, Judy [D-CA-27], Rep. Cicilline, David N. [D-RI-1], Rep. Cleaver, Emanuel [D-MO-5], Rep. Cohen, Steve [D-TN-9], Rep. Cummings, Elijah E. [D-MD-7], Rep. DeSaulnier, Mark [D-CA-11], Rep. Doggett, Lloyd [D-TX-35], Rep. Ellison, Keith [D-MN-5], Rep. Garamendi, John [D-CA-3], Rep. Gonzalez, Vicente [D-TX-15], Rep. Green, Al [D-TX-9], Rep. Gutierrez, Luis V. [D-IL-4], Rep. Levin, Sander M. [D-MI-9], Rep. Lewis, John [D-GA-5], Rep. Moore, Gwen [D-WI-4], Rep. Napolitano, Grace F. [D-CA-32], Rep. Pocan, Mark [D-WI-2], Rep. Raskin, Jamie [D-MD-8], Rep. Shea-Porter, Carol [D-NH-1], Rep. Thompson, Bennie G. [D-MS-2], Rep. Velazquez, Nydia M. [D-NY-7], Rep. Blumenauer, Earl [D-OR-3], Rep. Grijalva, Raul M. [D-AZ-3], Rep. Higgins, Brian [D-NY-26], Rep. Jayapal, Pramila [D-WA-7], Rep. Khanna, Ro [D-CA-17], Rep. Norton, Eleanor Holmes [D-DC-At Large], Rep. Waters, Maxine [D-CA-43], Rep. Sarbanes, John P. [D-MD-3]
-
Energy and Commerce, Ways and Means
06/27/2018 Referred to the Subcommittee on HealthAmends title XVIII of the Social Security Act to prohibit health plans and pharmacy benefit managers from restricting pharmacies from informing individuals regarding the prices for certain drugs and biologicals.XX
21
H.R.6264Restoring America's Leadership in Innovation Act of 2018Rep. Massie, Thomas [R-KY-4] 06/28/20182
Rep. Kaptur, Marcy [D-OH-9], Rep. Rohrabacher, Dana [R-CA-48]
Rep. Kaptur, Marcy [D-OH-9]
Rep. Rohrabacher, Dana [R-CA-48]
Judiciary06/28/2018 Referral to House Committee on the JudiciaryAbolish the inter partes review, Patent Trial and Appeal Board; overules Alice Corp. v. CLS Bank International; overules eBay v. MercExchange, and other XXX
22
H.R.6294REVAMP ActRep. Shimkus, John [R-IL-15]06/28/20182
Rep. Cardenas, Tony [D-CA-29], Rep. Eshoo, Anna G. [D-CA-18]
Rep. Cardenas, Tony [D-CA-29], Rep. Eshoo, Anna G. [D-CA-18]
-Energy and Commerce06/28/2018 Referral to House Committee on Energy and CommerceAmend the Federal Food, Drug, and Cosmetic Act to award a transferable exclusivity extension period for tge development of priority antimicrobial productsXX
23
H.R.6370Targeting Rogue and Opaque Letters Act of 2018Rep. Burgess, Michael C. [R-TX-26] 07/13/20182
Rep. Kaptur, Marcy [D-OH-9], Rep. Stivers, Steve [R-OH-15]
Rep. Kaptur, Marcy [D-OH-9]
Rep. Stivers, Steve [R-OH-15]
Energy and Commerce07/13/2018 Referral to House Committee on Energy and CommerceProvides that certain bad faith communications in connection with the assertion of a United States patent are unfair or deceptive acts or practices, and for other purposes.
24
H.R.6478Biosimilars Competition Act of 2018Rep. Sarbanes, John P. [D-MD-3]07/23/20181--
Rep. Johnson, Bill [R-OH-6]*
Energy and Commerce07/23/2018 Referred to the House Committee on Energy and CommerceIncrease the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes.X
25
H.R.6505Medicare Negotiation and Competitive Licensing Act of 2018Rep. Doggett, Lloyd [D-TX-35] 07/25/201885
Rep. Welch, Peter [D-VT-At Large]*, Rep. Cummings, Elijah E. [D-MD-7]*, Rep. Khanna, Ro [D-CA-17]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Adams, Alma S. [D-NC-12]*, Rep. Barragan, Nanette Diaz [D-CA-44]*, Rep. Bass, Karen [D-CA-37]*, Rep. Beatty, Joyce [D-OH-3]*, Rep. Blumenauer, Earl [D-OR-3]*, Rep. Bonamici, Suzanne [D-OR-1]*, Rep. Cartwright, Matt [D-PA-17]*, Rep. Castro, Joaquin [D-TX-20]*, Rep. Chu, Judy [D-CA-27]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Clarke, Yvette D. [D-NY-9]*, Rep. Cleaver, Emanuel [D-MO-5]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Crist, Charlie [D-FL-13]*, Rep. DeFazio, Peter A. [D-OR-4]*, Rep. DeSaulnier, Mark [D-CA-11]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Evans, Dwight [D-PA-2]*, Rep. Garamendi, John [D-CA-3]*, Rep. Gonzalez, Vicente [D-TX-15]*, Rep. Green, Al [D-TX-9]*, Rep. Gutierrez, Luis V. [D-IL-4]*, Rep. Hanabusa, Colleen [D-HI-1]*, Rep. Hastings, Alcee L. [D-FL-20]*, Rep. Higgins, Brian [D-NY-26]*, Rep. Jackson Lee, Sheila [D-TX-18]*, Rep. Jayapal, Pramila [D-WA-7]*, Rep. Johnson, Eddie Bernice [D-TX-30]*, Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4]*, Rep. Krishnamoorthi, Raja [D-IL-8]*, Rep. Langevin, James R. [D-RI-2]*, Rep. Lawson, Al, Jr. [D-FL-5]*, Rep. Lee, Barbara [D-CA-13]*, Rep. Levin, Sander M. [D-MI-9]*, Rep. Lewis, John [D-GA-5]*, Rep. Lowenthal, Alan S. [D-CA-47]*, Rep. Lujan Grisham, Michelle [D-NM-1]*, Rep. Maloney, Carolyn B. [D-NY-12]*, Rep. McCollum, Betty [D-MN-4]*, Rep. McNerney, Jerry [D-CA-9]*, Rep. Moore, Gwen [D-WI-4]*, Rep. Nadler, Jerrold [D-NY-10]*, Rep. Napolitano, Grace F. [D-CA-32]*, Rep. Nolan, Richard M. [D-MN-8]*, Rep. Norton, Eleanor Holmes [D-DC-At Large]*, Rep. Perlmutter, Ed [D-CO-7]*, Rep. Pingree, Chellie [D-ME-1]*, Rep. Raskin, Jamie [D-MD-8]*, Rep. Ruppersberger, C. A. Dutch [D-MD-2]*, Rep. Ryan, Tim [D-OH-13]*, Rep. Sarbanes, John P. [D-MD-3]*, Rep. Scott, Robert C. "Bobby" [D-VA-3]*, Rep. Shea-Porter, Carol [D-NH-1]*, Rep. Sherman, Brad [D-CA-30]*, Rep. Takano, Mark [D-CA-41]*, Rep. Thompson, Bennie G. [D-MS-2]*, Rep. Titus, Dina [D-NV-1]*, Rep. Vargas, Juan [D-CA-51]*, Rep. Veasey, Marc A. [D-TX-33]*, Rep. Velazquez, Nydia M. [D-NY-7]*, Rep. Visclosky, Peter J. [D-IN-1]*, Rep. Wasserman Schultz, Debbie [D-FL-23]*, Rep. Waters, Maxine [D-CA-43]*, Rep. Wilson, Frederica S. [D-FL-24]*, Rep. Espaillat, Adriano [D-NY-13]*, Rep. Peterson, Collin C. [D-MN-7]*, Rep. Davis, Danny K. [D-IL-7]*, Rep. Larson, John B. [D-CT-1]*, Rep. Serrano, Jose E. [D-NY-15]*, Rep. Jeffries, Hakeem S. [D-NY-8]*, Rep. Frankel, Lois [D-FL-21]*, Rep. Torres, Norma J. [D-CA-35], Rep. Maloney, Sean Patrick [D-NY-18], Rep. Dingell, Debbie [D-MI-12], Rep. Doyle, Michael F. [D-PA-14], Rep. Rush, Bobby L. [D-IL-1], Rep. Yarmuth, John A. [D-KY-3]
Rep. Welch, Peter [D-VT-At Large]*, Rep. Cummings, Elijah E. [D-MD-7]*, Rep. Khanna, Ro [D-CA-17]*, Rep. DeLauro, Rosa L. [D-CT-3]*, Rep. Schakowsky, Janice D. [D-IL-9]*, Rep. Kaptur, Marcy [D-OH-9]*, Rep. Pocan, Mark [D-WI-2]*, Rep. Grijalva, Raul M. [D-AZ-3]*, Rep. Adams, Alma S. [D-NC-12]*, Rep. Barragan, Nanette Diaz [D-CA-44]*, Rep. Bass, Karen [D-CA-37]*, Rep. Beatty, Joyce [D-OH-3]*, Rep. Blumenauer, Earl [D-OR-3]*, Rep. Bonamici, Suzanne [D-OR-1]*, Rep. Cartwright, Matt [D-PA-17]*, Rep. Castro, Joaquin [D-TX-20]*, Rep. Chu, Judy [D-CA-27]*, Rep. Cicilline, David N. [D-RI-1]*, Rep. Clarke, Yvette D. [D-NY-9]*, Rep. Cleaver, Emanuel [D-MO-5]*, Rep. Cohen, Steve [D-TN-9]*, Rep. Crist, Charlie [D-FL-13]*, Rep. DeFazio, Peter A. [D-OR-4]*, Rep. DeSaulnier, Mark [D-CA-11]*, Rep. Ellison, Keith [D-MN-5]*, Rep. Evans, Dwight [D-PA-2]*, Rep. Garamendi, John [D-CA-3]*, Rep. Gonzalez, Vicente [D-TX-15]*, Rep. Green, Al [D-TX-9]*, Rep. Gutierrez, Luis V. [D-IL-4]*, Rep. Hanabusa, Colleen [D-HI-1]*, Rep. Hastings, Alcee L. [D-FL-20]*, Rep. Higgins, Brian [D-NY-26]*, Rep. Jackson Lee, Sheila [D-TX-18]*, Rep. Jayapal, Pramila [D-WA-7]*, Rep. Johnson, Eddie Bernice [D-TX-30]*, Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4]*, Rep. Krishnamoorthi, Raja [D-IL-8]*, Rep. Langevin, James R. [D-RI-2]*, Rep. Lawson, Al, Jr. [D-FL-5]*, Rep. Lee, Barbara [D-CA-13]*, Rep. Levin, Sander M. [D-MI-9]*, Rep. Lewis, John [D-GA-5]*, Rep. Lowenthal, Alan S. [D-CA-47]*, Rep. Lujan Grisham, Michelle [D-NM-1]*, Rep. Maloney, Carolyn B. [D-NY-12]*, Rep. McCollum, Betty [D-MN-4]*, Rep. McNerney, Jerry [D-CA-9]*, Rep. Moore, Gwen [D-WI-4]*, Rep. Nadler, Jerrold [D-NY-10]*, Rep. Napolitano, Grace F. [D-CA-32]*, Rep. Nolan, Richard M. [D-MN-8]*, Rep. Norton, Eleanor Holmes [D-DC-At Large]*, Rep. Perlmutter, Ed [D-CO-7]*, Rep. Pingree, Chellie [D-ME-1]*, Rep. Raskin, Jamie [D-MD-8]*, Rep. Ruppersberger, C. A. Dutch [D-MD-2]*, Rep. Ryan, Tim [D-OH-13]*, Rep. Sarbanes, John P. [D-MD-3]*, Rep. Scott, Robert C. "Bobby" [D-VA-3]*, Rep. Shea-Porter, Carol [D-NH-1]*, Rep. Sherman, Brad [D-CA-30]*, Rep. Takano, Mark [D-CA-41]*, Rep. Thompson, Bennie G. [D-MS-2]*, Rep. Titus, Dina [D-NV-1]*, Rep. Vargas, Juan [D-CA-51]*, Rep. Veasey, Marc A. [D-TX-33]*, Rep. Velazquez, Nydia M. [D-NY-7]*, Rep. Visclosky, Peter J. [D-IN-1]*, Rep. Wasserman Schultz, Debbie [D-FL-23]*, Rep. Waters, Maxine [D-CA-43]*, Rep. Wilson, Frederica S. [D-FL-24]*, Rep. Espaillat, Adriano [D-NY-13]*, Rep. Peterson, Collin C. [D-MN-7]*, Rep. Davis, Danny K. [D-IL-7]*, Rep. Larson, John B. [D-CT-1]*, Rep. Serrano, Jose E. [D-NY-15]*, Rep. Jeffries, Hakeem S. [D-NY-8]*, Rep. Frankel, Lois [D-FL-21]*, Rep. Torres, Norma J. [D-CA-35], Rep. Maloney, Sean Patrick [D-NY-18], Rep. Dingell, Debbie [D-MI-12], Rep. Doyle, Michael F. [D-PA-14], Rep. Rush, Bobby L. [D-IL-1], Rep. Yarmuth, John A. [D-KY-3]
-
Energy and Commerce, Ways and Means
07/25/2018 Referral to Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.Amends title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program, and issue compulsory licenses if negotiation failsXX
26
H.R.6557Inventor Protection ActRep. Rohrabacher, Dana [R-CA-48] 07/26/20180---Judiciary07/26/2018 Referral to House Committee on the JudiciaryUndermine the inter partes review, Patent Trial and Appeal Board; overules eBay v. MercExchange, and other XX
27
H.R.6574Medicare Fair Drug Pricing Act of 2018Rep. Schakowsky, Janice D. [D-IL-9] 07/26/20180---
Energy and Commerce, Ways and Means
07/26/2018 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.Amends part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to determine, on behalf of Medicare beneficiaries, covered part D drug prices for certain covered part D drugs, and for other purposes.X
28
H.R.6575Medicare Prescription Drug Savings and Choice Act of 2018Rep. Schakowsky, Janice D. [D-IL-9]07/26/20180---
Energy and Commerce, Ways and Means
07/26/2018 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.Amends part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to enter into negotiations in accordance with subsection (b) with pharmaceutical manufacturers to reduce the purchase cost of covered part D drugs for eligible part D individuals who enroll in such a planX
29
H.R.6576Drug-Price Transparency in Communications ActRep. Schakowsky, Janice D. [D-IL-9] 07/26/20180---Energy and Commerce07/26/2018 Referral to House Committee on Energy and CommerceRequires drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drugX
30
H.R.6562FORWARD Act of 2018Rep. McCarthy, Kevin [R-CA-2307/26/201813Energy and Commerce07/26/2018 Introduced in HouseX
31
H.R.6577 PRICED ActRep. Schakowsky, Janice D. [D-IL-9]07/26/20180---Energy and Commerce07/26/2018 Introduced in HouseTo amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.X
32
H.R.7348Affordable Drug Manufacturing Act of 2018Rep. Schakowsky, Janice D. [D-IL-9]12/19/20180---Energy and Commerce12/19/2018 Introduced in HouseTo establish an office to be known as the Office of Drug Manufacturing.
33
34
======================Senate Bills ========================================================================================================================================
35
36
S.41Medicare Prescription Drug Price Negotiation Act of 2017Sen. Klobuchar, Amy [D-MN] 01/05/201713
Sen. Blumenthal, Richard [D-CT]*, Sen. Shaheen, Jeanne [D-NH]*, Sen. Baldwin, Tammy [D-WI]*, Sen. King, Angus S., Jr. [I-ME]*, Sen. Brown, Sherrod [D-OH]*, Sen. Leahy, Patrick J. [D-VT]*, Sen. Franken, Al [D-MN]*, Sen. Kaine, Tim [D-VA]*, Sen. Hassan, Margaret Wood [D-NH], Sen. Booker, Cory A. [D-NJ], Sen. Murphy, Christopher [D-CT], Sen. Harris, Kamala D. [D-CA], Sen. Cantwell, Maria [D-WA]
Sen. Blumenthal, Richard [D-CT]*, Sen. Shaheen, Jeanne [D-NH]*, Sen. Baldwin, Tammy [D-WI]*, Sen. Brown, Sherrod [D-OH]*, Sen. Leahy, Patrick J. [D-VT]*, Sen. Franken, Al [D-MN]*, Sen. Kaine, Tim [D-VA]*, Sen. Hassan, Margaret Wood [D-NH], Sen. Booker, Cory A. [D-NJ], Sen. Murphy, Christopher [D-CT], Sen. Harris, Kamala D. [D-CA], Sen. Cantwell, Maria [D-WA]
-Finance01/05/2017 Referral to Committee on FinanceAmends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to negotiate with pharmaceutical companies regarding prices for drugs covered under the Medicare prescription drug benefit. Current law prohibits CMS from doing so.X
37
S.64Safe and Affordable Drugs from Canada Act of 2017Sen. McCain, John [R-AZ]01/09/20170---
Health, Education, Labor, and Pensions
01/09/2017 Introduced in SenateAmends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacyX
38
S.92Safe and Affordable Drugs from Canada Act of 2017Sen. McCain, John [R-AZ]01/10/201710
Sen. Klobuchar, Amy [D-MN]*, Sen. Leahy, Patrick J. [D-VT], Sen. Whitehouse, Sheldon [D-RI], Sen. Brown, Sherrod [D-OH], Sen. Baldwin, Tammy [D-WI], Sen. Shaheen, Jeanne [D-NH], Sen. Merkley, Jeff [D-OR], Sen. Hassan, Margaret Wood [D-NH], Sen. Grassley, Chuck [R-IA], Sen. King, Angus S., Jr. [I-ME]
Sen. Klobuchar, Amy [D-MN]*, Sen. Leahy, Patrick J. [D-VT], Sen. Whitehouse, Sheldon [D-RI], Sen. Brown, Sherrod [D-OH], Sen. Baldwin, Tammy [D-WI], Sen. Shaheen, Jeanne [D-NH], Sen. Merkley, Jeff [D-OR], Sen. Hassan, Margaret Wood [D-NH]
Sen. Grassley, Chuck [R-IA]
Health, Education, Labor, and Pensions
01/10/2017 Introduced in SenateAmends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 185 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy thatX
39
S.124Preserve Access to Affordable Generics ActSen. Klobuchar, Amy [D-MN] 01/12/20171Sen. Grassley, Chuck [R-IA]-
Sen. Grassley, Chuck [R-IA]
Judiciary01/12/2017 Referral to Committee on the JudiciaryAmends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and is a violation of this bill if the filer of the abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug. An agreement is exempted if the only consideration granted to the generic manufacturer is: (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug infringes a patent. An entity subject to an FTC enforcement order may petition for the order be reviewed in federal court. Civil penalties are imposed for violations of this bill. This bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug. This bill amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for a generic drug if the FTC or a court decides that an agreement violated this bill. The FTC is granted exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic drugs. The FTC may not commence enforcement actions (other than cease and desist requests) more than six years after the FTC is notified of an agreement. XX
40
S.183Short on Competition ActSen. Klobuchar, Amy [D-MN] 01/20/20173
Sen. Lee, Mike [R-UT], Sen. Durbin, Richard J. [D-IL], Sen. Grassley, Chuck [R-IA]
Sen. Durbin, Richard J. [D-IL]
Sen. Lee, Mike [R-UT], Sen. Grassley, Chuck [R-IA]
Health, Education, Labor, and Pensions
01/20/2017 Referral to Committee on Health, Education, Labor, and PensionsAmends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness. Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited inspections and review. A drug is in a noncompetitive market if: (1) there are fewer than five holders of approved applications for commercially available brand name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) patents on the active ingredient of the drug have expired.X
41
S.297Increasing Competition in Pharmaceuticals ActSen. Collins, Susan M. [R-ME]02/02/20172
Sen. McCaskill, Claire [D-MO], Sen. Tester, Jon [D-MT]
Sen. McCaskill, Claire [D-MO], Sen. Tester, Jon [D-MT]
-
Health, Education, Labor, and Pensions
02/02/2017 Referral to Committee on Health, Education, Labor, and PensionsAmends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 150 days. User fees are waived for such an application unless the drug is under patent. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. The FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application upon approval. A voucher may be used to have the FDA review and take action upon a generic drug application within 150 days of submission. The FDA may revoke a voucher awarded for a drug that is not marketed within one year of approval. This voucher program is terminated at the end of FY2022. The FDA must periodically report on generic drug applications filed before FY2016 that are still pending. For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.X
42
S.348Prescription Drug and Health Improvement Act of 2017Sen. Franken, Al [D-MN]02/09/20173
Sen. Reed, Jack [D-RI]*, Sen. Brown, Sherrod [D-OH]*, Sen. Gillibrand, Kirsten E. [D-NY]
Sen. Reed, Jack [D-RI]*, Sen. Brown, Sherrod [D-OH]*, Sen. Gillibrand, Kirsten E. [D-NY]
-Finance02/09/2017 Introduced in SenateRequires the Centers for Medicare & Medicaid Services (CMS) to negotiate lower prices on behalf of Medicare and Medicare Advantage (MA) beneficiaries for covered prescription drugs that the CMS deems appropriate for negotiation based on: (1) program and per-beneficiary spending, (2) unit price increases over the preceding years, (3) initial launch price, (4) availability of similarly effective alternative treatments, (5) status of the drug as a follow-on to previously approved drugs, and (6) any other criteria determined by the CMS. If, after a one year period, negotiations with respect to a covered prescription drug prove unsuccessful, the CMS shall establish a price for the drug that is equal to the lesser of the price paid by the Department of Veterans Affairs or the price paid by the four largest federal pharmaceutical-drug purchasers. The CMS may (but is not required to) negotiate lower prices on behalf of Medicare and MA beneficiaries for other covered prescription drugs. The Government Accountability Office must report to Congress on the CMS' negotiations. The Center for Medicare and Medicaid Innovation must test several specified models for negotiating drug and biological prices.X
43
S.469Affordable and Safe Prescription Drug Importation ActSen. Sanders, Bernard [I-VT] 02/28/201721
Sen. Booker, Cory A. [D-NJ]*, Sen. Casey, Robert P., Jr. [D-PA]*, Sen. Heinrich, Martin [D-NM]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Brown, Sherrod [D-OH]*, Sen. Reed, Jack [D-RI]*, Sen. Franken, Al [D-MN]*, Sen. Baldwin, Tammy [D-WI]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Udall, Tom [D-NM]*, Sen. Stabenow, Debbie [D-MI]*, Sen. Shaheen, Jeanne [D-NH]*, Sen. Cantwell, Maria [D-WA]*, Sen. Van Hollen, Chris [D-MD]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Manchin, Joe, III [D-WV]*, Sen. Merkley, Jeff [D-OR], Sen. Warren, Elizabeth [D-MA], Sen. King, Angus S., Jr. [I-ME]*
Sen. Booker, Cory A. [D-NJ]*, Sen. Casey, Robert P., Jr. [D-PA]*, Sen. Heinrich, Martin [D-NM]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Brown, Sherrod [D-OH]*, Sen. Reed, Jack [D-RI]*, Sen. Franken, Al [D-MN]*, Sen. Baldwin, Tammy [D-WI]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Udall, Tom [D-NM]*, Sen. Stabenow, Debbie [D-MI]*, Sen. Shaheen, Jeanne [D-NH]*, Sen. Cantwell, Maria [D-WA]*, Sen. Van Hollen, Chris [D-MD]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Manchin, Joe, III [D-WV]*, Sen. Merkley, Jeff [D-OR], Sen. Warren, Elizabeth [D-MA]
-
Health, Education, Labor, and Pensions
02/28/2017 Introduced in SenateAmends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals.X
44
S.495Medical Innovation Prize Fund ActSen. Sanders, Bernard [I-VT]03/02/20170---
Health, Education, Labor, and Pensions
03/02/2017 Referral to Committee on Health, Education, Labor, and PensionsEstablishes the Fund for Medical Innovation Prizes to provide for prize payments in lieu of market exclusivity. The Board of Trustees of the fund must award prize payments to: (1) the first person to receive approval for a medication; (2) the holder of the patent for a manufacturing process; and (3) persons or communities that contributed to the development of a rewarded medication or process through the open, nondiscriminatory, and royalty-free sharing of knowledge, data, materials, and technology. The board must establish: (1) criteria for selecting recipients and determining the amount of prizes, and (2) independent expert advisory committees to assist it in carrying out this bill. The board must establish, and may periodically modify, minimum levels of funding for priority research and development, including research and development regarding global neglected diseases, orphan diseases, global infectious diseases, and other global public health priorities. The board may authorize nonprofit intermediaries to reward projects for interim research and development of products or for open source dividend prizes. The Government Accountability Office must determine the board's effectiveness in bringing to market new medications and manufacturing processes in a cost-effective manner and in addressing society's medical needs. The bill establishes an annual fee on health insurers to fund this bill.X
45
S.637Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017Sen. Wyden, Ron [D-OR] 03/15/20173
Sen. Brown, Sherrod [D-OH]*, Sen. Heitkamp, Heidi [D-ND]*, Sen. Tester, Jon [D-MT]
Sen. Brown, Sherrod [D-OH]*, Sen. Heitkamp, Heidi [D-ND]*, Sen. Tester, Jon [D-MT]
-Finance03/15/2017 Introduced in SenateAmends title XI (General Provisions) of the Social Security Act (SSAct) to require the public disclosure of certain information provided to the Department of Health and Human Services (HHS) by a pharmacy benefit manager (PBM) that contracts with: (1) a prescription drug plan (PDP) under Medicare or Medicare Advantage (MA), or (2) a qualified health benefits plan offered through an exchange established under the Patient Protection and Affordable Care Act. Specifically, HHS must publish on its website, with respect to each PBM, information regarding: (1) the amount and type of rebates and discounts negotiated by the PBM and the extent to which these rebates and discounts are passed on to the plan sponsor, and (2) the difference between the amount paid by the plan sponsor to the PBM and the amount paid by the PBM to pharmacies. As a condition of participation as a contractor under Medicare or MA, a PBM must pass on to a PDP sponsor a minimum percentage, as established by HHS, of the amount of rebates and discounts negotiated by the PBM that are attributable to patient utilization under the plan. The bill also amends title XVIII (Medicare) of the SSAct to modify requirements regarding enrollees' access to negotiated drug prices. Current law requires a PDP sponsor to provide enrollees in Medicare or MA with access to negotiated drug prices that account for rebates and discounts. The bill requires that, with respect to a covered drug, a negotiated price (or, if necessary, an approximate negotiated price) be provided at the point of sale.XX
46
S.771Improving Access To Affordable Prescription Drugs ActSen. Franken, Al [D-MN]03/29/201715
Sen. Sanders, Bernard [I-VT]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Brown, Sherrod [D-OH]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Baldwin, Tammy [D-WI]*, Sen. Reed, Jack [D-RI]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Durbin, Richard J. [D-IL]*, Sen. Van Hollen, Chris [D-MD]*, Sen. Merkley, Jeff [D-OR]*, Sen. Udall, Tom [D-NM]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Booker, Cory A. [D-NJ]*
Sen. Whitehouse, Sheldon [D-RI]*, Sen. Brown, Sherrod [D-OH]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Baldwin, Tammy [D-WI]*, Sen. Reed, Jack [D-RI]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Durbin, Richard J. [D-IL]*, Sen. Van Hollen, Chris [D-MD]*, Sen. Merkley, Jeff [D-OR]*, Sen. Udall, Tom [D-NM]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Booker, Cory A. [D-NJ]*
-Finance03/29/2017 Referral to Committee on FinanceAmends provisions of various laws relating to prescription-drug pricing and affordability. Specifically, the bill: expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures; requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under the Medicare program; requires the GAO to report to Congress on such negotiations conducted by the CMS; requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models for negotiating drug prices; establishes reporting requirements, and corresponding civil penalties for noncompliance, for pharmaceutical companies with respect to spikes in prescription-drug prices; establishes an excise tax on prescription drugs subject to price spikes; lessens prescription-drug cost-sharing requirements under qualified health plans, group health plans, and the Medicare program; modifies provisions related to the importation of prescription drugs; requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program; establishes a prize fund for new and more effective treatments of bacterial infections; establishes a Center for Clinical Research within the National Institutes of Health; modifies provisions related to drug exclusivity; allows the Federal Trade Commission to initiate enforcement proceedings against parties to an agreement resolving or settling a patent-infringement claim in connection with the sale of a drug product; requires the Food and Drug Administration to establish a database of generic drugs; and modifies other provisions related to generic drugs, prescription-drug advertising, and product hopping.XXXXXXXXXXX
47
S.974CREATES Act of 2017Sen. Leahy, Patrick J. [D-VT] 04/27/201730
Sen. Grassley, Chuck [R-IA]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Lee, Mike [R-UT]*, Sen. Feinstein, Dianne [D-CA]*, Sen. McCaskill, Claire [D-MO]*, Sen. Collins, Susan M. [R-ME]*, Sen. McCain, John [R-AZ]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Cotton, Tom [R-AR]*, Sen. Durbin, Richard J. [D-IL]*, Sen. Cruz, Ted [R-TX], Sen. Paul, Rand [R-KY], Sen. Hassan, Margaret Wood [D-NH], Sen. Kennedy, John [R-LA], Sen. Smith, Tina [D-MN], Sen. Murkowski, Lisa [R-AK], Sen. Baldwin, Tammy [D-WI], Sen. Daines, Steve [R-MT], Sen. King, Angus S., Jr. [I-ME], Sen. Graham, Lindsey [R-SC], Sen. Brown, Sherrod [D-OH], Sen. Young, Todd C. [R-IN], Sen. Stabenow, Debbie [D-MI], Sen. Rounds, Mike [R-SD], Sen. Tester, Jon [D-MT], Sen. Ernst, Joni [R-IA], Sen. Menendez, Robert [D-NJ], Sen. Booker, Cory A. [D-NJ], Sen. Fischer, Deb [R-NE]
Sen. Klobuchar, Amy [D-MN]*, Sen. Feinstein, Dianne [D-CA]*, Sen. McCaskill, Claire [D-MO]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Durbin, Richard J. [D-IL]*, Sen. Hassan, Margaret Wood [D-NH], Sen. Stabenow, Debbie [D-MI], Sen. Baldwin, Tammy [D-WI], Sen. Smith, Tina [D-MN], Sen. Brown, Sherrod [D-OH], Sen. Tester, Jon [D-MT], Sen. Menendez, Robert [D-NJ], Sen. Booker, Cory A. [D-NJ]
Sen. Grassley, Chuck [R-IA]*, Sen. Lee, Mike [R-UT]*, Sen. Collins, Susan M. [R-ME]*, Sen. McCain, John [R-AZ]*, Sen. Cotton, Tom [R-AR]*, Sen. Cruz, Ted [R-TX], Sen. Paul, Rand [R-KY], Sen. Kennedy, John [R-LA], Sen. Murkowski, Lisa [R-AK], Sen. Daines, Steve [R-MT], Sen. Graham, Lindsey [R-SC], Sen. Young, Todd C. [R-IN], Sen. Rounds, Mike [R-SD], Sen. Ernst, Joni [R-IA], Sen. Fischer, Deb [R-NE]
Judiciary06/21/2018 Placed on Senate Legislative Calendar under General Orders. Calendar No. 482Promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological productsXX
48
S.1115Making Pharmaceutical Markets More Competitive ActSen. Collins, Susan M. [R-ME]05/11/20173
Sen. McCaskill, Claire [D-MO], Sen. Cotton, Tom [R-AR], Sen. Franken, Al [D-MN]
Sen. McCaskill, Claire [D-MO], Sen. Franken, Al [D-MN]
Sen. Cotton, Tom [R-AR]
Health, Education, Labor, and Pensions
05/11/2017 Referral to Committee on Health, Education, Labor, and PensionsAmends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to prioritize the review of generic drug applications and supplements with respect to drugs that are in a shortage or for which there are not more than three approved drugs. The holder of an approved drug application must notify the FDA within 180 days of withdrawing or transferring the application or withdrawing the drug from sale. The FDA must maintain a list of generic drugs with three or fewer holders of approved applications.X
49
S.1131Fair Accountability and Innovative Research Drug Pricing Act of 2017Sen. Baldwin, Tammy [D-WI]05/16/20171Sen. McCain, John [R-AZ]-
Sen. McCain, John [R-AZ]
Health, Education, Labor, and Pensions
05/16/2017 Referral to Committee on Health, Education, Labor, and Pensions.Amends the Public Health Service Act to require manufacturers of certain drugs and biological products with a wholesale cost of $100 or more per month to report to the Department of Health and Human Services (HHS) price increases that result in a 10% or more increase in the cost of a drug over a 12-month period or a 25% or more increase over a 36-month period. Reports are required for prescription drugs and drugs commonly administered in hospitals, except vaccines, drugs for rare conditions, and drugs with annual sales for Medicare and Medicaid enrollees of less than $1. Reports must contain specified information including pricing history and a justification for each price increase in the relevant period. Manufacturers that do not submit a required report are subject to a civil penalty. Collected penalty funds must be used to carry out activities related to this reporting requirement and to improve consumer and provider information about drug value and drug price transparency. HHS must publish manufacturer reports, a summary of those reports, and supporting analyses.XX
50
S.1348Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017Sen. Wyden, Ron [D-OR] 06/13/20179
Sen. Cardin, Benjamin L. [D-MD]*, Sen. Stabenow, Debbie [D-MI]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Carper, Thomas R. [D-DE]*, Sen. Coons, Christopher A. [D-DE]*, Sen. Tester, Jon [D-MT], Sen. Duckworth, Tammy [D-IL], Sen. Menendez, Robert [D-NJ], Sen. Heitkamp, Heidi [D-ND]
Sen. Cardin, Benjamin L. [D-MD]*, Sen. Stabenow, Debbie [D-MI]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Carper, Thomas R. [D-DE]*, Sen. Coons, Christopher A. [D-DE]*, Sen. Tester, Jon [D-MT], Sen. Duckworth, Tammy [D-IL], Sen. Menendez, Robert [D-NJ], Sen. Heitkamp, Heidi [D-ND]
-Finance06/13/2017 Referral to Committee on FinanceAmends title XI (General Provisions) of the Social Security Act to require manufacturers of drugs with specified percentage increases in their wholesale costs to submit to the Centers for Medicare & Medicaid Services (CMS) written justification for certain increases in drug prices. The CMS shall publish each submission, together with an easily understandable summary, on its website. Certain proprietary information may be excluded from publication, as specified by the bill. A manufacturer that does not comply with the bill's requirements shall be subject to civil monetary penalties.XXX
51
S.1390STRONGER Patents Act of 2017Sen. Coons, Christopher A. [D-DE]06/21/20173
Sen. Cotton, Tom [R-AR], Sen. Durbin, Richard J. [D-IL], Sen. Hirono, Mazie K. [D-HI]
Sen. Durbin, Richard J. [D-IL], Sen. Hirono, Mazie K. [D-HI]
Sen. Cotton, Tom [R-AR]
Judiciary04/18/2018 Committee on the Judiciary. Hearings heldAmends the inter partes review, post-grant review process; overules eBay v. MercExchange, and other XX
52
S.1509Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017Sen. Hatch, Orrin G. [R-UT] 06/29/20174
Sen. Menendez, Robert [D-NJ], Sen. Scott, Tim [R-SC], Sen. Nelson, Bill [D-FL], Sen. Rubio, Marco [R-FL], Sen. Donnelly, Joe [D-IN]
Sen. Menendez, Robert [D-NJ], Sen. Nelson, Bill [D-FL], Sen. Donnelly, Joe [D-IN]
Sen. Scott, Tim [R-SC], Sen. Rubio, Marco [R-FL]
Health, Education, Labor, and Pensions
06/29/2017 Referral to Committee on Health, Education, Labor, and PensionsAmends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). The FDA may revoke an extension if the application for the new indication contained an untrue material statement. The FDA must notify the public of products that receive this extension and patents related to those products. Products may receive only one of these extensions. This extension is in addition to other extensions. Only products approved after enactment of this bill for a new indication that is a rare disease or condition are eligible for an extension. For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication. The bill expands to cover brand name drugs provisions that allow generic drugs to be approved and marketed without labeling for pediatric indications when the pediatric indications are protected by patent or marketing exclusivity.X
53
S.1681A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.Sen. Sanders, Bernard [I-VT] 07/31/20170---
Health, Education, Labor, and Pensions
07/31/2017 Referral to Committee on Health, Education, Labor, and PensionsRequires persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.X
54
S.1688Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017Sen. Klobuchar, Amy [D-MN] 08/01/201735
Sen. Baldwin, Tammy [D-WI]*, Sen. Bennet, Michael F. [D-CO]* Sen. Blumenthal, Richard [D-CT]*, Sen. Booker, Cory A. [D-NJ]* Sen. Brown, Sherrod [D-OH]*, Sen. Cantwell, Maria [D-WA]*, Sen. Cardin, Benjamin L. [D-MD]*, Sen. Duckworth, Tammy [D-IL]*, Sen. Franken, Al [D-MN]*, Sen. Harris, Kamala D. [D-CA]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Heinrich, Martin [D-NM]*, Sen. Hirono, Mazie K. [D-HI]*, Sen. Kaine, Tim [D-VA]*, Sen. King, Angus S., Jr. [I-ME]*, Sen. Leahy, Patrick J. [D-VT]*, Sen. Manchin, Joe, III [D-WV]*, Sen. McCaskill, Claire [D-MO]*, Sen. Merkley, Jeff [D-OR]*, Sen. Murphy, Christopher [D-CT]*, Sen. Murray, Patty [D-WA]*, Sen. Nelson, Bill [D-FL]*, Sen. Schumer, Charles E. [D-NY]*, Sen. Shaheen, Jeanne [D-NH]*, Sen. Stabenow, Debbie [D-MI]*, Sen. Udall, Tom [D-NM]*, Sen. Van Hollen, Chris [D-MD]*, Sen. Warner, Mark R. [D-VA]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Wyden, Ron [D-OR]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Reed, Jack [D-RI], Sen. Cortez Masto, Catherine [D-NV], Sen. Smith, Tina [D-MN]
Sen. Baldwin, Tammy [D-WI]*, Sen. Bennet, Michael F. [D-CO]* Sen. Blumenthal, Richard [D-CT]*, Sen. Booker, Cory A. [D-NJ]* Sen. Brown, Sherrod [D-OH]*, Sen. Cantwell, Maria [D-WA]*, Sen. Cardin, Benjamin L. [D-MD]*, Sen. Duckworth, Tammy [D-IL]*, Sen. Franken, Al [D-MN]*, Sen. Harris, Kamala D. [D-CA]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Heinrich, Martin [D-NM]*, Sen. Hirono, Mazie K. [D-HI]*, Sen. Kaine, Tim [D-VA]*, Sen. Leahy, Patrick J. [D-VT]*, Sen. Manchin, Joe, III [D-WV]*, Sen. McCaskill, Claire [D-MO]*, Sen. Merkley, Jeff [D-OR]*, Sen. Murphy, Christopher [D-CT]*, Sen. Murray, Patty [D-WA]*, Sen. Nelson, Bill [D-FL]*, Sen. Schumer, Charles E. [D-NY]*, Sen. Shaheen, Jeanne [D-NH]*, Sen. Stabenow, Debbie [D-MI]*, Sen. Udall, Tom [D-NM]*, Sen. Van Hollen, Chris [D-MD]*, Sen. Warner, Mark R. [D-VA]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Wyden, Ron [D-OR]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Whitehouse, Sheldon [D-RI]*, Sen. Reed, Jack [D-RI], Sen. Cortez Masto, Catherine [D-NV], Sen. Smith, Tina [D-MN]
-Finance08/01/2017 Referral to Committee on FinanceAmends title XVIII (Medicare) of the Social Security Act to allow the Centers for Medicare & Medicaid Services to: (1) negotiate drug prices under the Medicare prescription drug benefit, and (2) institute a price structure for the reimbursement of drugs covered under the benefit.X
55
S.1948A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents.Sen. McCaskill, Claire [D-MO]10/05/20170---Indian Affairs10/05/2017 Referral to Committee on Indian AffairsProhibits an Indian tribe from asserting sovereign immunity as a defense in an inter partes review of the validity of a patent.X
56
S.2011Medicare Drug Price Negotiation ActSen. Sanders, Bernard [I-VT]10/25/20177
Sen. Reed, Jack [D-RI]*, Sen. Leahy, Patrick J. [D-VT]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Harris, Kamala D. [D-CA]*, Sen. Franken, Al [D-MN]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Blumenthal, Richard [D-CT]
Sen. Reed, Jack [D-RI]*, Sen. Leahy, Patrick J. [D-VT]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Harris, Kamala D. [D-CA]*, Sen. Franken, Al [D-MN]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Blumenthal, Richard [D-CT]
-Finance10/25/2017 Introduced in SenateAmends title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes.X
57
S.2157Drug-Price Transparency in Communications ActSen. Durbin, Richard J. [D-IL] 11/16/20177
Sen. Brown, Sherrod [D-OH]*, Sen. Franken, Al [D-MN]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Harris, Kamala D. [D-CA]*, Sen. Gillibrand, Kirsten E. [D-NY], Sen. Blumenthal, Richard [D-CT], Sen. King, Angus S., Jr. [I-ME]*
Sen. Brown, Sherrod [D-OH]*, Sen. Franken, Al [D-MN]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Harris, Kamala D. [D-CA]*, Sen. Gillibrand, Kirsten E. [D-NY], Sen. Blumenthal, Richard [D-CT]
-
Health, Education, Labor, and Pensions
11/16/2017 Introduced in Senate
Require drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug.X
58
S.2476Expanding Access to Low Cost Generic Drugs ActSen. Smith, Tina [D-MN]02/28/20180---
Health, Education, Labor, and Pensions
02/28/2018 Referral to Committee on Health, Education, Labor, and PensionsAmends the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market.XX
59
S.2469STAAR ActSen. Brown, Sherrod [D-OH]02/28/20181Sen. King, Angus S., Jr. [I-ME]--
Health, Education, Labor, and Pensions
02/28/2018 Introduced in Senate
X
60
S.2514PACED ActSen. Cotton, Tom [R-AR]03/07/20184
Sen. McCaskill, Claire [D-MO], Sen. Perdue, David [R-GA], Sen. Ernst, Joni [R-IA], Sen. Toomey, Pat [R-PA]
Sen. McCaskill, Claire [D-MO]
Sen. Perdue, David [R-GA], Sen. Ernst, Joni [R-IA], Sen. Toomey, Pat [R-PA]
Judiciary03/07/2018 Referral to Committee on the JudiciaryAmends title 35, United States Code, to provide that a patent owner may not assert sovereign immunity as a defense in certain actions before the United States Patent and Trademark Office, and for other purposes.X
61
S.2553Know the Lowest Price Act of 2018Sen. Stabenow, Debbie [D-MI]03/14/201813
Sen. Brown, Sherrod [D-OH], Sen. Donnelly, Joe [D-IN], Sen. McCaskill, Claire [D-MO]*, Sen. Menendez, Robert [D-NJ], Sen. Van Hollen, Chris [D-MD], Sen. Wyden, Ron [D-OR]*, Sen. Barrasso, John [R-WY]*, Sen. Cassidy, Bill [R-LA]*, Sen. Collins, Susan M. [R-ME]*, Sen. Fischer, Deb [R-NE], Sen. Heller, Dean [R-NV], Sen. Paul, Rand [R-KY], Sen. Portman, Rob [R-OH]
Sen. Brown, Sherrod [D-OH], Sen. Donnelly, Joe [D-IN], Sen. McCaskill, Claire [D-MO]*, Sen. Menendez, Robert [D-NJ], Sen. Van Hollen, Chris [D-MD], Sen. Wyden, Ron [D-OR]*
Sen. Barrasso, John [R-WY]*, Sen. Cassidy, Bill [R-LA]*, Sen. Collins, Susan M. [R-ME]*, Sen. Fischer, Deb [R-NE], Sen. Heller, Dean [R-NV], Sen. Paul, Rand [R-KY], Sen. Portman, Rob [R-OH]
Finance
09/04/2018 Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Unanimous Consent.
Prohibits a health-benefits plan or pharmacy-benefits manager under Medicare or Medicare Advantage from restricting a pharmacy from informing an enrollee of any difference between the price of a drug under the plan and the price of the drug without health-insurance coverage.XX
62
S.2554Patient Right to Know Drug Prices ActSen. Collins, Susan M. [R-ME]03/14/201818
Sen. Baldwin, Tammy [D-WI], Sen. Blumenthal, Richard [D-CT], Sen. Donnelly, Joe [D-IN], Sen. Feinstein, Dianne [D-CA], Sen. Hassan, Margaret Wood [D-NH], Sen. Heitkamp, Heidi [D-ND], Sen. McCaskill, Claire [D-MO]*, Sen. Menendez, Robert [D-NJ], Sen. Smith, Tina [D-MN], Sen. Stabenow, Debbie [D-MI]*, Sen. Alexander, Lamar [R-TN], Sen. Barrasso, John [R-WY]*, Sen. Capito, Shelley Moore [R-WV], Sen. Cassidy, Bill [R-LA]*, Sen. Fischer, Deb [R-NE], Sen. Kennedy, John [R-LA], Sen. Murkowski, Lisa [R-AK], Sen. Wicker, Roger F. [R-MS], Sen. Boozman, John [R-AR], Sen. King, Angus S., Jr. [I-ME]
Sen. Baldwin, Tammy [D-WI], Sen. Blumenthal, Richard [D-CT], Sen. Donnelly, Joe [D-IN], Sen. Feinstein, Dianne [D-CA], Sen. Hassan, Margaret Wood [D-NH], Sen. Heitkamp, Heidi [D-ND], Sen. McCaskill, Claire [D-MO]*, Sen. Menendez, Robert [D-NJ], Sen. Smith, Tina [D-MN], Sen. Stabenow, Debbie [D-MI]*
Sen. Alexander, Lamar [R-TN], Sen. Barrasso, John [R-WY]*, Sen. Capito, Shelley Moore [R-WV], Sen. Cassidy, Bill [R-LA]*, Sen. Fischer, Deb [R-NE], Sen. Kennedy, John [R-LA], Sen. Murkowski, Lisa [R-AK], Sen. Wicker, Roger F. [R-MS], Sen. Boozman, John [R-AR]
Health, Education, Labor, and Pensions
07/31/2018 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Bans health insurance issuers and group health plans from prohibiting pharmacy providers from providing certain information to enrollees.X
63
S.3411Affordable Medications ActSen. Smith, Tina [D-MN]09/05/201814
Sen. Baldwin, Tammy [D-WI]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Booker, Cory A. [D-NJ]*, Sen. Brown, Sherrod [D-OH]*, Sen. Durbin, Richard J. [D-IL]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Merkley, Jeff [D-OR]*, Sen. Reed, Jack [D-RI]*, Sen. Sanders, Bernard [I-VT]*, Sen. Udall, Tom [D-NM]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Whitehouse, Sheldon [D-RI]*
Sen. Baldwin, Tammy [D-WI]*, Sen. Blumenthal, Richard [D-CT]*, Sen. Booker, Cory A. [D-NJ]*, Sen. Brown, Sherrod [D-OH]*, Sen. Durbin, Richard J. [D-IL]*, Sen. Gillibrand, Kirsten E. [D-NY]*, Sen. Hassan, Margaret Wood [D-NH]*, Sen. Klobuchar, Amy [D-MN]*, Sen. Merkley, Jeff [D-OR]*, Sen. Reed, Jack [D-RI]*, Sen. Sanders, Bernard [I-VT]*, Sen. Udall, Tom [D-NM]*, Sen. Warren, Elizabeth [D-MA]*, Sen. Whitehouse, Sheldon [D-RI]*
-Finance
09/05/2018 Referred to Committee on Finance
XXXXXXXXXX
64
S.3775Affordable Drug Manufacturing Act of 2018Sen. Warren, Elizabeth [D-MA]12/18/20180---
Health, Education, Labor, and Pensions
12/18/2018 Introduced in SenateTo establish an office to be known as the Office of Drug Manufacturing.
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