21st Century Cures Act
Sponsored By: Representative FRED UPTON
Unknown
Summary
21st Century Cures Act This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research. The NIH may require scientific data to be shared if the research is fully funded by the NIH. The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data. The Centers for Disease Control and Prevention must expand surveillance of neurological diseases. The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures. The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs. Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication. Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests. The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition. The priority review voucher program for rare pediatric diseases is revised and extended. The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices. Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption. “Health software” is defined and, with certain exceptions, exempted from FDA regulations. This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services. A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products. Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs. This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
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Bill Overview
No Economic Impacts Identified for this Bill
Sponsors & CoSponsors
Sponsor
FRED UPTON
MI • R
Cosponsors
Sen. Cramer, Kevin [R-ND]
ND • R
Sponsored 5/22/2015
Rep. Bucshon, Larry [R-IN-8]
IN • R
Sponsored 5/22/2015
Bilirakis
FL • R
Sponsored 5/22/2015
Sen. Blackburn, Marsha [R-TN]
TN • R
Sponsored 5/22/2015
Rep. Brooks, Susan W. [R-IN-5]
IN • R
Sponsored 5/22/2015
Rep. Burgess, Michael C. [R-TX-26]
TX • R
Sponsored 5/22/2015
Rep. Ellmers, Renee L. [R-NC-2]
NC • R
Sponsored 5/22/2015
Rep. Griffith, H. Morgan [R-VA-9]
VA • R
Sponsored 5/22/2015
Rep. Guthrie, Brett [R-KY-2]
KY • R
Sponsored 5/22/2015
Rep. Lance, Leonard [R-NJ-7]
NJ • R
Sponsored 5/22/2015
Rep. McKinley, David B. [R-WV-1]
WV • R
Sponsored 5/22/2015
Rep. McMorris Rodgers, Cathy [R-WA-5]
WA • R
Sponsored 5/22/2015
Markwayne Mullin
OK • R
Sponsored 5/22/2015
Rep. Murphy, Tim [R-PA-18]
PA • R
Sponsored 5/22/2015
JOHN SHIMKUS
IL • R
Sponsored 5/22/2015
GREG WALDEN
OR • R
Sponsored 5/22/2015
EDWARD WHITFIELD
KY • R
Sponsored 5/22/2015
Rep. Roskam, Peter J. [R-IL-6]
IL • R
Sponsored 5/22/2015
Rep. Hanna, Richard L. [R-NY-22]
NY • R
Sponsored 5/22/2015
Rep. McCaul, Michael T. [R-TX-10]
TX • R
Sponsored 5/22/2015
Rep. Comstock, Barbara [R-VA-10]
VA • R
Sponsored 5/22/2015
Rep. Harris, Andy [R-MD-1]
MD • R
Sponsored 5/22/2015
Rep. Marchant, Kenny [R-TX-24]
TX • R
Sponsored 5/22/2015
Rep. Yarmuth, John A. [D-KY-3]
KY • D
Sponsored 5/22/2015
Rep. Castor, Kathy [D-FL-14]
FL • D
Sponsored 5/22/2015
Rep. Loebsack, David [D-IA-2]
IA • D
Sponsored 5/22/2015
Rep. Schakowsky, Janice D. [D-IL-9]
IL • D
Sponsored 5/22/2015
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 5/22/2015
Rep. Moore, Gwen [D-WI-4]
WI • D
Sponsored 5/22/2015
Rep. Veasey, Marc A. [D-TX-33]
TX • D
Sponsored 5/22/2015
Rep. Dingell, Debbie [D-MI-6]
MI • D
Sponsored 5/22/2015
CHAKA FATTAH
PA • D
Sponsored 5/22/2015
Rep. Schrader, Kurt [D-OR-5]
OR • D
Sponsored 5/22/2015
RICHARD NOLAN
MN • D
Sponsored 5/22/2015
Rep. Eshoo, Anna G. [D-CA-16]
CA • D
Sponsored 5/22/2015
Peter Welch
VT • D
Sponsored 5/22/2015
Rep. Scott, David [D-GA-13]
GA • D
Sponsored 5/22/2015
Rep. Perlmutter, Ed [D-CO-7]
CO • D
Sponsored 5/22/2015
Rep. Courtney, Joe [D-CT-2]
CT • D
Sponsored 5/22/2015
Rep. Cohen, Steve [D-TN-9]
TN • D
Sponsored 5/22/2015
Rep. DeSaulnier, Mark [D-CA-10]
CA • D
Sponsored 5/22/2015
Rep. Long, Billy [R-MO-7]
MO • R
Sponsored 5/22/2015
Rep. Butterfield, G. K. [D-NC-1]
NC • D
Sponsored 5/22/2015
Rep. Clarke, Yvette D. [D-NY-9]
NY • D
Sponsored 5/22/2015
MIKE DOYLE
PA • D
Sponsored 5/22/2015
Rep. DeGette, Diana [D-CO-1]
CO • D
Sponsored 5/19/2015
JOSEPH PITTS
PA • R
Sponsored 5/19/2015
Rep. Pallone, Frank [D-NJ-6]
NJ • D
Sponsored 5/19/2015
GENE GREEN
TX • D
Sponsored 5/19/2015
JOE BARTON
TX • R
Sponsored 5/22/2015
Rep. Joyce, David P. [R-OH-14]
OH • R
Sponsored 6/17/2015
Rep. Valadao, David G. [R-CA-22]
CA • R
Sponsored 6/17/2015
Rep. Ashford, Brad [D-NE-2]
NE • D
Sponsored 6/17/2015
Rep. Nadler, Jerrold [D-NY-12]
NY • D
Sponsored 6/18/2015
Rep. Wasserman Schultz, Debbie [D-FL-25]
FL • D
Sponsored 6/18/2015
Rep. Trott, David A. [R-MI-11]
MI • R
Sponsored 6/18/2015
Rep. Kaptur, Marcy [D-OH-9]
OH • D
Sponsored 6/18/2015
Rep. Kelly, Robin L. [D-IL-2]
IL • D
Sponsored 6/18/2015
CHARLES RANGEL
NY • D
Sponsored 6/18/2015
Rep. Fudge, Marcia L. [D-OH-11]
OH • D
Sponsored 6/18/2015
Rep. McGovern, James P. [D-MA-2]
MA • D
Sponsored 6/18/2015
Rep. Reed, Tom [R-NY-23]
NY • R
Sponsored 6/18/2015
Rep. Huizenga, Bill [R-MI-4]
MI • R
Sponsored 6/18/2015
BOBBY RUSH
IL • D
Sponsored 5/22/2015
ELIOT ENGEL
NY • D
Sponsored 5/22/2015
Rep. McNerney, Jerry [D-CA-9]
CA • D
Sponsored 5/22/2015
Rep. Matsui, Doris O. [D-CA-7]
CA • D
Sponsored 5/22/2015
Rep. Flores, Bill [R-TX-17]
TX • R
Sponsored 6/1/2015
Rep. Johnson, Bill [R-OH-6]
OH • R
Sponsored 6/1/2015
Rep. Gibson, Christopher P. [R-NY-19]
NY • R
Sponsored 6/1/2015
Rep. Kennedy, Joseph P., III [D-MA-4]
MA • D
Sponsored 6/1/2015
Sen. Luján, Ben Ray [D-NM]
NM • D
Sponsored 6/1/2015
Rep. Walz, Timothy J. [D-MN-1]
MN • D
Sponsored 6/1/2015
Rep. Castro, Joaquin [D-TX-20]
TX • D
Sponsored 6/1/2015
Rep. Bustos, Cheri [D-IL-17]
IL • D
Sponsored 6/1/2015
Rep. Frankel, Lois [D-FL-22]
FL • D
Sponsored 6/1/2015
Rep. Brownley, Julia [D-CA-26]
CA • D
Sponsored 6/1/2015
Rep. Costa, Jim [D-CA-21]
CA • D
Sponsored 6/1/2015
Rep. Wagner, Ann [R-MO-2]
MO • R
Sponsored 6/1/2015
Rep. Davis, Rodney [R-IL-13]
IL • R
Sponsored 6/1/2015
Scalise
LA • R
Sponsored 6/2/2015
Latta
OH • R
Sponsored 6/2/2015
Rep. Harper, Gregg [R-MS-3]
MS • R
Sponsored 6/2/2015
Rep. Olson, Pete [R-TX-22]
TX • R
Sponsored 6/2/2015
Rep. Kinzinger, Adam [R-IL-16]
IL • R
Sponsored 6/2/2015
Rep. Pompeo, Mike [R-KS-4]
KS • R
Sponsored 6/2/2015
Rep. Collins, Chris [R-NY-27]
NY • R
Sponsored 6/2/2015
Rep. Walters, Mimi [R-CA-45]
CA • R
Sponsored 6/2/2015
Allen
GA • R
Sponsored 6/2/2015
Rep. Sarbanes, John P. [D-MD-3]
MD • D
Sponsored 6/2/2015
Rep. Lee, Barbara [D-CA-12]
CA • D
Sponsored 6/2/2015
Rep. Miller, Candice S. [R-MI-10]
MI • R
Sponsored 6/3/2015
Rep. Higgins, Brian [D-NY-26]
NY • D
Sponsored 6/3/2015
Rep. Huffman, Jared [D-CA-2]
CA • D
Sponsored 6/3/2015
Rep. Kildee, Daniel T. [D-MI-8]
MI • D
Sponsored 6/3/2015
Rep. Quigley, Mike [D-IL-5]
IL • D
Sponsored 6/3/2015
Rep. Takai, Mark [D-HI-1]
HI • D
Sponsored 6/3/2015
Rep. Heck, Joseph J. [R-NV-3]
NV • R
Sponsored 6/3/2015
Resident Commissioner Pierluisi, Pedro R. [D-PR-At Large]
PR • D
Sponsored 6/3/2015
Rep. Benishek, Dan [R-MI-1]
MI • R
Sponsored 6/4/2015
Rep. Walorski, Jackie [R-IN-2]
IN • R
Sponsored 6/9/2015
STEVE ISRAEL
NY • D
Sponsored 6/9/2015
Rep. Hultgren, Randy [R-IL-14]
IL • R
Sponsored 6/9/2015
Rep. Kuster, Ann M. [D-NH-2]
NH • D
Sponsored 6/9/2015
Rep. Yoder, Kevin [R-KS-3]
KS • R
Sponsored 6/9/2015
Rep. Dent, Charles W. [R-PA-15]
PA • R
Sponsored 6/9/2015
Rep. Curbelo, Carlos [R-FL-26]
FL • R
Sponsored 6/9/2015
Rep. Kirkpatrick, Ann [D-AZ-1]
AZ • D
Sponsored 6/9/2015
Rep. Polis, Jared [D-CO-2]
CO • D
Sponsored 6/9/2015
Rep. O'Rourke, Beto [D-TX-16]
TX • D
Sponsored 6/9/2015
Hudson
NC • R
Sponsored 6/9/2015
Rep. Cárdenas, Tony [D-CA-29]
CA • D
Sponsored 6/9/2015
LOIS CAPPS
CA • D
Sponsored 6/9/2015
Rep. Roe, David P. [R-TN-1]
TN • R
Sponsored 6/9/2015
Rep. Bishop, Mike [R-MI-8]
MI • R
Sponsored 6/9/2015
Rep. Ross, Dennis A. [R-FL-15]
FL • R
Sponsored 6/9/2015
Rep. Payne, Donald M., Jr. [D-NJ-10]
NJ • D
Sponsored 6/9/2015
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 6/11/2015
Rep. Dold, Robert J. [R-IL-10]
IL • R
Sponsored 6/11/2015
Rep. Turner, Michael R. [R-OH-10]
OH • R
Sponsored 6/11/2015
Rep. Coffman, Mike [R-CO-6]
CO • R
Sponsored 6/11/2015
Rep. Sires, Albio [D-NJ-8]
NJ • D
Sponsored 6/11/2015
Rep. Meadows, Mark [R-NC-11]
NC • R
Sponsored 6/11/2015
Rep. Costello, Ryan A. [R-PA-6]
PA • R
Sponsored 6/11/2015
LUIS GUTIERREZ
IL • D
Sponsored 6/11/2015
Rep. Messer, Luke [R-IN-6]
IN • R
Sponsored 6/11/2015
Rep. Walberg, Tim [R-MI-5]
MI • R
Sponsored 6/11/2015
MATT SALMON
AZ • R
Sponsored 6/11/2015
Rep. Jenkins, Evan H. [R-WV-3]
WV • R
Sponsored 6/11/2015
Rep. Pocan, Mark [D-WI-2]
WI • D
Sponsored 6/11/2015
Rep. Peters, Scott H. [D-CA-50]
CA • D
Sponsored 6/11/2015
Rep. Torres, Norma J. [D-CA-35]
CA • D
Sponsored 6/15/2015
Rep. Lofgren, Zoe [D-CA-18]
CA • D
Sponsored 6/15/2015
Rep. Meng, Grace [D-NY-6]
NY • D
Sponsored 6/15/2015
Rep. Takano, Mark [D-CA-39]
CA • D
Sponsored 6/15/2015
Rep. Pittenger, Robert [R-NC-9]
NC • R
Sponsored 6/15/2015
Rep. Denham, Jeff [R-CA-10]
CA • R
Sponsored 6/15/2015
Rep. Barletta, Lou [R-PA-11]
PA • R
Sponsored 6/15/2015
Rep. Hardy, Cresent [R-NV-4]
NV • R
Sponsored 6/15/2015
Rep. Ruppersberger, C. A. Dutch [D-MD-2]
MD • D
Sponsored 6/15/2015
Rep. Vargas, Juan [D-CA-52]
CA • D
Sponsored 6/15/2015
Rep. Garamendi, John [D-CA-8]
CA • D
Sponsored 6/15/2015
Rep. Heck, Denny [D-WA-10]
WA • D
Sponsored 6/15/2015
Rep. Bera, Ami [D-CA-6]
CA • D
Sponsored 6/15/2015
Rep. Luetkemeyer, Blaine [R-MO-3]
MO • R
Sponsored 6/16/2015
Rep. Zeldin, Lee M. [R-NY-1]
NY • R
Sponsored 6/16/2015
Rep. Clark, Katherine M. [D-MA-5]
MA • D
Sponsored 6/16/2015
Rep. Bost, Mike [R-IL-12]
IL • R
Sponsored 6/16/2015
Rep. Lawrence, Brenda L. [D-MI-14]
MI • D
Sponsored 6/16/2015
Rep. Velázquez, Nydia M. [D-NY-7]
NY • D
Sponsored 6/16/2015
Rep. Rogers, Mike D. [R-AL-3]
AL • R
Sponsored 6/16/2015
Rep. Edwards, Donna F. [D-MD-4]
MD • D
Sponsored 6/17/2015
Rep. Young, David [R-IA-3]
IA • R
Sponsored 6/17/2015
Rep. Katko, John [R-NY-24]
NY • R
Sponsored 6/17/2015
Rep. Moulton, Seth [D-MA-6]
MA • D
Sponsored 6/17/2015
Rep. Fortenberry, Jeff [R-NE-1]
NE • R
Sponsored 6/17/2015
Rep. McHenry, Patrick T. [R-NC-10]
NC • R
Sponsored 6/17/2015
RUBEN HINOJOSA
TX • D
Sponsored 6/17/2015
Rep. Cartwright, Matt [D-PA-8]
PA • D
Sponsored 6/17/2015
Rep. Moolenaar, John R. [R-MI-2]
MI • R
Sponsored 6/18/2015
Rep. Donovan, Daniel M., Jr. [R-NY-11]
NY • R
Sponsored 6/18/2015
Rep. Wenstrup, Brad R. [R-OH-2]
OH • R
Sponsored 6/18/2015
Rep. Ellison, Keith [D-MN-5]
MN • D
Sponsored 6/18/2015
ALCEE HASTINGS
FL • D
Sponsored 6/18/2015
CAROLYN MALONEY
NY • D
Sponsored 6/18/2015
LaMalfa
CA • R
Sponsored 6/18/2015
ANDER CRENSHAW
FL • R
Sponsored 6/18/2015
Rep. Sinema, Kyrsten [D-AZ-9]
AZ • D
Sponsored 6/18/2015
Rep. McCollum, Betty [D-MN-4]
MN • D
Sponsored 6/18/2015
Webster (FL)
FL • R
Sponsored 6/18/2015
Del. Bordallo, Madeleine Z. [D-GU-At Large]
GU • D
Sponsored 6/18/2015
Rep. Gibbs, Bob [R-OH-7]
OH • R
Sponsored 6/23/2015
Rep. Boyle, Brendan F. [D-PA-2]
PA • D
Sponsored 6/23/2015
Rep. Conaway, K. Michael [R-TX-11]
TX • R
Sponsored 6/23/2015
Rep. Knight, Stephen [R-CA-25]
CA • R
Sponsored 6/23/2015
Womack
AR • R
Sponsored 6/23/2015
DesJarlais
TN • R
Sponsored 6/23/2015
ED ROYCE
CA • R
Sponsored 6/23/2015
Rep. Diaz-Balart, Mario [R-FL-26]
FL • R
Sponsored 6/23/2015
Rep. Stefanik, Elise M. [R-NY-21]
NY • R
Sponsored 6/23/2015
Rep. Zinke, Ryan K. [R-MT-1]
MT • R
Sponsored 6/23/2015
MICHAEL CAPUANO
MA • D
Sponsored 6/23/2015
Rep. Jackson Lee, Sheila [D-TX-18]
TX • D
Sponsored 6/23/2015
PATRICK TIBERI
OH • R
Sponsored 6/23/2015
Rep. Herrera Beutler, Jaime [R-WA-3]
WA • R
Sponsored 6/23/2015
Sen. Van Hollen, Chris [D-MD]
MD • D
Sponsored 6/23/2015
Rep. Guinta, Frank C. [R-NH-1]
NH • R
Sponsored 6/23/2015
ILEANA ROS-LEHTINEN
FL • R
Sponsored 6/23/2015
Simpson
ID • R
Sponsored 6/23/2015
Rep. Bonamici, Suzanne [D-OR-1]
OR • D
Sponsored 6/24/2015
Rep. Cicilline, David N. [D-RI-1]
RI • D
Sponsored 6/24/2015
Rep. Lipinski, Daniel [D-IL-3]
IL • D
Sponsored 6/24/2015
Rep. Rice, Kathleen M. [D-NY-4]
NY • D
Sponsored 6/24/2015
Rep. Paulsen, Erik [R-MN-3]
MN • R
Sponsored 6/24/2015
Rep. Speier, Jackie [D-CA-14]
CA • D
Sponsored 6/24/2015
Rep. Cook, Paul [R-CA-8]
CA • R
Sponsored 6/24/2015
JAMES LANGEVIN
RI • D
Sponsored 6/24/2015
Rep. Stivers, Steve [R-OH-15]
OH • R
Sponsored 6/24/2015
Rep. Cleaver, Emanuel [D-MO-5]
MO • D
Sponsored 6/24/2015
Rep. Collins, Doug [R-GA-9]
GA • R
Sponsored 6/24/2015
Rep. Hunter, Duncan D. [R-CA-50]
CA • R
Sponsored 6/24/2015
Rep. Hahn, Janice [D-CA-44]
CA • D
Sponsored 6/24/2015
Rep. Rigell, E. Scott [R-VA-2]
VA • R
Sponsored 6/24/2015
STEVE CHABOT
OH • R
Sponsored 6/24/2015
Rep. DelBene, Suzan K. [D-WA-1]
WA • D
Sponsored 6/24/2015
FRANK LOBIONDO
NJ • R
Sponsored 6/24/2015
LUCILLE ROYBAL-ALLARD
CA • D
Sponsored 6/25/2015
Rep. Perry, Scott [R-PA-10]
PA • R
Sponsored 6/25/2015
Rep. Delaney, John K. [D-MD-6]
MD • D
Sponsored 6/25/2015
JOHN LEWIS
GA • D
Sponsored 6/25/2015
Rep. Lieu, Ted [D-CA-36]
CA • D
Sponsored 6/25/2015
Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4]
GA • D
Sponsored 6/25/2015
Rep. Wilson, Frederica S. [D-FL-24]
FL • D
Sponsored 6/25/2015
Rep. Keating, William R. [D-MA-9]
MA • D
Sponsored 6/25/2015
CORRINE BROWN
FL • D
Sponsored 6/25/2015
RON KIND
WI • D
Sponsored 6/25/2015
Rep. Marino, Tom [R-PA-10]
PA • R
Sponsored 6/25/2015
ROBERT BRADY
PA • D
Sponsored 6/25/2015
SAM FARR
CA • D
Sponsored 6/25/2015
Rep. Calvert, Ken [R-CA-41]
CA • R
Sponsored 6/25/2015
Rep. Larson, John B. [D-CT-1]
CT • D
Sponsored 6/25/2015
Rep. Chu, Judy [D-CA-28]
CA • D
Sponsored 6/25/2015
Hoyer
MD • D
Sponsored 6/25/2015
EDDIE JOHNSON
TX • D
Sponsored 6/25/2015
Rep. Waters, Maxine [D-CA-43]
CA • D
Sponsored 6/25/2015
Rep. Lowenthal, Alan S. [D-CA-47]
CA • D
Sponsored 6/25/2015
TIM RYAN
OH • D
Sponsored 6/25/2015
SUSAN DAVIS
CA • D
Sponsored 6/25/2015
Rep. Kilmer, Derek [D-WA-6]
WA • D
Sponsored 6/25/2015
Sen. Duckworth, Tammy [D-IL]
IL • D
Sponsored 6/25/2015
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov