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What it does 

HR 6 seeks to support research, accelerate the development and access to treatments, and ultimately find cures for diseases throughout America.

  • HR 6 increases the budget for the National Institutes of Health (NIH) from the current $30.3 billion to $34.9 billion by FY2018. It allocates an additional $9.3 billion ($1.86 billion per year between 2016 and 2020) to establish the NIH and Cures Innovation Fund, which will support biomedical, basic, translational and clinical research, specifically that which focuses on biomarkers, precision medicine, infectious diseases and antibiotics.
  • The bill mandates that loan repayments and specific grants be given to  young scientists, and requires capstone grant programs and collaborative research efforts for rare and pediatric diseases.
  • HR 6 calls for patient-focused drug development and expedited patient access to diagnoses, treatments, education, and vaccines.
  • It directs the Food and Drug Administration (FDA) to support programs advancing precision medicine and the accelerated review and approval of breakthrough drugs and medical devices.
  • The bill mandates the interoperability of electronic health records to enhance telemedicine and broad access to health care across the country.
Relevant Science 

Biomarkers are proteins, enzymes, hormone levels, antibodies, etc. that are indicative of a change in physiological state, which could lead to disease. Precision medicine brings healthcare to a personal level - patients and/or biological specimens (such as tumors) are genotyped, and treatments are contoured specifically to their genetic makeup. 

Background 

21st Century Cures was introduced in a tumultuous climate for healthcare and science policy. Funding for the NIH and other national agencies has decreased significantly in the past decade. Exciting advances in genomics, neuroscience and more provide opportunities for breakthroughs in basic, translational and clinical research, but more infrastructure regarding development and delivery of health care is necessary.

Endorsements & Opposition 

HR 6 has been endorsed by numerous institutions for its commitment to research and treatment development for a broad spectrum of diseases. 

Endorsements:

Economic Impacts

  • Several research institutions, including members of the Research America Coalition and the American Association for Cancer Research, a key contributor of comments and testimonies in the bill’s revisions process, specifically commend HR 6’s attention to heightened NIH and FDA funding. AACR stated “This funding is urgently needed, as the scientific opportunity and potential for advancement in areas like precision medicine has never been greater.”
  • A May, 2015 article by 19 medical school deans cites HR 6 as a possible first step to address the instability of science funding and its grave impacts.

Electronic Health Records and Privacy

  • Academic institutions and the National Health Council commend provisions of the bill that increase research and data sharing in clinical settings. University of Virginia Professor Don Detmer states “Efficient access to records by researchers while maintaining patient privacy will unlock a vast amount of information on care delivered in different places to different patients...The evidence we can gain...from such rich data sources touches all levels and kinds of biomedical and health research.”
    • These provisions add to an ongoing debate between researchers, policy makers and ethicists weighing the importance of individual consent of clinical research subjects with the increased research bandwidth from “opt-out”, all-inclusive data sets.
  • Some health provider associations, including Premier, Inc. have expressed support for HR 6’s attention to interoperability and the standardization of health records across health care facilities.

Drug Approvals and Clinical Trials

Opposition:

Economic Impacts

  • The Wall Street Journal has highlighted a cost estimate by the Congressional Budget Office, which predicts a HR 6 provision that incentivizes new drugs for rare diseases through periods of marketing exclusivity would cost the federal government $869 million in the next five fiscal years.
  • Unlike the majority of their party, a few House Republicans voted no on the bill, citing the economic magnitude of the research allotments. One of these Representatives, Dave Brat (R-VA-7), authored an amendment to HR 6 which proposed changing the mandatory funding program of the NIH and Cures Innovation funds into a discretionary spending program. This amendment failed by a vote of 141/281.

Electronic Health Records and Privacy

Drug Approvals and Clinical Trials

  • Many opponents, including physicians, a coalition of researchers and advocates  lead by the National Physicians Alliance, and former FDA commissioner Dr. Margaret Hamburg worry that the bill’s goal to fast track drug approval is financially unreasonable and dangerous. The National Center for Health Research (NCHR) stated “[HR 6] was written primarily by pharmaceutical and device companies and reflects their desire to get medical products approved on the basis of skimpier evidence than the law currently requires... [The bill] encourages the FDA to lower its standards so that companies can sell new drugs and devices to patients based on very preliminary evidence, such as rat studies and information about just a few patients – including “case histories” of just one patient. That would take us back to the early 20th century, to an era of snake oil salesman.”
    • NCHR has also opposed provisions reducing public reporting for physicians’ “continuing education opportunities,” stating that this provides a loophole in medical transparency laws for pharmaceutical companies to continue to quietly market specific products to physicians
Status 

After a year of white papers, hearings, forums and roundtables, HR 6 was introduced May 19th, 2015, was referred to the House committee on Energy and Commerce’s Subcommittee on Health. The full committee unanimously passed the bill on May 21st. On July 10th, HR 6 was passed by the full House by a vote of 344/77 and will be sent to the Senate for consideration. House Majority Whip Steve Scalise (R-LA-1), Republican Policy Committee Chairman Luke Messer (R-IN-6) and Democratic Whip Steny Hoyer (D-MD-5) are among the co-sponsors of the bill. 

Sponsors 

HR 6 is sponsored by Rep. Fred Upton (R-MI-6). Rep. Diana DeGette (D-CO-1), Rep. Gene Green (D-TX-29), Rep. Frank Pallone, Jr. (D-NJ-6) and Rep. Joseph Pitts (R-PA-16) are original cosponsors. As of August 31st, 2015, H.R. 6 has 230 total cosponsors (121D, 109R). 

Primary Author 
Rachel Zacharias
Editor(s) 
Thomas Williams, JD, MBE
Recommended Citation 

Duke SciPol, “21st Century Cures Act (HR 6, 114th Congress)” available at http://scipol.duke.edu/content/21st-century-cures-act-hr-6-114th-congress (09/18/2015).