The U.S. Senate and House of Representatives are close to agreeing on a bipartisan package of bills called the 21st Century Cures bill.
The House passed the bill on a 344 to 77 vote and the Senate Health, Education, Labor & Pension Committee has advanced five more bill as part of a series of 19 companion bills. The sticking point is $50 billion in additional mandatory funding for the National Institutes of Health (NIH) championed by Senate Democrats. Senators on both sides, according to published reports, are optimistic they will work out a deal on the amount of NIH funding and pay-fors; $9 billion over five years is a starting point. The bill is not expected to move to the Senate floor without agreement on NIH funding.
21st Century Cures Bill
The bill, when agreed to by both Houses and signed by the President will have a major impact on how the FDA regulates medical devices, drugs and combination products, includes:
- 1878, Advancing Hope Act of 2015, which would extend the priority review voucher program for rare pediatric diseases by one year and add sickle cell to the program
- 1622, The FDA Device Accountability Act of 2015, which would “streamline” FDA reviews of device trial data
- 2503, Preventing Superbugs and Protecting Patients Act, which would require FDA to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection and sterilization
- 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015
- 2014, Next Generation Researchers Act, to help attract more talented young scientists to NIH
- 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act to update rehabilitation research for the first time in more than 20 years and require the National Center for Medical Rehabilitation Research (NCMRR) to develop and periodically update a comprehensive research plan for rehabilitation research
- 849, Advancing Research for Neurological Diseases Act of 2015, to among other things, help the CDC [Centers of Disease Control] expand infrastructure and activities to track the epidemiology of neurological diseases, including multiple sclerosis and Parkinson’s disease
- 2511, Improving Health Information Technology, which deals with a host of health IT provisions, particularly around electronic health records
- 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015, which would prioritize FDA’s review of breakthrough medical devices
- 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act, which would exclude certain types of software from FDA’s purview
- 2055, The Medical Countermeasures Innovation Act of 2015, which would set up a priority review voucher program for medical countermeasures
- 1767, The Combination Products Innovation Act of 2015, which requires FDA to provide the sponsor of a product the scientific rationale supporting a determination that the product is not a medical device before making that determination, and prohibits FDA from determining that a combination product (a product that is a combination of drug, device, or biologic) is a drug solely because the product has a chemical action
- 1597, Patient Focused Impact Assessment Act of 2015, which would require the package of information published by FDA upon approval of a new drug to include documentation of efforts to assess patient engagement.
According to an April 6, 2016 RAPS (Regulatory Affairs Professionals Society) posting, while the FDA is likely to look favorably on the total bill, the agency may have heartburn with an amendment from Kansas Republican Senator Pat Roberts requiring FDA to explain why it’s using a non-binding guidance document rather than a rule in each new guidance document issued. Roberts claims the agency has used over 600 guidance documents since 2007 to establish new rules instead of just clarifying regulations. FDA Commissioner Robert Califf reported told one senator that Roberts’ amendment would throw sand into the gears of the FDA’s work.
