Updated Cure Redux and FDA’s Benefit From It
The revamped 21st Century Cures bill, unveiled, now appears slated for House and Senate passage before President-elect Donald Trump takes office.
The US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more quickly, while maintaining the same standard for safety and effectiveness that the agency has adhered to in the past.
Proponents of the bill see a necessary modernization of the regulations, as well as major funding boosts not only for FDA but for the National Institutes of Health (NIH), which would stand to gain $4.8 billion over 10 years to aid the development of Vice President Joe Biden's Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, cancer research and regenerative medicine using adult stem cells.
According to the Congressional Budget Office's review of the bill, the majority of the legislation will be paid for with funds from the Prevention and Public Health Fund. That fund has allocated more than $300 million to improve the public health immunization infrastructure, more than $100 million to raise awareness about the harms of tobacco use.
Listed below in the order in which they appear in the bill, are key sections that would have a major impact on FDA or revise the Federal Food, Drug, and Cosmetic Act (FDCA).
Sec. 1002 FDA Innovation Projects
Sec. 2034 Reducing Administrative Burden for Researchers
Sec. 2072 Global Pediatric Clinical Study Network
Sec. 3001 Patient Experience Data
Sec. 3002 Patient-Focused Drug Development Guidance
Sec 3003 Stream lining Patient Input
Sec 3004 Report on Patient Experience Drug Development
Sec 3011 Qualification of Drug Development Tool
Sec 3012 Targeted Drug For Rare Diseases
Sec. 3013 Reauthorization of [PRV] Program to Encourage Treatments for Rare Pediatric Diseases
Sec. 3014 GAO Study of Priority Review Voucher Programs
Sec. 3015 Amendments to the Orphan Drug Grants
Sec. 3016 Grants for Studying Continuous Drug Manufacturing
Sec. 3021 Novel Clinical Trial Designs
Sec. 3022 Real World Evidence
Sec. 3023 Protection of Human Research Subjects
Sec. 3024 Informed Consent Waiver or Alteration for Clinical Investigations
Sec. 3031 Summary Level Review
Sec. 3032 Expanded Access Policy
Sec. 3033 Accelerated Approval for Regenerative Advanced Therapies
Sec. 3034 Classification of Devices Used with Regenerative Advanced Therapies
Sec. 3035 Updated Regenerative Medicine Guidance and Regulations
Sec. 3036 Standards for Regenerative Medicine and Advanced Therapies
Sec. 3038 Combination Product Innovation
Sec. 3042 Limited Population Pathway
Sec. 3044 Susceptibility Test Interpretive Criteria for Microorganisms
Sec. 3051 Breakthrough Devices