Legal & Regulatory

Updated Cure Redux and FDA’s Benefit From It

November 30
5:21 AM 2016

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

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