Biomedical Research Legislation

The below list features proposed legislation from the 115th Congress affecting biomedical research policy, such as reauthorization of the Small Business Innovation Research (SBIR) program and other measures affecting how biomedical research is performed.

Advancing Cutting Edge (ACE) Research Act (S. 2406/H.R. 5002)

  • The bill would expand the NIH’s “other transaction authority” (OTA), giving the NIH Director more flexibility to approve high-impact research projects to address public health threats.
  • Introduced in the Senate on February 8, 2018 by Sens. Alexander (R-TN) and Murray (D-WA) and the House on February 13, 2018 by Reps. Dingell (D-MI) and Upton (R-MI). The Senate version has four cosponsors and the House version has two.
  • Read the full bill text on Congress.gov.

National Biomedical Research Act (S. 2212)

  • The bill would establish a Biomedical Research Innovation Fund, directing the Secretary of the Treasury to transfer $5 billion per year from the Treasury’s general fund to the Biomedical Research Innovation Fund for ten years. Funds would be disbursed to NIH and FDA, proportional to each agencies’ discretionary appropriations.
  • The bill directs NIH and FDA to use the funds to support specific research efforts, including basic research and support of early-career scientists.
  • This new funding would supplement, not supplant discretionary appropriations for NIH and FDA.
  • The bill was introduced on 12/7/2017 by Sen. Elizabeth Warren (D-MA) along with 15 original cosponsors and referred to the HELP Committee.
  • Read the full bill text on Congress.gov.

Enhanced Clinical Trial Design Act of 2017 (S. 1048)

  • The bill aimes to expand patient access to experimental treatments in clinical trials by enhancing the clinical trials process and providing updated guidance on eligibility criteria.
  • The bill would require the FDA and the NIH to convene a public meeting to discuss clinical trial criteria, including: barriers to participation, alternative clinical trial designs, and potential impact of changes to clinical trial inclusion and exclusion criteria.
  • The Secretary would be required to issue a public report on the topics discussed at the meeting as well as guidance documents regarding eligibility criteria for clinical trials.
  • In addition, the FDA would be required to issue guidance to streamline the institutional review board (IRB) review process for individual pediatric and adult patient expanded access protocol and how the IRBs may facilitate the use of the protocols.
  • S. 1048 was introduced by Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on 5/5/2017.
  • Read the full bill text on Congress.gov.

Creating Requirements for Federal Agencies with a SBIR/STTR Program (H.R. 2780)

  • The bill would amend the Small Business Act to require Federal Agencies with a SBIR or STTR Program to hold an annual meeting to discuss methods to:
    • Improve the collection and reporting of data;
    • Make the application processes more efficient; and
    • Increase participation.
  • The bill would require a report to be submitted to Congress on the findings and recommendations resulting from the meeting.
  • The bill would also require that a portion of funds be used to increase participation in States that have historically received a low level of SBIR awards.
  • H.R. 2780 was introduced by Rep. Dwight Evans (D-PA) on 6/6/2017 and was referred to the Science, Space, and Technology Committee.
  • Read the full bill text on Congress.gov.

The Research to Accelerate Cures and Equity (RACE) for Children Act (S. 456/H.R. 1231)

  • The billwould amend the Federal Food, Drug, and Cosmetics Act, modifying the Pediatric Research Equity Act (PREA) to require further evaluation of cancer drugs or biologics that have potential therapeutic benefits for pediatric cancer patients based on molecular targets, rather than the cancer site that the drug or biologic is indicated for adult use.
  • In addition, this bill would remove the orphan waiver under PREA for drugs directed at a specific molecular target that is relevant to the growth and progression of a pediatric cancer.
  • The bill would also require the submission of a report to Congress on the implementation of the amendments resulting from this bill, if enacted.
  • S. 456 was introduced on 2/27/2017 by Sens. Michael Bennet (D-CO), Marco Rubio (R-FL), Cory Gardner (R-CO), and Chris Van Hollen (D-MD) and was referred to the HELP Committee. H.R. 1231 was introduced by Reps. Michael McCaul (R-TX), G.K. Butterfield (D-NC), Sean Duffy (R-WI), and Yvette Clarke (D-NY) on 2/27/2017 and was referred to the Energy and Commerce Committee.
  • Read the full bill text on Congress.gov.