Biomedical Research Legislation

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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.

Childhood Cancer STAR (Survivorship, Treatment, Access, Research) Act (H.R. 820/S. 292)

  • The bill is in part a consolidation of legislative proposals introduced in past sessions of Congress focused on childhood cancer research and care (including biorepositories and biospecimen research, and survivorship research), as well as childhood cancer surveillance.  An identical bill passed the House in the 114th Congress with broad bipartisan support, but did not receive a vote in the Senate.
  • The bill authorizes NCI to support and expand collection of biospecimens from children, as well as adolescents and young adults (AYAs), diagnosed with cancer in an effort to build upon biorepositories and biospecimen research already underway with NCI support.
  • The bill also authorizes NIH, with guidance from the NCI Director and in coordination with ongoing research activities, to support grants focusing on the cause of health disparities in pediatric cancer survivorship; and focusing on late effects and follow-up care for pediatric cancer survivors.
  • Other provisions specific to NIH and NCI include requiring that at least one member appointed to the National Cancer Advisory Board be knowledgeable in pediatric oncology; establishing specific reporting requirements for NIH in addressing pediatric oncology research within its annual Pediatric Research Initiative Report to Congress; and expressing the sense of Congress that the NCI Director should ensure that all applicable study sections, committees, advisory groups, and panels at NCI should include one or more qualified pediatric oncologists; as appropriate.
  • The bill also authorizes HHS, through the Centers of Disease Control and Prevention, to award grants to state cancer registries to expand surveillance infrastructure to track the epidemiology of cancer in children and AYAs.
  • Additional provisions in the bill focus on pediatric cancer survivorship encourage the HHS Secretary to establish pilot programs to evaluate model systems for monitoring and caring for childhood cancer survivors, and carry out a 3-year demonstration project to improve quality and coordination of childhood cancer survivorship care as survivor's transition to adult care. The bill directs the HHS Secretary to establish a task force on long-term follow-up services for pediatric cancer survivors and also requires the Government Accountability Office (GAO) to submit recommendations to Congress regarding barriers to obtaining and paying for childhood cancer survivorship care.
  • H.R. 820 was introduced by Reps. Michael McCaul (R-TX), Jackie Speier (D-CA), Mike Kelly (R-PA), and G.K. Butterfield (D-NC), co-chairs of the Congressional Childhood Cancer Caucus, on 2/2/2017 and was referred to the Committee on Energy and Commerce.  The Senate companion version of this bill, S. 292, was introduced by Sens. Jack Reed (D-RI), Shelley Moore Capito (R-WV), Chris Van Hollen (D-MD), and Johnny Isakson (R-GA) on 2/2/2017 and was referred to the Committee on Health, Education, Labor, and Pensions.
  • 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.