On April 6th, the Senate Health, Education, Labor and Pensions (HELP) Committee held the last of three markups to discuss biomedical innovation legislation. The legislation considered and approved in those mark-ups will be conferenced with the 21st Century Cures Act which passed the House of Representatives with broad bipartisan support last summer. In addition to approving the five bills under consideration, members of the Committee offered several amendments of particular interest to the rare disease community.
Senator Hatch (R-UT) highlighted the need for new therapies for patients with rare diseases when he offered and withdrew S. 1421, the OPEN ACT (Orphan Products Extensions, Now Accelerating Cures and Treatment Act). This followed a day of action in which hundreds of advocates called Washington, D.C. in support of the Committee moving the bill. The OPEN ACT would encourage biopharmaceutical companies to repurpose approved therapies for rare disease by providing six additional months of market exclusivity. Although he withdrew the legislation, Sen. Hatch believes that it should be part of the final package and he asked the Committee to work with him to find an offset to pay for the measure. Please contact your legislators to ask them to co-sponsor the OPEN ACT.
Sen. Burr (R-NC) gave a compelling statement in support of including the OPEN ACT in the final package.
Senator Kirk (R-IL) also offered and withdrew an amendment to cut the time it takes to bring regenerative therapies to market. Senators Isakson (R-GA), Alexander (R-TN), and Murray (D-WA) spoke in support.
The five bills passed today included:
- S. 2700 – FDA and NIH Workforce Authorities Modernization Act (Alexander, R-TN), which directs the Food and Drug Administration (FDA) to increase intercenter coordination and reforms the salary structure at FDA and the National Institutes of Health (NIH).
- S. 185 – Promise for Antibiotics and Therapeutics for Health Act (Hatch, R-UT), which allows the FDA to create a pathway for approval and labeling of antibacterial drugs for limited populations.
- S. 2713 – Advancing Precision Medicine Act of 2016 (Alexander, R-TN), which provides for the implementation of a Precision Medicine Initiative.
- S. 2745 – Advancing NIH Strategic Planning and Representation in Medical Research Act (Collins, R-ME), which would promote the inclusion of minorities in clinical research and drug development.
- S. 2742 – Promoting Biomedical Research and Public Health for Patients Act (Alexander, R-TN), which is a wide-ranging bill with numerous provisions for NIH, FDA and other Health and Human Services (HHS) agencies.
The Committee continues to negotiate an NIH Innovation Fund as part of the package, which would create funding for the White House’s Precision Medicine and National Cancer Moonshot initiatives, the Young Investigator Corps, Big Biothink Awards and the BRAIN Initiative. Once a deal is struck, the bill will move to the Senate floor for a final vote before the bill can be conferenced with the 21stCentury Cures Act.