Senate HELP Committee Marks Up Precision Medicine, Other “Cures” Bills
Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a final mark-up of legislation comprising the Committee’s counterpart to the House-passed 21st Century Cures Act. The HELP Committee approved five bills including S. 2713 to advance the development of “precision medicine” through research and data sharing.
The Advancing Precision Medicine Act of 2016 would encourage the Secretary of Health and Human Services (HHS) to establish a Precision Medicine Initiative (PMI) in collaboration with the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology.
The PMI could involve the development of a network of researchers to collaborate on new precision medicine approaches, as well as the collection of information from a voluntary cohort of individuals. The Secretary would be required to ensure appropriate data sharing across systems and to provide privacy and data security protections. The manager’s amendment adopted by the HELP Committee yesterday added additional privacy provisions to allow HHS to exempt from disclosure certain identifiable biomedical information of cohort participants; to permit the NIH to impose data sharing requirements on recipients of NIH grants or cooperative agreements; and to allow the NIH to conduct certain “high-risk, high-reward research.” The manager’s amendment did not include provisions recently sought by stakeholders, such as the adoption of open-data standards or a requirement for a single, HIPAA-consistent consent form for use across the patient cohort.
The HELP Committee approved four other bills during yesterday’s session, including: S. 2700, the FDA and NIH Workforce Authorities Modernization Act; S. 185, the Promise for Antibiotics and Therapeutics for Health (PATH) Act, to establish a limited population approval process for antibiotics and to encourage reporting on antibiotic use and resistance; S. 2745, the Advancing NIH Strategic Planning and Representation in Medical Research Act; and S. 2742, the Promoting Biomedical Research and Public Health for Patients Act.
The measures reported yesterday are expected to be combined with bills the Committee reported in February and an as-yet-to-be-determined proposal for NIH “innovation” funding before being sent to the full Senate.