The Senate Committee on Health, Education, Labor and Pensions (HELP) convened a markup of the PREVENT Pandemics Act (S.3799) last week and favorably reported the bill as amended to the Senate. The pandemic preparedness bill focuses on strengthening and modernizing Federal public health and medical preparedness and response systems and includes the following provisions:
- Improve strategy and coordination among public health preparedness agencies
- Strengthen supply chain and government stockpiles of medical products, including masks, vaccines, and tests
- Ensure accountability of the Centers for Disease Control and Prevention (CDC) by requiring a Senate-confirmed CDC Director and agencywide strategic plan
- Revitalize the public and community health workforce
- Address disparities among at-risk populations and communities
During the committee markup, Senator Rand Paul (R-KY) proposed amending the pandemic preparedness bill to include the Verified Innovative Testing in American Laboratories (VITAL) Act (S.1666 ), which would allow regulation of all laboratory developed tests (LDTs) to remain within the current regulatory system under the Centers for Medicare & Medicaid Services. In response to the proposed amendment, Senate HELP Chair Patty Murray (D-WA) reported that she and Ranking Member Richard Burr (R-NC) are working on legislation—the Verifying Accurate Leading-edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act (S.2209)—to establish a new regulatory framework to review and approve LDTs under the authority of the Food and Drug Administration. Chairperson Murray requested committee members’ input on the bill and said that the Medical Device User Fee Amendments reauthorization package would be an appropriate legislative vehicle for the VALID Act.
GNYHA will focus our advocacy on the regulation of LDTs and the VALID Act as legislative activity on the Hill intensifies.