Draft Senate Legislation Expands FDA’s QIDP Designation

On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). According to the Senate HELP Committee’s press release, the bipartisan PREVENT Pandemics Act is focused on strengthening the nation’s public health and medical preparedness and response systems in the wake of the COVID-19 pandemic. In the press release, Senator Murray describes that the PREVENT Pandemics Act addresses “several of the longstanding challenges that have undermined our pandemic response from the start,” including the development process for tests, treatments and vaccines. Senator Burr similarly describes the draft legislation as “strengthen[ing] our countermeasure enterprise through advancing critical research in this field and in FDA’s development and review of these tests, treatments, and vaccines to improve readiness for future threats.” Section 501 of the draft legislation amends the Federal Food, Drug, and Cosmetic Act to expand the term “qualified infectious disease product” (QIDP) to encompass biological products that act directly on bacteria or fungi or substances produced by bacteria or fungi in addition to “antibacterial or antifungal drug[s].” Section 501 further updates priority review eligibility for products with a QIDP designation to provide priority review to biologics license applications that require clinical data to demonstrate safety or effectiveness.