HHS Roadmap Outlines FDA Flexibilities Post-Covid
A just-posted HHS “Covid-19 Public Health Emergency Transition Roadmap” says FDA and other agencies will continue to have “significant flexibilities and actions that will not be affected” as the Biden Administration transitions out of the current public health emergency in May (see earlier story).
The roadmap says the Administration is “committed to ensuring that Covid-19 vaccines and treatments will be widely accessible to all who need them. There will also be continued access to pathways for emergency use authorizations (EUAs) for Covid-19 products (tests, vaccines, and treatments) through the Food and Drug Administration (FDA), and major telehealth flexibilities will continue to exist for those participating in Medicare or Medicaid. Access to Covid-19 vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected.”
Beginning in May, Covid-19 vaccines and treatments will no longer be covered by the government because Congress has stopped the funding of these and they will become part of the traditional healthcare marketplace. “When this transition to traditional healthcare coverage occurs later this year, many Americans will continue to pay nothing out-of-pocket for the Covid-19 vaccine,” HHS says, adding that vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and typically fully covered under most private insurance plans.
Emergency use authorizations (EUAs) for Covid-19 products (including tests, vaccines, and treatments) will not be affected, the roadmap says. “The ending of the Covid-19 PHE will not affect the FDA’s ability to authorize various products, including tests, treatments, or vaccines for emergency use. Existing EUAs for Covid-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.”
HHS also notes that certain FDA Covid-19-related guidance documents that affect clinical practice and supply chains will end or be temporarily extended. “FDA published several dozen guidance documents to address challenges presented by the Covid-19 PHE, including limitations in clinical practice or potential disruptions in the supply chain. FDA is in the process of addressing which policies are no longer needed and which should be continued, with any appropriate changes, and the agency will announce plans for each guidance prior to the end of the PHE.”
Additionally, the agency’s Covid-related medical device shortage early detection ability will be more limited, HHS says. “During the PHE, manufacturers of certain devices related to the diagnosis and treatment of Covid-19 have been required to notify the FDA ‘of a permanent discontinuance in the manufacture of the device’ or ‘an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States,’” it says. This will end when the PHE ends.
The roadmap says that while FDA still has its authority to detect and address other potential medical product shortages, it is now seeking “congressional authorization to extend the requirement for device manufacturers to notify FDA of significant interruptions and discontinuances of critical devices outside of a PHE which will strengthen the ability of FDA to help prevent or mitigate device shortages.”