The latest stories from healthcare and the life sciences in the US. Vinay Prasad is reinstated as head of the FDA’s CBER following a brief resignation; HHS fires Gray Delany amid fallout from abrupt mRNA contract cuts; the federal Task Force on Safer Childhood Vaccines is revived after three decades with NIH’s Jay Bhattacharya at the helm; and President Trump signs a new executive order to boost domestic stockpiles of essential pharmaceutical ingredients.
He’s Back: Vinay Prasad Returns As FDA CBER Head (PharmaExec)
Vinay Prasad, MD, MPH, who was appointed to run the FDA’s Center for Biologics Evaluation and Research (CBER) in May, then resigned in late July after he was criticized by right-wing commentator Laura Loomer is now back running CBER. Prasad is back at the request of FDA Commissioner Marty Makary, according to media reports, after the White House reviewed the past remarks that Loomer criticized. An HHS spokesman told Politico: “Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.”
Gray Delany, head of Make America Healthy Again (MAHA) implementation at the Department of Health and Human Services (HHS) and an ally of Secretary Robert F. Kennedy Jr., has been fired from his government role, according to a source familiar with the decision. Delany was fired soon after Secretary Kennedy’s announcement Tuesday that the Biomedical Advanced Research and Development Authority, or BARDA, was cutting 22 contracts with mRNA vaccine makers. The person described Delany’s firing as driven by disagreement between Delany and other top HHS officials over how major policy announcements are rolled out.
Kennedy Revives Childhood Vaccines Safety Group, Led by NIH’s Bhattacharya (BioSpace)
After nearly 30 years of dormancy, HHS is reinstating the Task Force on Safer Childhood Vaccines to develop and refine immunization guidelines for children across the country. Jay Bhattacharya, director of the National Institutes of Health, has been tapped to head the task force. The panel will put out regular recommendations regarding vaccine development, promotion and surveillance. The new task force will work with the Advisory Commission on Childhood Vaccines (ACCV), a panel that reviews issues related to the Vaccine Injury Compensation Program. The task force will submit a formal report to Congress within two years, with updates every two years after that, according to the announcement. The group’s recommendations will help produce vaccines “that result in fewer and less serious adverse reactions than those vaccines currently on the market.”
Roughly three months after signing an executive order to streamline the construction of drug manufacturing plants in the US, President Donald Trump has issued another directive aimed at shoring up the country’s pharmaceutical supply chain. Trump inked a new order calling on the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) to identify and stockpile active pharmaceutical ingredients for roughly 26 medicines the agency deems essential. The ASPR will have 30 days to develop the roster of drugs that are “especially critical to the health and security interests of the nation,” according to an Aug. 13 White House release.
