FDA Is Reshuffling Leadership Roles As Angst Deepens With Pazdur Exit
Theresa Michele, the director of the Office of Nonprescription Drugs, has been reassigned. Tracy Beth Høeg will take the reins at the Center for Drug Evaluation and Research. Also, Richard Pazdur's abrupt retirement from CDER has reignited fears that the agency is imploding, Axios reports.
Stat:
FDA Removes Office Of Nonprescription Drugs Director Theresa Michele
The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT. (Lawrence, 12/3)
Stat:
Tracy Beth Høeg Will Lead FDA Center For Drug Evaluation And Research
Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research, according to an announcement from the FDA. (Lawrence and Cirruzzo, 12/3)
Axios:
Kennedy Meets With FDA Official Amid Agency Worker Turmoil
Health Secretary Robert F. Kennedy Jr. today met with the FDA's departing top drug regulator amid concerns the agency is in turmoil, two sources familiar with the situation told Axios. The appointment of veteran cancer specialist Rick Pazdur to lead the agency's drug center mere weeks ago came as an enormous relief to the biopharmaceutical industry, and his pending retirement has reignited fears that the agency is imploding. (Owens, 12/3)
More from the FDA —
The Wall Street Journal:
Turmoil At The FDA Threatens Biotech Recovery
The Trump administration’s ambition to unleash biomedical innovation and sharpen America’s edge against China is colliding with a far messier reality inside the Food and Drug Administration. Investors riding a rare biotech recovery don’t need to jump off the train, but they should expect a bumpier ride. (Wainer, 12/4)
Stat:
FDA Plans To Require Just A Single Clinical Trial For New Approvals
The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. (Lawrence, 12/4)
Related news about the effects of federal funding cutbacks —
MedPage Today:
New NIH Policies Make It Easier To End Grants, Ignore Peer Review
November brought yet another round of changes at the NIH -- including a new policy that makes it easier to terminate grants, a shift away from its standard process for awarding grants, and the replacement of AIDS research leadership. All new grants must have language stating that they can be terminated "if the agency determines that the award no longer effectuates the program goals or agency priorities," according to a notice posted Nov. 18. (Fiore, 12/3)
Stat:
Trump Science Funding Cuts Shake The Foundation Of U.S. Research
For a substantial group of U.S. researchers, 2025 will be remembered as the year their path to a career in science was closed off, their dreams dashed. For others, it will go down as a chaotic game of red-light-green-light that left them constantly unsure of what work would be funded or halted, but that they managed to survive. For nearly everyone, the last 10 months have revealed that the research enterprise that catapulted the country to the technological fore was much more brittle than expected. (Molteni, Oza and Parker, 12/4)
Stat:
What West Virginia Teens Lost When CDC Cuts Ended Their Fight Against Big Tobacco
Breanna Cutright was getting her nails painted purple for junior prom when the email arrived on her phone with bad news. Raze, an anti-tobacco program focused on young people across West Virginia, was shutting down because of federal funding cuts. (Todd, 12/4)
Politico:
Bill Gates: Shrinking Global Health Funding Will Cause Rise In Childhood Mortality Rates
Gates Foundation co-founder Bill Gates said childhood mortality rates are expected to rise this year after a decadeslong drop, amid global cuts to health funding. In an interview with POLITICO’s Dasha Burns for “The Conversation,” Gates said his foundation has contributed to effectively halving the number of childhood deaths since its start in 2000, noting the plummet in deaths signified a “miracle” in global health care. (Wardwell, 12/3)
