T4K3.news
FDA panels under Makary raise alarms about independence and bias
New ad hoc FDA panels prompt questions about independence, transparency, and how regulatory guidance is shaped.
Ad hoc FDA expert panels discuss controversial topics, prompting questions about conflicts of interest and regulatory standards.
FDA panels under Makary raise alarms about independence and bias
WASHINGTON, AP — The FDA has shifted from its trusted pool of formally vetted expert advisers to informal ad hoc panels. Led by Commissioner Marty Makary, the panels meet with physicians and researchers who often hold contrarian views or financial ties to the subjects, including antidepressants, menopausal hormones and talc safety. Critics say the format skirts federal rules on conflicts of interest and transparency, and risks shaping opinions that resemble advocacy more than expert consensus.
Follow-up sessions covered antidepressants during pregnancy and estrogen-based menopause therapies. In several sessions, panelists testified in related lawsuits or promoted positions linked to industry campaigns. While the FDA’s standard advisory committees operate under strict disclosure and public-comment rules, these newer meetings have not shown those safeguards, sparking concern that they could influence regulatory decisions or inform litigation rather than official guidance.
Key Takeaways
"These meetings are a chance to advance RFK’s pet peeves — talc, antidepressants, fluoride — with people who have been handpicked"
Lurie commenting on the intent behind the panels
"It’s never been possible to identify a group of people who do particularly well on antidepressants"
Dr. Joanna Moncrieff on antidepressant efficacy debates
"Hormone replacement therapy for women is basically a modern-day miracle"
Makary defining his stance on hormone therapy
"The best thing they can do for themselves and their baby is to get the treatment that they need"
Dr. Nancy Byatt on antidepressant treatment in pregnancy
The situation signals a shift in how the FDA sources outside input. By assembling handpicked experts who share views aligned with political rhetoric, the agency risks normalizing fringe claims as scientific consensus. That could erode public trust in regulatory science and invite legal challenges that question the process itself. The real test will be whether Makary’s approach leads to formal, transparent advisory structure or stays as informal forums with uncertain impact on policy.
This debate also highlights the broader tension between rapid assessment and rigorous governance. In a time of rising skepticism toward institutions, the FDA’s methods matter as much as the outcomes. If the agency wants to preserve credibility, it must restore clear conflict checks, publish panel selection criteria, and invite balanced, independent voices along with public participation.
Highlights
- These meetings stamp approval on predetermined opinions
- A balanced panel with conflicts checks and public participation is needed
- The information here could be used in litigation and presented as consensus
- Transparency would demand a public, balanced process
Risk of political influence and conflicts in FDA panels
The ad hoc panels raise concerns about conflicts of interest, lack of transparency, and potential political influence that could affect regulatory decisions and public trust.
Trust in health regulation hinges on clear rules and open channels, not private conversations around controversial claims.
Enjoyed this? Let your friends know!
Related News
FDA panel criticized for misinformation on antidepressants
FDA panel raises concerns about SSRI safety in pregnancy
New COVID variant Nimbus detected in the U.S.
Medical groups alert over RFK Jr. task force plans
FDA reappoints vaccine chief Vinay Prasad
Kennedy cancels mRNA research
Watchdog investigates ex-Trump prosecutor Jack Smith
Woman shares warning after severe complications from antibiotic
