Fda

Food and Drug Administration commissioner’s decisions have hurt staff morale and put his job in crosshairsDonald Trump has signed off on a plan to fire Marty Makary, the commissioner of the US Food and Drug Administration (FDA), the Wall Street Journal reported on Friday, after a series of high-profile agency decisions put the FDA head in the crosshairs of the White House and Republican lawmakers.Makary’s tenure at the FDA has been marked by several controversial decisions on drugs and vaccines amid plummeting staff morale over layoffs and the appointments of divisive officials. Recent political clashes include abortion, drugs and vaping, but decisions to pull back publications on the safety of shingles and Covid vaccines, among other immunization decisions, have also rocked public health. There have also been concerns about the transition from two clinical trials to one, the commissioner’s new priority review vouchers and “data-free” regulatory decisions. Continue reading...

• FDA announced new enforcement actions targeting compounding pharmacies producing GLP-1 drugs like semaglutide amid safety concerns. • The crackdown addresses risks from unapproved versions of weight-loss and diabetes medications flooding the market. • This policy shift aims to protect patients from potential contamination and dosing errors in the booming $100 billion GLP-1 sector.

Serious side effects from vaccines were rare, scientists found in studies funded by US taxpayer moneyThe US Food and Drug Administration has blocked the publication of several studies that found Covid-19 and shingles vaccines to be safe, according to a spokesperson from the Department of Health and Human Services.Agency scientists conducted the studies by analyzing millions of patient records and found that serious side effects from the vaccines were rare, the spokesperson confirmed. The studies – funded by taxpayer money and costing several million dollars – included research examining the safety of Covid-19 vaccines in 2023 and 2024. Continue reading...

• President Trump issued an Executive Order directing the Department of Health and Human Services to expedite access to treatments for patients with serious mental illness. • The FDA is accelerating its review process for mental health therapies in response to the directive. • This policy shift aims to reduce barriers to treatment approval and expand therapeutic options for affected patients.

• The FDA announced it will issue national priority vouchers for three psychedelic drugs next week, marking the first time the agency has fast-tracked any psychedelics for review under Trump's executive order on mental health reform. • The vouchers can compress FDA review timelines from several months to just weeks, according to FDA Commissioner Marty Makary, if the drugs align with national priorities. • Trump's order directs $50 million in federal funding to states developing psychedelic treatment programs and establishes a federal-state partnership for technical assistance and data sharing.

• The FDA announced the first ibogaine investigational new drug application as part of Trump's mental health executive order accelerating psychedelic drug approvals and research pathways. • HHS will coordinate with the FDA and DEA to expedite research approval and clinical trial access for emerging mental health treatments under strict medical supervision and scientific oversight. • The initiative specifically targets treatment-resistant conditions and addresses mental health needs among veterans and patients who have not responded to conventional therapies.

• FDA ties multistate E. coli outbreak sickening multiple individuals to cheese made with unpasteurized raw milk. • Highlights risks of raw dairy products in public health alerts. • Investigation ongoing to prevent further cases amid rising food safety concerns.