The Pink Sheet

Recent and Upcoming US FDA Advisory Committee Meetings Recent and upcoming FDA advisory committee meetings and a summary of the topics covered. The FDA's oncologic drugs and pharmacy compounding panels have meetings scheduled. (Shutterstock)

President Trump announced Sara Brenner’s appointment along with his nominee for Centers for Disease Control and Prevention director. More HHS leadership shifts coming ahead of the mid-term elections. (Shutterstock) Key Takeaways FDA Principal Deputy Commissioner Sara Brenner was named senior counselor for public health at the Health and Human Services Department. The Trump Administration continues adding to the senior advisory staff around Health and Human Services Secretary Robert F. Kennedy Jr....

Information in the published literature “seems promising” to support using the products for low libido in men with idiopathic hypogonadism, the agency said, inviting interested sponsors to seek its advice on the data needed to support a broader indication by April 30. Published literature supports using testosterone therapy for low libido due to idiopathic hypogonadism, the FDA said.

Health and Human Services Secretary Robert F. Kennedy Jr. said criticism of FDA Commissioner Martin Makary stems from industry anger over tougher evidentiary standards. RFK Jr. defended FDA Commissioner Martin Makary's record during a House Ways and Means Committee hearing. (Screenshot of Committee Broadcast) Key Takeaways Rep. Darin LaHood, R-IL, warned that inconsistent FDA review decisions risk driving biopharma investment overseas, particularly to China.

The US FDA’s rapid approval of Lilly’s new weight loss brand Foundayo is the highest-profile use of the new Commissioner’s National Priority Voucher pathway and while the accelerated launch timeline is worth a lot, it comes with a cost. The current rate for traditional priority review voucher sales could help quantify the value of a CNPV.

The FDA’s Pharmacy Compounding Advisory Committee review of peptides is an early policy step, but rulemaking and manufacturing constraints may delay its impact. An FDA advisory committee will consider lifting restrictions on some peptides after the agency restricted them in 2023.

The Haystack Project is urging the FDA to swap ad hoc flexibility in rare disease trials for a clear, durable framework that embeds scientific rigor in a disease-specific context. The Haystack Project called for the FDA to clarify a route for rare disease flexibility instead of handling it case by case.

The new modulated approach to regulatory data protection under the EU pharma reform package sets a “high threshold” compared to the current framework, with some “uncertainty” for developers, a lawyer from Covington and Burling explains.

Ads for Pfizer's lymphoma drug fail to adequately communicate the indication and omit important risk information, the FDA Office of Prescription Drug Promotion said in one of three recent untitled letters that focus on overstatement of efficacy and understatement of risks. Facebook ads for Pfizer's Adcetris are false and misleading, the FDA said.

The vetting of ophthalmologist and cable news pundit Houman David Hemmati, who is a biotech company founder with big pharma industry experience, to head CBER could signal a shift in FDA thinking about the center director credentials. Houman David Hemmati, right, is reportedly a candidate for CBER Director. He has made several appearances on Fox News.