Embattled FDA Commissioner Marty Makary is testifying before the Senate Appropriations Committee next Wednesday (May 13), where he’s likely to face questions about how drug approval processes have been impacted by FDA’s leadership turnover, decline in staffing levels and controversial Commissioner’s National Priority Review Voucher program.
FDA stakeholders are questioning whether Makary will keep his job at the agency amid controversies over approval of flavored vaping products, regulation of abortion drug mifepristone, withholding of studies on vaccine safety, rare disease approval standards and more.
Senate appropriators will have the chance to ask Makary about any of those topics next week, along with FDA’s budget and Makary’s plans to hire 3,000 new scientists.
The latest controversy for the commissioner comes from reporting in Stat Wednesday (May 6) that drugmaker Sanofi has asked to pull its type 1 diabetes drug from Makary’s signature Commissioner’s National Priority Review program (CNPV) after acting drug center director Tracy Beth Hoeg got involved in the review and attempted to override reviewers’ decision to approve the drug. According to the report, Hoeg eventually asked for an advisory committee meeting on the issue; no meeting has yet been scheduled, and FDA has missed its April 21 goal date for a decision on the drug.
Sanofi’s teplizumab was part of the initial cohort of drugs in the CNPV pilot program for its potential to slow the progress of type 1 diabetes in children, but Hoeg’s safety concerns show that the program — touted as a way for companies to secure faster approvals on drugs that address high-priority Trump administration goals — can also result in political appointees becoming deeply involved in a review, an outcome some sponsors would likely prefer to avoid.
Rep. Jake Auchincloss (D-MA) has raised concerns that the CNPV program, which is not authorized by Congress, is illegal, and recently told Inside Health Policy, based on whistleblower reports he’s received from FDA, that Makary’s leadership has created a climate of “fear and retaliation.” Auchincloss also said he’s expecting Makary to face House oversight hearings this summer.
In response to the Stat story, Auchincloss said in a social media comment every manufacturer should pull its drugs from the program. A spokesperson for his office told IHP, “The congressman has long called this program a poisoned chalice. He has been clear that industry should not participate in this illegal program, and he encourages other companies to withdraw their drugs from consideration.”
At a Friends of Cancer Research event Wednesday, stakeholders said they hope more lawmakers will follow Auchincloss’ example by taking an interest in FDA oversight, citing the high staff turnover at the agency and a lack of consistency in drug reviews as issues concerning industry and investors.
Priti Hegde, senior vice president of Gilead Sciences blood cancer spinoff Kite, said predictability, clarity and consistency in the drug review process are “critically important” for industry and need to be addressed by FDA leadership.
https://insidehealthpolicy.com/daily-news/makary-may-face-tough-questions-senate-approps-hearing