US FDA Commissioner Nominee Not ‘Pro-Industry Choice,’ GLP-1 Compounding Could Be First Clash

Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.

Marty Makary
Martin Makary testifies at a Senate roundtable in September. (Screenshot)

Donald Trump’s plan to nominate Johns Hopkins surgeon Martin Makary for US and Food and Drug Administration commissioner may raise pharma industry concerns, in part because of his involvement with two drug compounding businesses, conflicts-of-interest that could impact a compounder-industry fight over GLP-1s that must be resolved soon.

More from US FDA

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."

Oncology Center Of Excellence Deputy Directors Kluetz, Theoret Join US FDA Exodus

 

The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department

 

About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.

Government Pulls ‘For Sale’ Signs From US FDA’s White Oak Campus

 
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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.

More from Legislation

Germany: Standardized Clauses In Clinical Trial Agreements Bring Opportunities But Also Tougher Negotiations

 

Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.

EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.

EU Pharma Reform: Negotiations Could See Patient Voice ‘Discarded,’ Warn Patient Groups

 

An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.