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

 
• By Sarah Karlin-Smith

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)
Key Takeaways
  • Donald Trump's announcement of his intent to nominate Martin Makary for FDA commissioner could set up a clash between the agency and industry over compounding policies, particularly related to GLP-1s.
  • The scope of Makary's financial divestments and recusal may impact whether compounding is a make-or-break issue for pharma and the nomination.
  • Makary is seen as less industry-friendly than other recent commissioners, but not necessarily anti-industry.

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...

Makary’s work with the companies also may highlight his beliefs about drug manufacturing and regulation in the US, which could conflict with the traditional role of the FDA.

More from US FDA

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

More from Legislation

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.