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Hahn Confirmation Hearing: Solid Performance Light On Substance

 
• By Derrick Gingery

US FDA commissioner nominee Stephen Hahn does not offer much detail on his policy positions; Senate confirmation could be completed by the end of the year.

Stephen Hahn, President Trump’s nominee for commissioner of the FDA, at his Senate confirmation hearing
FDA Commissioner nominee Stephen Hahn waits for his Senate confirmation hearing to begin. • Source: Derrick Gingery

US Food and Drug Administration Commissioner nominee Stephen Hahn kept his answers to Senators questions vague, sometimes irritatingly so, during his Senate confirmation hearing, and emerged largely unscathed from the 20 November event.

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What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

More from Agency Leadership

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.

US FDA Commissioner Rejected Some Proposed Reorg Plans

 
• By Elizabeth Orr

FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.