Welcome to FDA Matters

FDA Matters subscribers often start their week with my Q&A Monday column. To join them, you can subscribe (free) at www.fdamatters.com.

A substantial amount of new information surfaced during the often quiet Thanksgiving week, so I wanted to share an edited and updated version of yesterday’s (December 1) Q&A column.

This column addresses four issues:

• Commissioner Makary’s standing with the White House and HHS and what would likely happen if he quit or was pushed out,

• food policy priorities and the relative lack of urgency on hunger and food safety relative to other goals,

• Dr. Pazdur disagreements with the Commissioner and why it has resulted in today’s retirement announcement, and

• CDC’s implied support of a vaccine/autism connection and how anti-vaccine efforts have now spread to FDA.

Steven’s Traditional Thanksgiving Message to the FDA Stakeholder Community

This week, many of us will be sitting down to a Thanksgiving dinner and talking about the parts of our lives for which we are grateful.

Consider adding thanks to FDA and its more than 15,000 diligent and dedicated staff. Because of them, we have confidence when we sit down for a meal or use a drug or medical device…. 

HAPPY THANKSGIVING TO ALL

Dr. Pazdur understands that--in this Administration---his becoming CDER director is not an endorsement of the status quo or a mere mandate to stabilize CDER leadership. He will have to deliver on the promises Commissioner Makary has made, including substantially reducing review times, integrating generative and performative AI into all CDER activities, invigorating orphan drug development, and embracing the National Priority Review Vouchers.

None of this is beyond Dr. Pazdur’s experience or prodigious leadership skills. The challenge will be to demonstrate to Commissioner Makary that “continuity and carefully-chosen precedent” are the friend, not the enemy, of the Commissioner’s ambitious agenda.

‍Since the start of Trump’s second term, the agency has experienced significant losses in staff, capacity, morale, and respected leadership. We do not know whether the situation will improve from here or continue on a downward spiral.

FDA workers need a reason to stay, and job seekers need a reason to want to work at the agency.

‍When it comes to food and medical products, FDA is our nation’s Department of Homeland Security. FDA needs to be funded and staffed at a level that reflects our vulnerability and the potential consequences. The threat is both domestic and foreign; we need support for systems that are effective in protecting us from both sources....

Very few Americans appreciate the challenge faced by FDA....[As I have discovered] even long-time FDA-watchers don’t understand the strength of the motivation or the size of the profit that is derived from cutting corners on product quality or otherwise evading FDA regulation.