Q&A - November 3, 2025
This week’s questions:
Any initial thoughts on CDER Director George Tidmarsh’s response to being accused of abusing his office?
Your column on national uniformity and federal preemption (here) was critical of both industry and consumer advocates who are involved in the fight over food ingredient safety. Did you wind up in hot water?
The FDA’s newly-announced reforms of the approval process for biosimilars are being greeted with both plaudits and yawns. Which is the correct response?
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Q: Any initial thoughts on CDER Director George Tidmarsh’s response to being accused of abusing his office?
A: Dr. Tidmarsh’s ouster as CDER director is still an evolving news story with inconsistent narratives and unsubstantiated “facts.” Additionally, it is unclear whether he is on administrative leave or has resigned.
Weeks ago, Dr. Tidmarsh used a social media platform to issue non-neutral public comments on products and sponsors under FDA review. He later removed his post and stated that the prior comments were personal to him and did not reflect CDER’s views. That post is now also part of a lawsuit against Dr. Tidmarsh that claims he abused his office.
The post was a no-no. It undercuts FDA’s positioning as an agency that makes fair decisions and does so impartially and objectively. Furthermore, it seems odd for a federal official to express personal views — rather than those of the agency — on issues and product reviews within their own purview.
So far, Dr. Tidmarsh’s response has been to deflect. He has stated that the current investigation is a consequence of his opposition to the Commissioner’s voucher program and his disagreement with Dr. Prasad’s leadership.
Regardless of how you feel about those two other controversies, neither is relevant to an evaluation of whether Dr. Tidmarsh abused his office. Let’s not obfuscate these separate issues.
Q: Your column on national uniformity and federal preemption (here) was critical of both industry and consumer advocates who are involved in the fight over food ingredient safety. Did you wind up in hot water?
A: For those who may not have seen the column here, I explored the history and rationale for national uniformity in food and drug regulation.
In areas of FDA’s jurisdiction in which state legislators and governors want to become involved, federal preemption is often necessary. National uniformity sustains a level-playing field among various producers and manufacturers and assures that all Americans benefit from the consumer protections that the agency provides
I strongly favor national uniformity--it is the key to FDA’s success as a regulatory agency. Some readers viewed this as aligning me with a recently launched industry initiative in favor of preemption (here). I indeed oppose the burgeoning number of state laws that relate to food ingredients and additives. However, as I tried to make clear, the issue is more complicated, and my support is far from absolute.
Consumer advocates have turned to the states exactly because FDA has made little progress over the last 30+ years in establishing a regulatory framework that provides for the reliable, timely, and scientific assessment of food ingredients (both those currently used and those planned for the future). Working with state legislatures and governors has often been the primary means for consumer advocates to gain significant attention.
Even if preemption is justifiable in principle, it still needs to be earned — by ensuring that the salient issues being raised at the state level are considered at the federal level.
At first glance, the industry’s newly launched preemption campaign doesn’t reflect much appetite for serious and profound changes in federal food policies and processes. We need industry players to engage in a far broader discussion.
Also, a robust federal program addressing ingredient safety will be costly. It would help if the industry were open to paying user fees to offset some of the costs (here).
If industry and consumer advocates continue to fight each other, I predict a stalemate in Congress. Courts will then decide — probably inconsistently and without providing a framework for progress.
Arguing for consumer advocates to be more open to national uniformity and for industry to accept the need for deeper reforms.... probably does get me in hot water. And I would be thrilled to discover others are willing to join me there.
Q: The FDA’s newly-announced reforms of the approval process for biosimilars are being greeted with both plaudits and yawns. Which is the correct response?
A: Biosimilars are important clinically and have the capacity to shift billions of dollars away from off-patent branded biotech medicines into less expensive (but not inexpensive) biosimilars.
The reduction in testing requirements proposed by FDA makes sense in most cases. As far as I can tell, FDA doesn’t lose its discretion to ask for more tests whenever it feels that biosimilarity has not been fully established.
Taken in its best light, the new reforms should lower investment costs and shorten time to approval (hence the plaudits). On the other hand, a significant impediment to investment is the difficulty existing biosimilars face in gaining market share. That relates to formularies and rebates, which fall outside the FDA’s jurisdiction (hence the yawns).
Sara Koblitz of the Hyman, Phelps law firm has an excellent summary of the changes here.