Q&A - September 8, 2025
This week’s questions:
Is Secretary Kennedy at risk of losing his job?
What is Kenvue? Doesn’t J&J make Tylenol?
How realistic is it to dramatically shorten product review cycles?
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Q: Is Secretary Kennedy at risk of losing his job?
A: Many people were wondering this past week about Secretary Kennedy’s job tenure....what with stories about the MAGA/MAHA split and his rambunctious appearance before the Senate Finance Committee, where he drew negative feedback from three Republican Senators.
The hearing was political theatre (a great show IMO), and everybody played their roles well (here and here). Kennedy was self-assured and unyielding. Actual shouting matches in Senate hearings are rare, but there were several between Kennedy and Democratic Senators. He accused one of them of being “a liar.”
Despite the President’s claim not to have seen a tape of the hearing, I have to believe that someone at the White House created a highlight reel for the President, and that he was delighted with Secretary Kennedy’s performance. All by itself, that would suggest Kennedy has some job security, at least to the extent that any official in the Trump Administration can count upon having a firm grasp on their job.
Three Republican Senators were critical of Secretary Kennedy, perhaps suggesting to some that broader Senate opposition to Kennedy might be coming. At least for right now, I don’t see that happening. The bulk of Senate Republicans will still be looking to President Trump for guidance on vaccine policy, not to their state health departments.
The approach taken by the Republican Senators was an interesting one, mirroring an argument that Michael Bloomberg laid out in an op-ed last week (here) and which is based on a Trump remark. The goal was to get the Secretary on record saying that Operation Warp Speed (which stimulated the creation of the COVID vaccine) was a towering achievement of President Trump’s first term, worthy of a Nobel Prize. Kennedy agreed, but then went right back to bad-mouthing the safety, efficacy, and need for COVID vaccines.
As to the consequences of the hearing...you can’t judge the room by what was being said. It was political theatre. What matters is what Senators say to each other about Secretary Kennedy when the cameras aren’t rolling and no one else can hear. That still has to play out.
More than a guess but less than a prediction: Secretary Kennedy retains his position for now and continues his negative attitude about vaccines. The White House may force him to soften the attacks on COVID-19 vaccines, but probably not overrule him on the narrowing of the labeling.
Q: What is Kenvue? Doesn’t J&J make Tylenol?
A: Kenvue was created in 2023 by J&J spinning off its former Consumer Health Products division into a new company. It is the maker of dozens of consumer product brands, including Band-Aid, Neutrogena, Listerine, Aveeno, and Benadryl. More details are here.
Q: How realistic is it to dramatically shorten product review cycles?
A: FDA stakeholders and the agency--working together--have opportunities to shorten review times. It is, however, a complex situation, including concerns about budget and manpower needs. Numerous other trade-offs need to be discussed and resolved before comprehensive reform becomes possible. I plan to come back to this topic in the near future and devote at least one full column to it.
In the meantime, a good starting place is an explanation of the difference between real- and perceived-time savings. In their own ways, both can contribute to shorter reviews.
“Real-time improvements” would involve finding ways to increase productivity. If, for example, AI can accurately and reliably summarize a 500-page protocol in a day that would otherwise take a week, that provides a net gain in productivity and allows for the possibility that four days could be subtracted from review times.
AI aside, productivity gains might come from consolidating forms, eliminating duplicative steps in the review process, and changes in review flow or staffing. It is worth exploring Dr. Makary’s idea of compressing the final decision (not all of the work) into a noticeably shorter timeframe through an in-person meeting.
“Perceived-time improvements” would come from finding ways to move more of the agency’s and sponsor’s efforts so that they are carried out before Day 0 (when the NDA or BLA is submitted). Rolling review--where companies submit chapters of the application to FDA for review before submission--displaces some amount of time that the agency would otherwise have to expend during the 6–9-month review process.
In most instances, rolling review should generate perceived-time improvements relative to the submission date. It may also affect agency productivity, but I do not have the data to show whether rolling review takes more or less time and manpower than conducting the entire review after submission.
As noted, I will be writing more about “shorter review times” in the near future.