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The FDA touches nearly every part of daily life, from the food we eat to the medicines we rely on and the medical products that support patient care. At a moment of significant leadership change, staffing reductions, evolving enforcement priorities, and rapid adoption of AI, questions about the agency’s stability and direction matter not only to regulated industries, but to the public as well.
I recently spoke with Wayne Pines, a former FDA official and longtime observer of the agency, about what this transition means for consumers, life sciences companies, and the future of public health regulation. In our conversation, Wayne shared his perspective on FDA leadership, industry uncertainty, prescription drug promotion, AI, staffing challenges, and why trust in the agency remains essential.
As Wayne put it, “What we want is an FDA that is predictable and certain.”
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Tim: Thanks for sitting down with me today Wayne. A lot is going on at the FDA, so I guess my first question is why should we care about what's going on right now?
Wayne: We should care from two aspects: One is as consumers; FDA affects us every single day. We want – actually, we need - our foods and cosmetics to be safe. We want and need our drugs and medical products to be safe and effective. We need clear tobacco policies. FDA regulates products that account for 20 cents out of every consumer dollar. We expect the products we buy and use to meet safety and when appropriate effectiveness standards. FDA is an absolutely essential element in that process.
Secondly, from a business standpoint, the country needs a strong, predictable, and reliable FDA. Again, this is basic. Food companies must meet national standards to assure the quality of their products. Medical product companies invest millions or billions in manufacturing facilities and in product development, and they need to be able to rely on FDA to set uniform, enforceable rules. When we have a change at the FDA in policies, in oversight, in enforcement, it makes it difficult for our essential industries to function and to plan ahead. Change and uncertainty discourages innovation, investment, and product access, and eventually lead to a loss of consumer and public trust.
So what FDA does is extremely important to each of us individually, to our health and medical care and daily functioning. We often take FDA for granted, but everyone of us is invested in having an effective FDA.
Tim: Marty Makary just stepped down as commissioner and Kyle Diamantas is now acting commissioner. How often does this type of changeover occur?
Wayne: Lately, FDA commissioners usually have stayed in office about two years. In this case, however, we have an unusual situation. We have a president and a secretary of HHS with deep interests in what FDA is doing. President Trump learned a lot about FDA during his first term when the pandemic emerged, and in his second term he has expressed views about FDA decisions. Dr. Makary, I think, spent more time at the White House and standing next to President Trump than any previous commissioner.
There are other things that make the current situation unusual for FDA. Dr, Makary sought a high profile. With one or two exceptions FDA commissioners do not seek high profiles. Plus, while Dr. Makary made some fundamental changes at the agency, many of them are not backed up by regulations or even guidances and thus can be changed by new leaders. That undermines predictability.
One more fundamental change is that the agency has 4,500 fewer employees at FDA now than a year ago and much of the memory and expertise has left. That obviously affects the way that the agency functions.
Adding to unpredictability is that many senior FDA leaders have just been replaced -- the heads of the Center for Drugs, for Biologics, the Chief of Staff, and a number of other people have just left. There's going to be a new head of the Human Food Program because the previous head, Mr. Diamantas, is now the acting commissioner. So, this is an unusual transition.
FDA is accustomed to changes in leadership and is adjusting to the current environment. The work is getting done. But now we face another transition, and we are still awaiting to see whether there are further changes in policy or in direction. Again, what we want is an FDA is predictable and certain. And when you have a change in leadership, you have to question whether that certainty and predictability is going to be maintained.
Tim: Are there any particular policies we should be focused on?
Under Dr. Makary there were changes throughout the agency, but especially in the pharma area, because that is where Dr. Makary initiated a lot of new policies. Examples include the voucher program designed to expedite the approval of significant new drugs; the single-study standard for new drug approvals; the Pre-Check program for new drug manufacturing facilities; and the one-day inspection program under which many inspections – not just pharma - are conducted in a single day. The drug industry in particular is watching to see which of the changes instituted are maintained.
We need a strong and innovative drug industry in the U.S. and these policies are central to new drug development. We can’t have a strong and innovative drug industry without a strong and innovative FDA.
Tim: With Kyle Diamantas coming from the food side, what should the pharma industry think about someone from that side of the agency coming into a leadership role?
Wayne: Mr. Diamantas does have a diversity of experience that makes him a good choice for acting commissioner. Under his management, the food program has had clear direction for the past year, even with the reduction in force. Mr. Diamantas gets favorable marks from many of the people who work for him.
I'm optimistic that during his presumably temporary tenure as acting commissioner, he will provide leadership not just in the food area, but across the entire agency, and hopefully the pharma and other regulated industries can count on him to make sound judgments and rely on good scientists whenever a medical decision is needed.
One footnote to his appointment. Mr. Diamantas is an attorney. Many if not most in the FDA community think that the commissioner must be a physician or a PhD in a biological science. So that's one of the things that people are watching. My own view is that what is needed now is a good manager at the helm.
Mr. Diamantas is likely to serve as acting commissioner for many months, probably until the end of the year. It’s hard to see how they will be able to nominate and confirm a permanent commissioner this year.
Tim: Are there any expectations that the change in leadership could affect the way that the FDA approaches prescription drug promotion? There have been 75 untitled letters since last September and industry continues to adapt to an aggressive enforcement environment.
Wayne: We don't know. As you said, FDA is now engaged in an enforcement crackdown, especially on direct-to-consumer advertising and promotion. No new policies, but strict enforcement of existing policies and in many cases new interpretations of policies. Dr. Makary has been a leader in advocating for this crackdown, as has Secretary Kennedy. With Dr. Makary no longer Commissioner, we'll have to see whether that aggressive enforcement will continue.
My guess is that it will. Secretary Kennedy is still at the helm at HHS. And there’s been little dissent from the pharma industry to the stricter enforcement. OPDP - the Office of Prescription Drug Promotion - is now using AI to screen submissions and despite a much smaller staff is issuing an untitled letter virtually every week.
The new acting head of the Center for Drugs, Mike Davis, has been at FDA for some time and so, at least for the time being, he’s likely to support the current approach. If and when new permanent leadership emerges, we’ll have to see what promotional policies they favor. But my guess is that the current strict enforcement approach to pharma promotion, especially DTC, will continue.
One promotion area that will continue to evolve from a regulatory standpoint is social media. How will benefit and risk information be conveyed when space is limited? I think we’ll see still more enforcement with social media and the enforcement letters will help define what OPDP’s expectations are.
Tim: With everything that's going on now with AI and at the FDA, how do you think that might change in the next year?
Wayne: There is an ultra-active effort to use AI for all aspects of regulation and management -- product reviews, inspection scheduling and generally across the entire FDA. For example, 90 percent of the employees in the Center for Drugs are now using AI. Dr. Makary supported more use of AI on a routine basis, as did previous commissioners. We all know AI is here to stay in all of our lives. AI represents a fundamental transition for FDA as it is for all of us.
The potential benefits in time saving and efficiency are obvious. There also are downsides to be cautious about. AI is and never will be perfect. We all know that AI sometimes hallucinates, sometimes makes mistakes. For FDA, there's no margin for error. When you're in the hospital and you're looking up at an IV bag, there's no margin for error in terms of the quality of that bag, because that drug is going right into your vein. So, the FDA is going to have to be assured how they can use AI reliably and confidently.
What the regulated industries need to do is to understand the algorithms that FDA is using because there needs to be a correlation between the way that the industry develops and submits information and the way that FDA evaluates it. That's going to be a real challenge. But it's a challenge that we all have to has to meet in our daily lives. AI is the new reality of the world and I’m confident FDA will use it and regulate it successfully. There is no other option.
Tim: In your opinion, what are the most important jobs the FDA should be filling as soon as they can?
Wayne: The FDA has 4,500 fewer employees than they did on April 1st, 2025. They are in the process of hiring to fill the 1,000 or more vacancies that now exist. That’s going to take a long time. And the expertise they’ve lost will take even longer to replace.
In the pharma and medical devices area, FDA needs more medical reviewers including pharmacologists and chemists and manufacturing experts and engineers to be able to process applications and provide guidance to product developers. They need more inspectors – for example, there are half as many experts in infant formula facility inspections than there were a year ago. In virtually every area of FDA oversight, there will need to be many hires.
And all these people need to be trained, and the training takes some time. FDA work is often unique. You don’t learn how to inspect a manufacturing facility simply by going to school. So, it's not just a matter of hiring somebody and saying, go do your job. It's a matter of hiring them and saying, let's train you.
Tim: Given the fact that there are 4,500 fewer employees at the FDA now, should the public be concerned about the safety of our food supply and our drug and device and medical product supply?
Wayne: No, I think that the FDA continues to do the kind of job that the public expects them to. The employees are very, very dedicated. There's been no diminution, I think, in the safety of our food and drug supply. But we have to invest in the FDA to be sure that the same level of protection is maintained. Because again, we're all personally invested in what FDA does.
I spent 10 years at FDA. There have never been enough resources. When resources are squeezed, the staff just works harder and longer hours and work more efficiently and get the most important work done. And I think that's what we've been seeing.
The agency’s proposed 2027 budget is basically the same as 2026. With inflation, of course, it means that FDA in 2027 will have less what I call buying power. Anyone concerned about this should let their congressmen know how important it is to fund FDA and to appropriate enough funds for the agency to keep up with advancing technology and medical advances.
I’m optimistic that the FDA of the future will still be capable protecting us as consumers and also advance a scientifically sound public health agenda. But we in the FDA community need to continue to support the agency.
Tim: If we're looking at kind of a best- and worst- case scenario for the FDA over the next year, what do you think both of those scenarios could look like?
Wayne: I would hope that moving forward there's more stability at the agency. That the policies are clear, that there is more predictability and more certainty for consumers and for regulated industry. And I hope the massive brain drain will stop and well-trained and educated experts will want to work there. I also hope that the transition to AI is handled well – as I said before, in the FDA world, there is no margin for error when it comes to safety and quality of products we all take into our bodies.
We're in an election year now, and during an election year, most folks in the government want the FDA to be relatively quiet in terms of new policies. That's historically been the case. Mr. Diamantas has close connections to the White House. And with that support, hopefully, he'll be able to move FDA forward on a clear path.
Finally let me use the word “trust.” Trust is an important issue. The agency has lost a degree of public and industry trust, as has a lot of the public health establishment and the government. And not just on a national basis, but on an international basis. The public and the regulated industries need to be able to trust the FDA. The decisions made by FDA affect everybody daily. Hopefully, the new leaders will set that as a conscious priority.
Tim: Thanks Wayne, I appreciate the insight and the time.
