Pallone: Holding a Routine Hearing on User Fees While Trump Dismantles FDA is Irresponsible and Dangerous

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following opening remarks at a Health Subcommittee hearing on “Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs":

An examination of user fees for over-the-counter drugs is a discussion that we should have, were it not for the Trump Administration dismantling our public health infrastructure before our eyes.  

There is no logic in holding a routine discussion on user fees before understanding the Trump Administration’s plan, masterminded by the reckless, uninformed antics of Elon Musk’s DOGE, to slash the Food and Drug Administration’s workforce by an additional 3,500 public servants. It is hard to see how a drastic cut of nearly 20 percent of the total FDA staff will not impact the critical functions of the agency. The Administration is hemorrhaging our public health agencies and expertise within them while Committee Republicans silently sit by and watch. 

Let’s be clear what is happening here – the Trump Administration’s goal is to hollow out the agencies to find savings for their giant tax breaks for their billionaire friends, including Elon Musk himself. But it is also crystal clear that the administration is looking to get rid of those who refuse to bend to their anti-science agenda and medical quackery.  

Just last Friday evening, the Trump Administration pushed out Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research. Dr. Marks’s hand was forced by the Trump Administration’s unprecedented assault on settled science regarding vaccine safety and efficacy. As Dr. Marks correctly noted in his resignation letter, “truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”  

Democrats too have experienced the Administration’s disdain for truth and transparency as we have tried to obtain basic information from the Administration on the layoffs at HHS. HHS has refused repeatedly to provide an update on the status of its terminations, both those made in the first round and the additional 3,500 layoffs moving forward. The lack of transparency and stonewalling is unacceptable and let’s be clear—it shows that HHS knows that these terminations and the wholesale elimination of entire HHS operating divisions are indefensible and unlawful.  

Dr. Marks is not the first expert to be purged from the agency and I’m sure he is not going to be the last. The attacks continue yet our Republican colleagues refuse to demand answers or hold this Administration accountable. Today, Committee Democrats are once again demanding answers from the Administration about last week’s layoff and reorganization announcement, and we would hope that Republicans would finally recognize that it is time for them to start asking questions as well. After all, these actions could significantly impact the FDA’s job when it comes to over-the-counter drugs.

FDA regulates the drugs, medical devices, and cosmetics American’s use, the food they eat, and much more. FDA’s mission is to ensure the safety and security of these products before they reach consumers. I fear that the Administration’s forced layoffs at FDA will result in dangerous products slipping through the cracks while promising new products will face delays in getting to Americans.

I’m not the only one sounding the alarm. Industry experts have raised concerns that these terminations will delay timely patient access to products regulated by FDA by months, if not years, and impact surveillance efforts, including delayed inspections. Reports already show that since the first round of terminations, FDA has been struggling to meet Congressionally mandated deadlines as staff are being assigned double the number of new product applications for review. With a workforce stretched this thin, it seems inevitable that unsafe products will make their way into American’s grocery stores and medicine cabinets. 

And even though HHS claimed user fee reviews would not be affected, we’re hearing from industry that 50 percent of the positions eliminated will be user fee related. In his statement announcing these cuts, Secretary Kennedy said that this will be a painful period for HHS—unfortunately, this will also be painful for the health of the American people—especially if our Republican colleagues continue to refuse to conduct any oversight of this Administration’s unlawful and dangerous actions. 

While I hope we can look forward to a smooth reauthorization of this critical user fee program, I am disappointed that our Republican colleagues do not see the urgency in conducting oversight of the illegal terminations that will impact the very program they plan to discuss today, among many others. 

I yield back the balance of my time. 

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