For decades, the Food and Drug Administration was the undisputed global gold standard for regulation. While other nations might approve drugs faster or cheaper, an FDA approval was special. It was a guarantee that a product had survived a meticulous review by career scientists who were cautious to a fault and insulated from undue political influence.
During my 15 years at the agency — serving as a reviewer, special assistant to the commissioner, and founding director of the Office of Biotechnology — we understood that the agency’s legitimacy depended on a firewall between scientific evidence and political ideology.
Today, that firewall is not just cracking; it has been breached. Under the current administration, the FDA is being transformed from an independent regulator into a high-stakes bargaining chip for White House deal-making.
The rise of “horse-trading” regulation
One manifestation of this decline is the “Commissioner’s National Priority Voucher” program, launched in June by FDA Commissioner Marty Makary. The fiction is that it promises efficiency: Companies that align with the administration’s “national priorities” receive a “fast-track” review of just one to two months, compared to the standard 10 to 12.
But “national priorities” is a subjective term, and in practice, it has become a tool for political leverage. Final decisions on these vouchers are no longer the sole province of expert career staff. Instead, Makary has cleared selections with the White House.
Even more disturbing is the reported use of these vouchers as a carrot in pricing negotiations. The White House has allegedly dangled expedited reviews before companies such as Eli Lilly and Novo Nordisk in exchange for promises to lower drug prices. This isn’t regulation; it’s horse-trading. When the timeline for the evaluation of a drug becomes a reward for political concessions, scientific review becomes performative rather than determinative.
Speed as a weapon
The pressure to deliver on these “express service” timelines is destabilizing the agency’s internal mechanics. The case of one company’s GLP-1 diet drug application is an example. The company reportedly successfully pressured the FDA to shorten the “filing period” — the 60-day window before formal review that enables regulators to ensure an application is complete — to just seven days. That is recklessness masquerading as efficiency. The filing period exists to prevent reviewers from wasting time on sloppy or incomplete applications.
By ignoring these safeguards, the agency is forcing its staff to triage frantically, diverting resources away from other equally (or more) deserving treatments just to satisfy a political clock.
A culture of fear
Perhaps most corrosive is the “management by intimidation” currently taking hold. High-level leadership appointees, including Makary, head drug regulator Tracy Beth Hoeg, and head vaccine regulator and Chief Medical and Scientific Officer Vinay Prasad, have all signaled a shift away from established, rigorous science.
The environment inside the agency is now described by many as paranoid and fearful. In a recent memo to staff at the Center for Biologics Evaluation and Research, Prasad, its director, told dissenters who disagreed with his views to “submit your resignation letters.” When job security depends on compliance with the leadership’s “deals” and dubious decisions, independent scientific thought dies.
We are seeing the results in real-time. In the case of a new gene therapy for childhood deafness, career scientists raised valid safety concerns regarding the delivery device and the risk of meningitis. They were overruled: Two weeks later, a voucher was granted anyway, followed by public musings from the commissioner that the company might make the drug cheap or free. This is wishful thinking elevated to policy.
The cost of expedience
The administration justifies these moves by claiming it is dismantling “regulatory capture” by drug companies. The irony is staggering. In the name of fighting industry influence, it has created a system that invites it at the highest levels. Companies no longer just lobby review divisions; they lobby the commissioner’s office and the White House for “priority” status.
The FDA’s power has always derived from its restraint and its commitment to evidence. Once the public and the global medical community perceive the FDA as just another political office — no different than a trade negotiator — that unique authority evaporates.
Speed alone does not save lives; safe and effective drugs do. If we continue to trade the “gold standard” of evidence for the “fool’s gold” of political relationships, we will be left with an agency that moves fast but carries no weight. Once that trust is squandered, it may never be recovered.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished scholar at the Science Literacy Project. An official at the FDA for 15 years, he was the founding director of its Office of Biotechnology.
