The Nominee for FDA Chief Wants to ‘Go Fast.’ Peptides Can Speed Biologic Competition

W ashington rarely hears a nominee to lead a regulatory agency say that the agency is the problem. Dr. Heidi Overton, President Trump’s pick for Food and Drug Administration commissioner, said exactly that at her Senate confirmation hearing on September 24: “Slow and prohibitive requirements for cutting edge therapies at the FDA means investment is increasingly flowing to China.”

She promised to make the FDA “the agency of the possible rather than the impossible,” to use “all of the statutory authority we can” to speed treatments for rare diseases, and to “make sure every aspect of clinical trials and drug development is optimized.”

This is the right diagnosis. Regulatory delay is not a costless safety margin. Every year that a much-needed drug waits for approval is another year lost to illness that patients never get back, and every dollar of needless compliance cost is a dollar not spent on the next discovery. Overton, a physician who served in both Trump administrations, understands that the FDA’s errors of delay or omission are deadly even if they never make headlines.

If Overton wants a place to show what “go fast” means, there is an area where she can do just that while simultaneously fulfilling another major achievement: advancing the president’s goal of lowering drug prices.

A new type of American-developed drugs, oral biomimetic engineered (synthetic) cyclic peptides, or eCPs, can in some cases replicate the therapeutic function of an injected biologic in pill form (biologics typically must be injected) without replicating its complex structure.

U.S. companies such as Johnson & Johnson, Merck, and Protagonist Therapeutics are leading the way, and others like Gilead are following fast. Two eCPs, Lipfendra and Icotyde, were just named two of Time magazine’s “Best Inventions of 2026.” A streamlined pathway for eCPs that are designed to act on the same well-understood biological target or pathway as an existing biologic medicine, but only ones whose patent exclusivity has expired, and can provide quicker price relief for patients by a new source of competition and by making the targeted care of a biologic medicine more accessible to rural communities by replacing travel to health centers for treatment with mail-ordered pills.

The stakes are large. About 90 percent of U.S. drug prescriptions are for off-patent medicines. So-called small molecules, which are typically pills dispensed by pharmacies, have generics that are much cheaper in the U.S. than abroad because of the intense price competition that patent expiration unleashes. But biologic medicines —the injectable, large-molecule drugs often administered by doctors — tell a different story. When their patents and exclusivities expire, “biosimilars” meant to drive down prices typically arrive at smaller discounts because of less competition among them than for generics. Patients and taxpayers foot the bill for medications that, after patent expiration, should be much cheaper, as small-molecule generics are.

Increasingly, the therapeutic advantages that some biologics provide can be delivered as an eCP, which follows more closely the way that small-molecule pills are made. Chemistry lets manufacturers deliver large-molecule benefits with small-molecule tools: precise, reproducible, and well-characterized. But regulation has not kept up with the chemistry. A faster, simpler pathway for synthetic peptides should be part of Overton’s regulatory-modernization agenda. Lawmakers, the FDA itself, and outside scientists have already put forward ideas. Three stand out.

First, launch an FDA demonstration project for engineered cyclic peptides (eCPs). These “biologics in a pill” could transform treatment by offering lower-cost alternatives to injectable biologics after patent expiration. The FDA already uses a fit-for-purpose approach to regulatory decision-making when it applies existing knowledge, prior clinical experience, and other relevant evidence from approved medicines to avoid unnecessary duplication and streamline development for novel medicines and indications. The FDA’s approach to biosimilars shows how this can work: In October 2025 the FDA proposed that most biosimilars no longer need costly comparative efficacy trials, relying instead on analytical comparisons without clinical trials. The ask is for a specific demonstration project to apply this approach for eCPs so that they can fulfil their potential as soon as possible for patients and the U.S. economy. The first eCP aimed at a given target would still need rigorous, product-specific evidence of quality, safety, and effectiveness. But expansions to new indications for eCPs should follow the quick pathway that is present for biosimilars.

Second, clear the regulatory path to bring drug manufacturing home. The FDA’s PreCheck pilot helps companies build new U.S. drug factories. But bringing manufacturing home also means moving production into existing U.S. plants. For well-understood products and processes, the FDA should reduce up-front testing where scientifically justified and combine overlapping inspections wherever possible. That would help bring high-value production, including chemical peptide synthesis, back to America faster — without lowering quality standards.

Third, clear the path for generic competition when an approved eCP’s exclusivity expires. The FDA should make the generic route the default for synthetic copies of eCPs when sameness can be established. A 2021 FDA guidance already lets companies file abbreviated generic applications for synthetic versions of five peptides first made in living cells, including glucagon, liraglutide, and teriparatide. Industry analysts read it as a sign that “chemical synthesis could be the regulatory default for this drug class.” The FDA should extend that approach to any synthetic peptide that can be shown to match its reference eCP product after exclusivity. As regulatory science and experience grow with eCPs designed to match an existing biologic, the FDA should consider further opportunities to streamline the required evidence packages and regulatory decision-making for approval.

None of these steps lowers the safety bar. Each replaces a costly ritual with better science, the very trade that Overton described when she said “frontier science doesn’t matter if it’s not accessible to patients.” Faster entry of eCPs would bring more effective competition after exclusivity to some of the most expensive drug classes in America. It would also bring manufacturing home, answering her warning that America is losing biotech investment to China.

Overton’s deregulatory perspective is welcome and long overdue, and her initial reforms should include peptides.