Trump Administration Drafting Plan for Temporary Sale of Some Unapproved Peptides, Washington Post Reports

The Trump administration is crafting a plan that would allow the temporary sale of certain previously restricted peptides while federal health officials write new regulations, according to a Washington Post report citing two people familiar with the matter. Both spoke anonymously.

The plan has not been announced. Timing is unclear, and the Post's sources said it could still change. The Department of Health and Human Services did not comment.

What the plan would do

The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products. Many of the claims behind those products have not been fully safety tested.

Which peptides would be covered is unclear. The Post's reporting, as summarized elsewhere, says seven peptide treatments for conditions including obesity, insomnia and wound healing are under FDA review.

Peptides are short chains of amino acids. Some have become approved drugs, including the GLP-1 medications used for diabetes. The unapproved wellness versions, pitched by influencers as boosting longevity or physical performance, have spread through gray and black markets.

Health Secretary Robert F. Kennedy Jr. has called himself a "big fan" of peptides and has said he wants them more broadly available. The Post's sources said federal officials are looking at guardrails, including patient disclosures, adverse-event reporting and data collection.

The industry ask

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said his group has asked the FDA to use "interim enforcement discretion." Under that approach, the agency signals it will spend its enforcement resources elsewhere.

That would let state-licensed compounding pharmacies prepare the drugs for patients with a prescription. Brunner said he has met with the FDA twice and wants conditions attached: enhanced disclosures to patients, serious adverse-event reporting and data collection on peptide use.

"That's a much better approach than what we're seeing in the illicit markets," Brunner said.

The safety objection

FDA scientists and some medical experts have raised alarms about widening access. Their concern is that many of these products have never gone through the clinical trials required of approved drugs.

Career FDA scientists said in late June that the evidence was too weak to support compounding some of these peptides, according to the Post's reporting. That puts the agency's own staff on record against at least part of what the administration is now weighing.

The Post's own investigation found the FDA has struggled to keep pace with the market. State pharmacy, medical and nursing boards lack the authority and resources to oversee it, the investigation found. It documented peptides made in people's homes and labels naming manufacturing facilities that turned out to be empty office space.

Both sides are working from the same fact: an unregulated market already exists. The dispute is whether pulling it into licensed pharmacies reduces the risk or lends legitimacy to products nobody has proven work.

What a pilot would not settle

Enforcement discretion is not approval. It is a statement about what the agency will chase, not a finding that a product is safe or effective. Whether a pharmacy can guarantee sterility on products with no approved manufacturing standard is a question the plan, as reported, does not answer.

The Post also reported that a polling memo circulated by industry advocates argues expanded access carries political upside. That is an advocate's claim, and no administration official has been quoted endorsing it.

Medicaid drug prices

On a different front, President Trump announced Sept. 18 that all 50 states, the District of Columbia and Puerto Rico will join the GENEROUS Model. The program tests whether manufacturer-paid supplemental rebates can bring Medicaid drug prices in line with the most-favored-nation benchmark.

The White House Council of Economic Advisers projects more than $64 billion in savings over a decade, about $36 billion federal and $28 billion for states. Those are administration projections, not results.

Mississippi Gov. Tate Reeves said his state's Medicaid drug payments run nearly $7 billion a year, about 10 percent of state spending. CMS Administrator Dr. Mehmet Oz said the manufacturers of Eliquis agreed to donate 1 million free doses to state Medicaid programs.

What to watch

No signed order or formal FDA notice on peptides has been published. The next concrete step is whether the agency issues a notice defining which peptides are covered, for how long, and under what reporting conditions. Without that, the plan remains a draft described by two anonymous sources.