美国HHS将肽类“临时准入政策”提交白宫OMB审查，拟允许复方药房配制BPC-157等热门肽类

WASHINGTON — U.S. health officials are moving ahead with a plan to allow specialty pharmacies to produce certain peptides, a class of largely unregulated injections that have become popular among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
Kennedy’s Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to a posting Thursday on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations with the potential for significant economic impact.
HHS officials did not immediately respond to requests for comment Thursday afternoon.
Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.
But the ones at issue here haven’t gone through that rigorous vetting process. Nevertheless, they have gained a foothold among Americans interested in bulking up, looking younger or boosting energy. Those uses are not approved by the Food and Drug Administration and most of the data on peptides comes from animal studies.
Before joining the administration, Kennedy publicly declared that “FDA’s war” on peptides and other wellness products would soon end.
After becoming health secretary, Kennedy said U.S. compounding pharmacies must be allowed to sell peptides because Americans were increasingly turning to “gray market” peptides made in China and other countries. Those products remain widely available for purchase via online platforms like TikTok.
The White House filing doesn’t give specifics of the new policy, but two people familiar with the plan say it is intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157, a chemical promoted to build muscle and heal injuries. The people spoke on condition of anonymity to discuss confidential government deliberations.
The update is the latest indication that Kennedy and other Trump administration officials are looking to ease access to unproven products that are popular within the Make America Healthy Again movement. Some of the biggest MAHA figures sell peptide injections and supplements.
The FDA previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances that are too risky to be compounded by pharmacies. Possible risks include contamination, allergic reactions and tumor growth, according to the FDA.
But earlier this year, Kennedy directed the agency to reconsider a short list of chemicals that have been widely promoted by wellness influencers and fitness celebrities.
In July, a panel of external FDA advisers recommended the agency drop its restrictions on six of the seven peptides put before them. That recommendation went against the scientific conclusion of FDA’s staff scientists, who reiterated that none of the peptides had been studied enough to establish their safety and effectiveness.
The new policy sent to the White House would essentially assure compounding pharmacies — specialty businesses that mix customized medications that aren’t available from traditional drugmakers — that they won’t be targeted for producing certain peptides, according to the people familiar with the plan. That approach, known as enforcement discretion, allows the FDA to selectively choose to not enforce some of its own regulations.
Formally adding the peptides to FDA’s list of drugs that are safe for compounding would require federal rulemaking, a process that could take years and involves multiple rounds of public comment. It was not immediately clear if the administration still plans to pursue that process.
The proposal was quickly praised online by some Kennedy allies who sell peptides.
“This is huge,” Brigham Buhler, a wellness clinic operator who sells peptides through an online service, posted on X. “This isn’t about whether you’re for or against peptides. It’s about whether you’re for or against MEDICAL FREEDOM.”
The panel of outside experts that met in July was selected by Kennedy’s health department and included several doctors, pharmacists and consultants who work in the peptide field.
The peptide business has caught the attention of major telehealth providers, including Hims & Hers and Noom. Both companies recently announced plans to offer peptides to their customers if the federal government eases access. Wall Street analysts estimate the market could be worth $2 billion to $3 billion.
— Matthew Perrone
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