FDA advances peptide push to White House

The Big Story 

RFK Jr. advances peptide push

The Food and Drug Administration (FDA) this week submitted a peptide “interim access policy” to the White House for review, according to a government filing, which would reportedly allow compounding pharmacies to temporarily produce and sell previously restricted peptides. 

Greg Nash

Such a move would let these peptides on the market while FDA develops permanent rules, according to the Associated Press, despite a lack of evidence supporting their purported benefits. 

The FDA’s filing with the Office of Management and Budget did not give details on the policy, but it follows an agency advisory panel meeting this summer that voted to allow production of peptides to treat conditions like insomnia, obesity and wound healing.

Health Secretary Robert F. Kennedy Jr. describes himself as “a big fan of peptides” and has promised action to expand access to them. Kennedy said compounding pharmacies must be allowed to sell peptides because Americans are using unsafe, “gray market” versions of these drugs made in China and other countries. 

Pharmaceutical companies have brought several peptide drugs to market, including insulin. But the peptides the Health and Human Services Department (HHS) are interested in have not been tested or vetted by the FDA.  

The FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in July in favor of adding six peptides to the list of substances compounding pharmacies can make.

Those substances were among 14 that had previously been banned because of potential serious safety risks. 

The votes were split nearly evenly among the committee, and the decision to vote in favor of adding the peptides to the list went against FDA scientists’ evaluations. 

In briefing materials, agency researchers concluded that “based on the available data, there is a lack of evidence to make a conclusion on the effectiveness of BPC-157 for treating [ulcerative colitis]” and that current information “weighs against” adding it to the 503A compounding list.   

Staffers came to the same conclusions for all six peptides the committee approved, finding there wasn’t enough evidence to support adding any of them to the permitted compoundable substances. 

Welcome to The Hill’s Healthcare newsletter, we’re Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health.

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