FDA, HHS send peptide compounding policy to White House for review
Health officials sent the White House a policy that could let pharmacies make certain peptides, AP and Reuters reported. Two people familiar with the plan told AP it would let pharmacies make popular peptides such as BPC-157 for a time. The FDA has not approved these peptides as safe or effective.
Federal health officials have sent the White House a policy that could make it easier for pharmacies to compound certain peptides, a class of largely unregulated injections popular with wellness influencers, The Associated Press and Reuters reported Thursday.
Health Secretary Robert F. Kennedy Jr.'s Department of Health and Human Services submitted a peptides "interim access policy" to the Office of Management and Budget for review, according to a posting on a government website, AP reported. Reuters said the HHS and FDA filing, for an "interim access policy for compounding using certain peptides," gives no details of the policy.
Two people familiar with the plan told AP that it is meant to let pharmacies temporarily compound some of the most popular peptides, including BPC-157, which is promoted to build muscle and heal injuries. The people spoke on condition of anonymity, AP said.
The policy would essentially assure compounding pharmacies that they won't be targeted for making certain peptides, an approach known as enforcement discretion, the people told AP. Formally adding the peptides to the FDA's list of drugs that are safe for compounding would require federal rulemaking that could take years, AP reported.
The peptides under consideration have not been approved by the FDA as safe or effective, Reuters reported. The FDA previously put BPC-157 and more than a dozen other injectable peptides on its list of substances too risky for pharmacies to compound, citing possible risks including contamination, allergic reactions and tumor growth, AP reported.
In July, outside FDA advisers recommended loosening restrictions on six of the seven peptides they reviewed, both outlets reported. AP said that went against the conclusion of the FDA's staff scientists.
Telehealth company Hims & Hers has said it plans to offer peptides if regulations permit, Reuters reported. AP said Hims & Hers and Noom both announced such plans, and that Wall Street analysts estimate the market could be worth $2 billion to $3 billion.
HHS officials did not immediately respond to requests for comment, both outlets reported.
What we know: HHS and the FDA sent a peptide compounding policy to the White House budget office for review.
What we don't: Which peptides it covers, and when or whether it will take effect.
Where outlets agree AP and Reuters both report that HHS submitted an interim peptide access policy to the White House budget office and that outside FDA advisers in July backed loosening limits on six of seven peptides.
Where they differ The outlets cited here report the same key facts so far.