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Jump to Key Points Oct 15 (Reuters) - The US FDA on Thursday submitted a new policy change that could allow pharmacies to more easily compound certain peptides to the White House for consideration.
Telehealth company Hims & Hers Health had previously said it plans to offer peptides if regulations permit.
Advisers had recommended the US Food and Drug Administration loosen restrictions on six of seven peptides under review in July, including the popular BPC-157.
Peptides — used for everything from pain to muscle recovery to beauty — have been promoted by social media influencers and Health and Human Services Secretary Robert F. Kennedy Jr. They are drugs built from short chains of amino acids, the same building blocks the body uses to make proteins.
- FDA submitted interim access policy for certain peptide compounding.
- Policy may ease pharmacy compounding of selected peptides.
- Six of seven reviewed peptides reportedly favored for looser restrictions.
- BPC-157 among peptides under consideration; not FDA-approved.
- Peptides are used for pain, muscle recovery, and beauty; use ↑ via social media.
The ones under consideration have not been approved by the FDA as safe or effective. Compounding pharmacies are allowed to mix ingredients of approved drugs in specialized doses and other under circumstances.
The Department of Health and Human Services and the FDA submitted an "interim access policy for compounding using certain peptides" for White House review, according to a filing on the Office of Management and Budget's website. The filing does not provide any details of the policy.
The Associated Press, citing two people familiar with the matter, said that it would allow them to make some popular peptides, including BPC-157, which is also known as Wolverine. Despite not being approved by the FDA, its use is soaring.
Hims & Hers and the Department of Health and Human Services, which oversees the FDA, did not immediately respond to Reuters' requests for comment. An administration official declined to comment.
(Reporting by Sahil Pandey in Bengaluru, additional reporting by Amina Niasse in New York and Yasmeen Abutaleb in Washington; Editing by Shilpi Majumdar)
