HHS has submitted a peptide “interim access policy” to the White House Office of Management and Budget for review, according to a listing on OMB’s regulatory review site.
Here are five things to know:
- The filing does not describe the policy. Two people familiar with the plan told the Associated Press in an Oct. 15 report 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 approach is known as enforcement discretion, which would assure compounding pharmacies they will not be targeted for producing certain peptides, according to the AP. Formally adding peptides to the FDA’s list of drugs that can be compounded would require federal rulemaking, which could take years, and it is unclear whether the administration still plans to pursue that.
- Telehealth companies Hims & Hers and Noom have announced plans to offer peptides if the government eases access, and analysts estimate the market at $2 billion to $3 billion, according to the AP.
- The FDA had placed BPC-157 and more than a dozen other injectable peptides on its list of substances too risky for pharmacies to compound, citing possible contamination, allergic reactions and tumor growth. In July, an advisory panel recommended dropping the restrictions on six of seven peptides, against the conclusion of the agency’s own scientists, who said none had been studied enough to establish safety and effectiveness.
- The panel was selected by HHS and included several physicians, pharmacists and consultants who work in the peptide field. The agency reshaped the panel with industry advocates, and patients who say they were harmed by peptides have said their accounts are being drowned out as HHS moves to widen access.
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