The White House is reviewing a proposal to broaden access to compounded peptides with more patient protections than initially expected, according to an Oct. 22 Bloomberg report.
Here are five things to know:
- HHS has proposed setting temporary enforcement priorities that would let compounding pharmacies make certain peptides without being targeted, as long as they certify the substances’ identity and purity and report adverse events, according to Bloomberg. The proposal would not formally approve the peptides or establish that they are safe and effective. HHS and the FDA did not respond to requests for comment, and the policy could change.
- Requiring compounders to report serious adverse events would depart from existing rules, which generally do not require traditional compounding pharmacies to report negative side effects to the FDA. It could be hard to implement, since the FDA shares oversight with states that license and monitor pharmacies. A national group of pharmacy boards said this year it would develop a system for reporting and sharing adverse event information on compounded drugs.
- Officials have also discussed allowing the FDA to issue a proposed regulation recommending against adding certain peptides to the list of substances eligible for traditional compounding, which would leave current restrictions in place and match FDA scientists’ stated concerns. The policy would go through public comment before any final decision, and it is unclear what the final product could be.
- HHS Secretary Robert F. Kennedy Jr. has the legal authority to set the policy, though it would be unusual to override FDA officials, Bloomberg reported, and a former FDA lawyer said decisions like this have generally been made by FDA experts. Meetings on the policy at the White House include the Alliance for Pharmacy Compounding, Hims & Hers and the American Academy of Peptide Medicine, according to a public calendar.
- The FDA’s advisory panel voted in July to relax restrictions on six of seven peptides, contrary to the conclusions of agency scientists. The administration was preparing a stopgap policy on peptides as of Oct. 8, and HHS sent the plan to the White House for review Oct. 14.
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