RFK Jr. pushes FDA to approve controversial peptide drugs

The committee's vote on BPC-157 and other wellness substances revealed a split, with members whose terms began in April and May all voting in favor of the recommendation. Critics have argued that these members may have conflicts of interest that favor broader peptide availability. In contrast, longer-term participants and temporary members with academic backgrounds either opposed or abstained from voting.

Consumer advocates and the brand-name pharmaceutical industry have voiced concerns that permitting peptide compounding would bypass the FDA's clinical trial and approval requirements, potentially undermining incentives for drug development. Michael Stepanovic, a pharmacist on the board of the Collaborative for Evidence-Based Medicines, stated that such a move "would create a wide bypass for FDA clinical trial and approval requirements."

Ahead of the meeting, Rosebush's group suggested that the FDA's briefing materials were incomplete and did not fully incorporate new quality and manufacturing data they had submitted. Committee members questioned FDA staff on how their assessments were reached and whether the new information would be factored into the agency's final proposal. FDA officials confirmed that all information submitted by the comment deadline would be considered, with Russell Wesdyk of the FDA’s Office of Pharmaceutical Quality noting the volume of information staff had to analyze.