A plan to give Americans easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with the policy’s development.
The document, which covers certain injectable peptides popular within the wellness industry, recently underwent regulatory review at the White House, typically the final step before publication.
The effort on peptides, driven by Kennedy’s Department of Health and Human Services, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency’s longstanding mission of keeping unproven health products off the U.S. market, according to people familiar with its development.
The policy would direct the FDA not to take action against specialty pharmacies that sell certain widely used peptides—substances that would otherwise be considered illegal drugs because they haven’t gone through the agency’s rigorous review process for safety and effectiveness, according to three of the people.
The people spoke to The Associated Press on the condition of anonymity to discuss confidential government deliberations. An HHS spokesperson did not immediately respond to requests for comment.
Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.
The chemicals subject to the new policy haven’t gone through that rigorous vetting process. They include BPC-157 and TB-500, which are promoted to help heal injuries and build muscle.
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