FDA scientists oppose HHS plan to ease access to unproven peptide drugs
Most FDA scientific staff members opposed a Department of Health and Human Services policy released Wednesday that would allow easier US access to unproven injectable peptides.
Staffers warned against policy change
Six people familiar with the development told the Associated Press that FDA drug staffers pushed back against the move. These employees warned the plan could undermine the agency mission of keeping unproven health products off the market. The scientists had limited input in drafting the final policy document.
Policy targets specialty pharmacies
The new directive tells the FDA not to take action against specialty pharmacies selling a half-dozen wellness peptides. These chemicals include BPC-157, TB-500 and KPV, which are promoted for building muscle and healing injuries. Under current rules, those substances would be considered illegal drugs because they lack rigorous safety reviews.
Industry promotes specific compounds
The wellness industry advocates for these injectable peptides to boost energy and support metabolism. Some of the chemicals occur naturally in the human body to trigger growth hormones. Drug companies have been developing these products without completing the standard approval process.
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