Peptide compounding empowers ‘charlatans,’ undermines safety

In a planned Federal Register notice, FDA has announced the convening of its Pharmacy Compounding Advisory Committee on July 23 and 24 of this year. At that meeting, committee members will consider whether seven peptides - injectable compounds often used for unproven benefits like improving injury recovery or building muscle mass - should be added to a list of products that can be compounded. Compounding is a process intended to provide personalized dosage forms of drugs to individual patients.

Today's announcement may well be Phase One in combating what HHS Secretary Robert F. Kennedy, Jr., characterized as a "war on peptides." Already, the administration is considering adding certain peptides to the list of products that can be marketed as dietary supplements.

The dangers to the American public cannot be understated. Not only would this unleash upon unsuspecting Americans a set of products previously deemed too dangerous to compound by the FDA, but it would also undermine the FDA drug approval process itself. What peptide manufacturer is going to conduct a multi-million-dollar drug research program and subject themselves to the rigors and uncertainties of the FDA drug approval system when they could simply start legally selling compounded peptides tomorrow?

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Dr. Peter Lurie is a former FDA Associate Commissioner.

Tags

• Food and Drug Administration
• Trump

Topics

• Government Accountability
• Supplements