FDA Scientists Opposed HHS Plan to Ease Peptide Access

Most scientific staff at the Food and Drug Administration opposed a plan to give people in the United States easier access to unproven peptide drugs favored by Health Secretary Robert F Kennedy Jr, according to six people familiar with its development. They said agency scientists had limited input in drafting the policy.

The Department of Health and Human Services posted the document online on Wednesday. It covers a handful of injectable peptides promoted in the wellness industry for building muscle, healing injuries and boosting energy.

The sources spoke to the Associated Press on condition of anonymity because they were discussing confidential government deliberations. An HHS spokesperson did not immediately respond to a request 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, including mainstay treatments for diabetes and weight loss. The peptides covered by the new policy are not among the approved ones.

What the policy does

The policy tells the FDA not to act against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules those substances would otherwise count as illegal drugs, because none has gone through the agency's review for safety and effectiveness.

It is a step back from HHS's first plan, two of the people said. HHS officials initially wanted the FDA to write a formal regulation adding BPC-157 and other peptides to the list of substances deemed safe for compounding pharmacies. FDA officials warned that their scientists had major safety concerns and would not back a regulation calling the peptides safe. HHS then switched to directing the FDA not to enforce its rules against pharmacies that compound them.

FDA staffers did give technical help with the final text, including safeguards. Pharmacies must use ingredients from FDA-registered factories, collect information on side effects and verify the chemical identity of the peptides, according to two of the people.

A break with usual practice

Decisions on compounding have long rested with the FDA, which has an office dedicated to unsafe or poor-quality compounded drugs. Former FDA officials said it is extremely rare for HHS to take the lead in drafting compounding policy. Federal law technically gives HHS authority over essentially all drug regulation, which it delegates to the FDA.

Compounding safety became a bigger focus for the FDA after a deadly fungal meningitis outbreak in 2012, linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry.

Kennedy has called himself a "big fan" of peptides and recently described using BPC-157 for a muscle injury. He has said compounding pharmacies must be allowed to sell peptides because Americans are turning to "gray market" products imported from China and other countries.

In 2023 the FDA put more than a dozen peptides, including BPC-157 and TB-500, on its list of substances that should not be compounded because of risks of allergic reactions, kidney damage and tumor growth. At a meeting in July, FDA staffers repeated that more than half a dozen peptides up for reconsideration remained unproven for safety and effectiveness.

Source: The Guardian