AP report: FDA scientists opposed the Trump administration's move to ease peptides access
A plan to give people in the United States 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 its development.
A proposal by the Trump administration to make unproven peptide drugs more accessible to Americans was met with strong opposition from the majority of Food and Drug Administration (FDA) scientists. These scientists, despite having limited input in the drafting process, raised significant safety concerns and warned that such a move could undermine the agency's mission of keeping unproven health products off the U.S. market.
The document outlining this policy, released by President Robert F. Kennedy Jr.'s Department of Health and Human Services (HHS), covers several injectable peptides popular in the wellness industry for muscle-building, injury healing, and energy-boosting purposes. The HHS effort, primarily led by HHS, faced substantial pushback from FDA drug staffers.
An HHS spokesperson did not immediately comment on the matter. The policy directs the FDA not to take action against specialty pharmacies selling six wellness peptides, including BPC-157, TB-500, and KPV. Currently, these chemicals would be considered illegal drugs due to lack of FDA review for safety and effectiveness. Kennedy, a known proponent of peptides, has previously used BPC-157 to treat a muscle injury.
The policy represents a deviation from HHS's original plans, with HHS officials initially seeking an FDA regulation that would add BPC-157 and other peptides to a list of safe drug substances for compounding pharmacies. FDA officials had major safety concerns and refused to support this approach. However, HHS decided to direct the FDA not to enforce its rules against pharmacies that compound these substances.
FDA staffers provided technical assistance in drafting the HHS plan, including safety measures such as requiring pharmacies to source ingredients from FDA-registered factories. Compounding pharmacies, which provide customized medications, have grown into a significant industry, but the FDA has been cautious due to safety concerns, notably following a deadly fungal meningitis outbreak linked to contaminated injections in 2012.
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- How FDA scientists opposed the Trump administration’s push for easier access to peptides fastcompany.com
- AP report: FDA scientists opposed the Trump administration's move to ease peptides access pbs.org
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