Trump official takes steps to expand access to 6 unapproved injections

Trump official takes steps to expand access to 6 unapproved injections

National PoliticsHealth and Human Services Secretary Robert F. Kennedy Jr. speaks as President Donald Trump listens during a meeting to sign an executive order about vaccines, Monday, Aug. 10, 2026, in the Oval Office of the White House in Washington. (AP Photo/Jacquelyn Martin)AP Photo/Jacquelyn MartinHealth and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday he is moving forward to allow patient access to six peptide injections that haven’t been approved by the Food and Drug Administration.Kennedy said he would do so by “enforcement discretion,” which allows the FDA to selectively choose to not enforce some of its own regulations, temporarily bypassing the review process that determines safety and effectiveness.Six peptides — BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 — are included in the draft policy, which directs specialty pharmacies and physicians to compound them while regulators consider whether ‌to formally permit their use.“Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed. Although compounded drugs can serve an important medical need for certain patients, they also may pose risks to patients,” the document reads.But it goes on to say that “based on the Pharmacy Compounding Advisory Committee (PCAC) meeting and data regarding utilization of peptides, HHS believes that there is significant interest in the use of these peptides in compounding.” Kennedy has said publicly that he supports access to the peptides, calling himself a “big fan” of the treatments. Some of the peptides have been promoted by online influencers, who claim they can speed up the healing process, lead to weight loss and cure chronic pain.“Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety,” the document says.FDA officials have warned that the agency’s drug staffers have major safety concerns. According to the Associated Press, the new document has since faced pushback internally by some who have warned that it may signal the agency moving away from its mission of keeping unapproved health products off the U.S. market.Rachel Cohen covers national politics as a reporter for Advance Local, focusing on President Donald Trump's second term and Congress. She previously worked as a trending political reporter for NJ.com. Her work...

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