RFK Jr. proposes FDA look the other way on unproven peptides, report says
摘要
据媒体报道，在卫生部长小罗伯特·F·肯尼迪领导下，FDA正推进放宽对未经验证肽类药物的获取限制。FDA科学家认为这些药物研究不足，安全性和有效性尚未确立，且可能造成伤害。FDA已向白宫提交“临时获取政策”供审查，知情人士称该政策将给予FDA对某些肽类药物的“执法自由裁量权”，允许其选择不执行现行限制，并向有意生产的 specialty pharmacies
Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving forward with plans to ease access to unproven peptide drugs that are popular among members of Kennedy's Make America Healthy Again movement—despite FDA staff scientists finding that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.
The FDA submitted an "Interim Access Policy" on peptides for review by the White House, according to a filing notice posted on an Office of Management and Budget website. The posting does not provide information on the proposed policy. But people familiar with the proposal told The Associated Press that it would give the FDA "enforcement discretion" on certain peptide drugs. This would allow the agency to choose not to enforce current restrictions on peptides and provide an assurance to specialty pharmacies eager to start making them that they will not be targeted by the agency.
The Department of Health and Human Services, which oversees the FDA, did not respond to a request for comment from Ars Technica.
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