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美国FDA提交政策变更以简化肽类药物配制US FDA takes step to change peptide compounding policy

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2020年8月29日,美国马里兰州白橡树,美国食品药品监督管理局(FDA)总部外的标识。路透社/安德鲁·凯利/资料照片Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

美国食品药品监督管理局(FDA)周四向白宫提交了一项新政策变更,该政策可能使药店更易于配制某些肽类药物。

The US FDA on Thursday submitted a new policy change that could allow pharmacies to more easily compound certain peptides to the White House for consideration.

远程医疗公司Hims & Hers Health(HIMS.N)曾表示,若法规允许,其计划提供肽类药物。

Telehealth company Hims & Hers Health (HIMS.N) had previously said it plans to offer peptides if regulations permit.

顾问曾建议FDA在7月份对正在审查的七种肽类药物中的六种放宽限制,其中包括广受欢迎的BPC-157。

Advisers had recommended the US Food and Drug Administration loosen restrictions on six of seven peptides under review in July, including the popular BPC-157.

肽类药物用于从止痛到肌肉恢复再到美容等多种用途,已被社交媒体网红和卫生及公众服务部长罗伯特·F·肯尼迪 Jr. 推广。它们是由短链氨基酸构成的药物,这些氨基酸也是人体制造蛋白质的基本构建块。

Peptides — used for everything from pain to muscle recovery to beauty — have been promoted by social media influencers and Health and Human Services Secretary Robert F. Kennedy Jr. They are drugs built from short chains of amino acids, the same building blocks the body uses to make proteins.

目前正在考虑的这些肽类药物尚未获FDA批准为安全或有效。配药药店被允许在特殊剂量和其他特定情况下混合已获批准药物的成分。

The ones under consideration have not been approved by the FDA as safe or effective. Compounding pharmacies are allowed to mix ingredients of approved drugs in specialized doses and other under circumstances.

根据管理与预算办公室网站上的备案文件,卫生及公众服务部和FDA已向白宫提交了一项关于“使用某些肽类药物进行配药的临时准入政策”以供审查。该备案文件未提供政策的任何细节。

The Department of Health and Human Services and the FDA submitted an "interim access policy for compounding using certain peptides" for White House review, according to a filing on the Office of Management and Budget's website. The filing does not provide any details of the policy.

美联社援引两位熟悉情况的人士称,该政策将允许配制一些流行的肽类药物,包括也被称为“金刚狼”的BPC-157。尽管该药物未获FDA批准,但其使用量正在激增。

The Associated Press, citing two people familiar with the matter, said that it would allow them to make some popular peptides, including BPC-157, which is also known as Wolverine. Despite not being approved by the FDA, its use is soaring.

Hims & Hers及卫生及公众服务部(该部门监管FDA)未立即回应路透社的置评请求。一位政府官员拒绝置评。

Hims & Hers and the Department of Health and Human Services, which oversees the FDA, did not immediately respond to Reuters' requests for comment. An administration official declined to comment.

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