美国卫生部长小罗伯特·F·肯尼迪周二表示,特朗普政府旨在通过建立受监管的市场来扩大肽类药物的获取渠道,这些药物由社交媒体影响者和卫生部长本人推广。
Kennedy says Trump administration aims for regulated market for peptides WASHINGTON, Oct 20 - US Health Secretary Robert F. Kennedy Jr. said on Tuesday the Trump administration aims to expand access to peptides by creating a regulated marketplace for the drugs promoted by social media influencers and by the health secretary.
这些药物在灰色市场吸引了消费者,社交媒体宣称其有多种未经证实的用途,且缺乏人体研究的安全性和有效性证据。
They have attracted consumers in a gray market, bolstered by social media claims for a host of unproven uses, and with scant safety and efficacy evidence from human studies.
肯尼迪在福克斯新闻节目《威尔·凯恩秀》的采访中说:“美国人反正都会购买这些产品。我们的目标是确保有一个受监管的市场,这样他们买到的就是标称的产品,是安全的,工厂也会接受检查。”肯尼迪的言论是针对美国食品药品监督管理局(FDA)周四提交白宫审查的一项拟议政策变更作出的回应。该提案可能使药房更容易配制某些肽类药物。
"Americans are going to be buying these anyway. Our objective was to make sure that there is a regulated marketplace, so that what they're getting is what they claim to be, that is safe, that the factories are inspected," Kennedy said in an interview on Fox News' "The Will Cain Show." Kennedy's comments were in response to a question about a proposed policy change that the FDA submitted on Thursday to the White House for review. The proposal could make it easier for pharmacies to compound certain peptides.
FDA的外部顾问曾于7月建议该机构放宽对正在审查的七种肽类药物中六种的限制,包括广受欢迎的BPC-157,这与FDA工作人员的指导意见相悖。
Outside advisers to the FDA had recommended in July that the agency loosen restrictions on six of seven peptides under review, including the popular BPC-157, against the guidance of Food and Drug Administration staff.
尽管缺乏科学证据证明其疗效,肽类药物被用于从止痛、肌肉生长、伤病恢复到美容等各种用途,并在社交媒体上以及肯尼迪本人推广下广为传播。肽类由短链氨基酸组成,这些是人体制造蛋白质的相同构建模块。
Peptides, which are being used for everything from pain to muscle growth and injury recovery and as a beauty aid despite the lack of scientific evidence of their efficacy, have been promoted widely on social media, and by Kennedy himself. They are built from short chains of amino acids, the same building blocks the body uses to make proteins.
正在考虑的这些肽类药物尚未获得FDA批准为安全有效。配制药房被允许在特定剂量和其他情况下(如药品短缺)混合已获批药物的成分。
The ones under consideration have not been approved by the FDA as safe or effective. Compounding pharmacies are allowed to mix ingredients of approved medicines in specialized doses and under other circumstances, such as drug shortages.