FDA将药企代表从咨询小组中移除
FDA Removing Pharmaceutical Representatives From Advisory Panels

原始链接: https://www.zerohedge.com/medical/fda-removing-pharmaceutical-representatives-advisory-panels

美国食品药品监督管理局(FDA)局长马丁·马卡里博士正在撤销制药公司代表在其咨询委员会中的成员资格,以减少行业影响,并提升公众信任。马卡里表示,虽然行业员工仍然可以参加会议,但他们的正式成员身份造成了许多人担心的“密切关系”。 此前,FDA的32个咨询委员会(包括那些专注于疫苗和医疗器械的委员会)中的每一个都包括一名行业代表,尽管他们没有投票权,但仍然可以影响讨论。前任委员金·维特扎克质疑他们的存在。 FDA澄清说,这项指令不会阻止行业员工参加会议或表达他们的观点,并且可以为独特的专业知识做出例外。然而,马卡里强调需要进行独立的科学评估,并避免在医疗行业公众信任度低的情况下出现潜在的利益冲突。


原文

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The Food and Drug Administration (FDA) is removing pharmaceutical company representatives from advisory committees in a bid to limit industry influence.

Dr. Marty Makary, then the nominee to lead the Food and Drug Administration, testifies during a confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill in Washington on March 6, 2025. Madalina Vasiliu/The Epoch Times

Dr. Marty Makary, the FDA’s new commissioner, issued a directive that eliminates the role of pharmaceutical representative.

“Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans,” Makary said in a statement on April 17. “In fact, the FDA has a history of being influenced unduly by corporate interests.”

The FDA has 32 different advisory committees, including panels that advise the agency on vaccines, food, and medical devices. Members are primarily a mix of federal employees and experts who do not work for industries.

But each FDA committee has an industry representative and an alternate industry representative. The Vaccine and Related Biological Products Advisory Committee, for instance, had a Pfizer officer and a Dynavax officer listed on the roster for its most recent meeting.

The industry representatives do not vote on what advice to convey to the FDA, but “offer perspective of a pharmaceutical company,” Kim Witczak, who has served on several FDA advisory committees, told The Epoch Times in an email.

Sometimes they will say something that could influence or sway the discussion. I always wondered why they were on the committee,” she said.

The FDA did not release Makary’s directive but described it as limiting people employed at companies regulated by the FDA, such as pharmaceutical firms, from serving as members of FDA advisory committees.

“Today’s action will not preclude employees of regulated companies from attending or presenting their views at advisory committee meetings or serving as representative members of the committee when required by statute,” the agency stated. “Also, exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official strictly complies with the applicable ethics requirements.”

Makary said the directive was issued to make sure scientific evaluation of new products is independent.

“Public trust in the healthcare-industrial complex is at an all-time low. We need to restore impeccable integrity to the process and avoid potential conflicts of interest,” he said.

PhRMA, a trade group for the pharmaceutical industry, did not respond to a request for comment.

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