During the Trump era, the FDA seeks to abandon expert reviews of new drugs

Arthur Allen

During the reign of President Donald Trump, the leaders of the FDA will move to abandoning a contract of contracts that are decades -old, which is to demand external experts to review drug requests, as critics say critics say will protect the agency’s decisions from public audit.

“I don’t think” I don’t think it is required, “said George Tidarish, head of the FDA,” said, “I don’t think” I don’t think it is required, “said George Tidarish, head of the FDA,” said, “I don’t think it is required,” said George Tidarish, head of the FDA.

In addition to being extravagant, Tidmarsh said, consulting meetings on specific drugs were “a huge amount of work for the company and to obtain food and drug management. We want to use this work and our time to focus on big questions.”

FDA consulting committees It was established in its current form under the 1972 law aimed at expanding and regulating the government’s use of experts in technical decisions. They were numbered periodically for advice, including reviewing evidence and voting on whether the FDA should approve drug, vaccines and medical devices, often when the FDA officials face a difficult decision.

The FDA actions (FDA) is compatible with the committee’s votes. The departure can prove the controversy and general debate, as was the case with the Split 2021 resolution on whether Biogen Aduhelm will be approved to treat Alzheimer’s disease.

Food and Drug Administration Agree on the medicine Despite the “no” vote from her advisory committee, whose members felt that medicine did little to treat the disease. The struggle over Aduhelm struggle to reconcile the pressure from the desperate and desperate patients with its careful evaluation of the risks and benefits of drugs.

Timarsh said that committees are still consulting on public issues such as how to organize different groups of medicines. But meetings on specific drugs, where experts were conducting through piles of studies and hours of certificates from the FDA officials and officials of the company, were mainly useful, because they allowed the public to see how the Food and Drug Administration works.

The Food and Drug Administration (FDA) has started this month to publish the “full response letters” that it sends to companies when it refuses to agree to its products. Timarsh said that the launch of the messages, which were previously required to deposit applications under the Federal Freedom Law, enhance a level of transparency closer to consulting meetings.

He told KFF Health News in a short interview after he appeared at the Health Care Products Conference: “The meetings of the Advisory Committee on Individual Drugs” are excessive when you have complete review messages.

FDA officials and academics who study the agency do not agree. They said that the meetings help food and drug managers to make decisions and increase the public’s understanding of drug regulation, and to abandon them in meaning.

“It is difficult to follow.” “It is very useful for people within the FDA to find out what other experts think before making their final decisions. It is important to do this in a way that enables the public to understand the views.”

“Experts may ask questions about the company or the FDA that neither of them thought alone,” said Holly Fernandez Lynch, Associate Professor of Biology and Law Ethics at the University of Pennsylvania. “The public has some other opportunities to comment on the decisions of the FDA.”

The FDA spokesperson (FDA) and the Department of Health Services and Humanitarian Services did not respond to repeated requests to access Tidmarsh comments.

Calif sometimes did not agree to the consulting committees as a proxy for the agency, and once put forward the idea that it may be better if they traded but they did not vote on the products. However, while “perhaps someone could reach a better system, I always thought it was a great system.”

FDA (FDA) does not require to ask external experts to review drugs and usually do not. It mainly calls them for important new types of medications or when the decision is especially difficult due to the high demand for a product that may have limited value, as Aduhelm is a classic example.

Sarah Ryan, a spokeswoman for pharmaceutical research and manufacturers in America, said the consulting committees are an “important resource” for the FDA. “They can play an important part of the strict human drug review process that we have in the United States.”

The committees are often required by the auxiliary committees to settle disputes within the Food and Drug Administration on how to move forward in an organizational decision.

She and other researchers and former FDA officials (FDA) praised the decision to publish full response messages.

Peter Lori, a former food department commissioner who heads the Science Center in the public interest, said the messages do not avoid the need for the committee’s meetings.

Lori said: “A full response letter told the public that the company has been rejected and why.” “Here’s what we think about doing and we love your inputs before we decide,” says a meeting of an advisory committee for external experts and the public. Clearly, this is not equivalent. “

The changes described by Tidmarsh are already playing on the floor. The Food and Drug Administration (FDA) has held only seven meetings of a consulting committee since Trump re -inserted the White House, compared to 22 on the same time frame last year. Officials say they will now issue full response messages when sending it, and published a group of 89 earlier in September.

Macari has somewhat Replace the consulting committeesThose whose organs were traditionally examined for experience and biases and any Required to trade in public placesWith paintings of chosen scholars who support his views on topics such as Hormone therapy alternative and Antidepressants.

Diana Zuckerman attended a critical of the pharmaceutical industry, July a hormone alternative panel Which was considered a list of warning from the Food and Drug Administration Fund (FDA) the risk of the treatment list. It was Makari He wanted to remove the warning Fill the painting with similar experts in thinking.

She said that the event was called in a hurry without an opportunity for the audience to review or comment on discussion materials.

“All this was transparent that they do not want to hear from anyone who does not agree with them,” said Zuckerman, who leads the National Health Research Center.

Before becoming a commissioner, Makari pushed more meetings of the Consulting Committee. In early 2022, the FDA decision to agree to the reinforcements of children between the ages of 12 and 15 without consulting the Consultative Committee for Related Biological Products. Mkari deployment On the social platform x at the time, “It is a slap in the face of science for @us_fda to circumvent the standards of the expert advisory council.”

But it seems that Timarish is different.

Instead of asking the Consulting Committee to vote in favor or against muscle atrophy, he said that the FDA will serve better by a committee that studies the best way to evaluate these drugs, such as results, or end points, to measure them. “Is this final point correct for muscle Duchenne atrophy? This is an important question that exceeds many different companies,” he told KFF Health News.

Venay Brasad, in charge of the Food and Drug Administration (FDA), canceled the plan of the planned advisory committee in July to discuss the property of Duchene presented by the Capricor Therapeutics. The Food and Drug Administration later published its rejection, or “full response letter”, to Capricor, which then published a letter of response to the Food and Drug Administration. Brasad was later pushed and re -employed with fewer powers.

Ramashandran said that the consultative committee meeting could have been working through the dangers of drugs and its benefits in a quieter, public and less politicized atmosphere.

FDA usually agree with the votes of consulting committees dozens. A 2023 studies I found that the FDA agreed with 97 % of the “Yes” votes and 67 % of the “no” votes.

“The comments of Timars” are a complete surprise. ” The Food and Drug Administration (FDA) has postponed many meetings this year, but “everyone thought it was temporary, with the transition and all shootings.”

She said: “Another theory is that this decision is strategic,” in terms of unifying power in the agencies so that it is not responsible for external experts or the public. “

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