NYTimes: Kennedy Wants to Overhaul the F.D.A. H

NYTimes: Kennedy Wants to Overhaul the F.D.A. Here’s How Experts Would Change It.

1. Stop relying so much on industry funding.

Perhaps the biggest issue that experts and Mr. Kennedy agree on is that the agency receives too much money from the industries it regulates. Almost half of the F.D.A.’s budget, which is set by Congress, comes from “user fees” that pharmaceutical and medical device companies pay to the agency to review their products.

An F.D.A. official wrote in an email to The Times that “There is no connection between a fee paid to submit an application and the review outcome for that application.” But several experts raised concerns that user fees can make the F.D.A. beholden to those companies, and as a result, the agency may be susceptible to authorizing products without sufficient evidence that they are safe and effective.

“I’d like to see Congress fully fund the F.D.A. That would be the No. 1 step in my mind.”
Dr. Joel Perlmutter, professor of neurology at the Washington University School of Medicine
They pointed to the 2021 approval of the Alzheimer’s drug Aduhelm as an example of a concerning relationship between the agency and a drugmaker. An F.D.A. advisory committee recommended against the medication’s approval, but the agency authorized it anyway. Investigations later found that the F.D.A. had worked unusually closely with Biogen, the drug’s manufacturer, and had ignored internal concerns about the medication’s effectiveness.

“There’s an inherent conflict of interest,” said Dr. Joel Perlmutter, a professor of neurology at the Washington University School of Medicine, who also resigned from the advisory committee over Aduhelm’s approval. “The F.D.A. is dependent upon the applicants.”

Congress provides the other half of the F.D.A.’s budget, which will be $7.2 billion in 2025; in a perfect world, some of the experts said, it would cover all of the agency’s costs.

“I’d like to see Congress fully fund the F.D.A.,” Dr. Perlmutter said. “That would be the No. 1 step in my mind.”

But cutting user fees without replacing them with more Congressional funding would cripple the agency and potentially harm public safety, warned Dr. Peter Lurie, the president and executive director of the Center for Science in the Public Interest, an independent consumer advocacy organization. “User fees are a terrible idea,” he said — but “a dramatic cut in funding” would be worse.

2. Crack down on employees’ industry connections.

It’s not unusual for F.D.A. employees to be hired from drug or device companies or leave the agency to go work for them.

While bouncing between the F.D.A. and industry “is not inherently a bad thing, it does create a set of both perceived and real conflicts that I think are deeply problematic,” said Dr. Ashish Jha, dean of the Brown University School of Public Health.

But permanently “closing down the revolving door” between the agency and industry is “not practical,” said Dr. Lurie, who worked at the F.D.A. from 2009 to 2017. Instead, he and Dr. Jha called for a “cooling-off period” of a few years when people would not be able to work on the same product at their new employer that they did at the F.D.A. — or vice versa.

Advisory committee members can also have uncomfortably close ties with industry, several experts said. The F.D.A. official told The Times that advisory committee members “undergo thorough screening procedures consistent with U.S. federal conflict of interest laws and regulations.” But despite this, experts said, conflicts are not uncommon.

“Members of the advisory committee who have relationships with the applicant tend to vote more likely to approve than disapprove,” Dr. Perlmutter said. “And yet, in many review panels, there still are people who have conflicts.”

3. Close loopholes in the approval process.

Experts generally agreed that the F.D.A.’s approval process for new drugs and vaccines is rigorous. “In the vast majority of circumstances, it’s making good decisions because it has expert scientists and it has guidelines and rules that it operates under,” Dr. Kesselheim said.

But some experts worry that these high standards aren’t universally enforced across other divisions.P

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