Robert F. Kennedy Jr. has set the Food and Drug Administration in his sights. He has claimed that the agency is in the pockets of the industries it regulates, allowing chemical additives to enter the food supply and greenlighting drugs while suppressing “cheap, generic and natural alternatives.” In an October post on X, he warned F.D.A. employees to “1. Preserve your records, and 2. Pack your bags.” After the election, he told NBC News that entire departments at the agency “have to go.”
Many medical and scientific experts say that if Mr. Kennedy were confirmed to lead the Department of Health and Human Services, which the F.D.A. falls under, his ideas could pose a danger to public health. An environmental lawyer with no medical training, Mr. Kennedy has several contentious and scientifically inaccurate opinions, particularly around vaccines and infectious diseases. (President-elect Donald Trump’s pick to lead the F.D.A., Dr. Martin Makary, a Johns Hopkins University surgeon, is seen as more mainstream but also has a contrarian streak.)
However, some experts do agree with Mr. Kennedy that the F.D.A. needs to change — except they say that the agency should have more resources and authority, not less.
“The F.D.A. isn’t a perfect institution,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, who resigned from an agency advisory committee to protest the controversial approval of an Alzheimer’s drug. But, he added, “it’s the most important public health agency that we have, and the role that it fills in our health care system is essential.”
The New York Times spoke with a dozen doctors, scientists and public health researchers about what, in an ideal world, they would like to see the F.D.A. do differently. Several have been vocal about the agency needing changes; some are former F.D.A. employees and advisers who worked under Democratic and Republican administrations. Here are the four ideas that came up most frequently.
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.
Medical Devices
Only a tiny fraction of medical devices go through the most rigorous approval process, which requires clinical studies to show safety and effectiveness. Roughly 99 percent are authorized via an alternate pathway, called 510(k), that just requires a new product be “substantially equivalent” to one already on the market.
The 510(k) process is intended for low-to-moderate-risk devices, such as wheelchairs and diagnostic tests, but experts worry that devices that need more stringent review are also being introduced to the market this way.
“The current 510(k) pathway is a joke,” said Dr. Rita Redberg, a professor of medicine at the University of California, San Francisco, who previously served on a medical device advisory panel. “The things that get approved are just shocking.”
She gave the example of a device used to prevent blood clots, which uses a string to tie off a heart chamber. It was cleared in 2006 through the 510(k) pathway for being equivalent to a skin suture. “I don’t know how you could say something you put inside someone’s heart to tie off a chamber is equivalent to a skin suture and not require any studies,” Dr. Redberg said. “But that’s what happened.”
In 2015, the F.D.A. issued a safety alert about the device after identifying several deaths and other serious complications, including hemorrhage, associated with its use.
In response to the experts’ criticisms, the F.D.A. official wrote that the agency expects “more evidence to support a marketing authorization decision” through the 510(k) program than in the past, including clinical data in some cases.
Food Additives
Another loophole several experts took issue with is the GRAS (Generally Recognized As Safe) designation.
The label, introduced in 1958, was intended to streamline the approval of new products that contained everyday ingredients already in the food supply, like vinegar and salt. But over time, it has become the go-to route for manufacturers to introduce virtually any new ingredient to the market. That includes hundreds of polysyllabic chemicals found in food additives, such as propylparaben and butylated hydroxyanisole.
“The F.D.A. is responsible for ensuring that dangerous and adulterated and mislabeled supplements are removed from the marketplace. What they have done in that area is remarkably little compared to the problem.”
Dr. Pieter Cohen, associate professor at Harvard Medical School
What’s more, companies are allowed to designate an ingredient as GRAS themselves and put their product onto the market without having to prove that it is safe or even inform the F.D.A.
“Either GRAS needs to be completely reformed, or we need to have an entirely new system,” said Dr. Sheela Sathyanarayana, a professor of pediatrics at the University of Washington who studies endocrine-disrupting chemicals.
Dr. Sathyanarayana also called for more efficient processes to review ingredients already on the market and remove them if they’re found to be unsafe.
The F.D.A. official wrote that “the food industry is responsible for ensuring the safety of ingredients,” but added that strengthening oversight of food chemical safety is an agency priority.
Supplements
Under the current laws, the F.D.A. does not approve dietary supplement ingredients or their labels. “Many dietary supplements can be legally brought to market without the F.D.A. even knowing,” the F.D.A. official acknowledged.
That lack of regulation has resulted in potentially dangerous products ending up on shelves, said Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies supplements. Recently, there have been reports of prenatal vitamins being contaminated with heavy metals, and of supplements like melatonin containing drastically different amounts than what’s listed on the bottle.
In these types of cases, the F.D.A. often sends warning letters to companies, but it rarely issues mandatory recalls. Dr. Cohen would like to see the agency use recalls more often, and much sooner. “The F.D.A. is responsible for ensuring that dangerous and adulterated and mislabeled supplements are removed from the marketplace,” Dr. Cohen said. “What they have done in that area is remarkably little compared to the problem.”
4. Break the F.D.A. into two agencies.
Some food safety experts called for a drastic change: separating the F.D.A. into two agencies, one focused on food and the other on drugs.
“The regulation of drugs is very different than the regulation of food, and if you try and apply the same model that you use for drugs to food, you can run into problems,” said Barbara Kowalcyk, the director of the Institute for Food Safety and Nutrition Security at George Washington University and a member of the F.D.A.’s Science Board.
An independent food agency could provide a larger budget for more frequent and rigorous inspections of manufacturing plants and produce farms, Dr. Kowalcyk said. With additional resources and greater authority, regulators could conceivably catch more problems before they reach the food supply and sicken people.
Better funding would also allow for more research into the connection between food and chronic diseases like heart disease and diabetes, said Jerold Mande, an adjunct professor of nutrition at the Harvard School of Public Health and the chief executive of Nourish Science, a nonprofit focused on nutrition policy and research.
“The regulation of drugs is very different than the regulation of food, and if you try and apply the same model that you use for drugs to food, you can run into problems.”
Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University
“They’re just never going to get funded” to do this research with the current structure, said Mr. Mande, who worked at the F.D.A. in the 1990s.
At a recent congressional hearing on the connection between food and chronic diseases, the F.D.A.’s outgoing commissioner, Dr. Robert Califf, agreed that the agency should do more research on food, and would if it had the necessary funding. “If we had a bigger budget,” he said, “we would have studied a lot more things.”
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