Kennedy accuses FDA of drug industry influence that barred alternative remedies

In a speech broadcast to the Food and Drug Administration's (FDA) Maryland campus Friday morning, Robert F Kennedy Jr introduced himself as the nation's health secretary with a meandering speech touching on everything from birds of prey to pollution in Lake Erie to the CIA.

Kennedy told the agency staff members, in the throes of losing 20 per cent of their workforce under his overhaul of the Health and Human Services Department, to boldly avoid the impulse to protect the corporations they regulate.

The layoffs, voluntary departures and cutbacks in funding have already decimated divisions that govern oversight of tobacco, the drug approval process, testing of cow's milk and cheese for avian flu, and food safety that monitors and protects consumers from food-borne illnesses.

In his remarks Friday, Kennedy suggested that the reason the agency did not approve "alternative medicines" was because of its subservience to well-heeled corporations. He has previously accused the FDA of suppressing raw milk, ivermectin and stem cell treatments. Agency veterans have argued that alternative remedies often fail to pass the standards for safety and efficacy.

He urged the staff to resist the temptation to serve a small group of wealthy companies at the cost of public health. "We want to break away from this so we can make our kids healthy," he said, according to a video and transcript of his speech that was shared with The New York Times.

At another point, he said, "the deep state is real," a pejorative reference to the sprawling federal bureaucracy that President Donald Trump blamed as an obstacle to achieving his goals in his first term.

Kennedy also called the FDA "a sock puppet" for the industries it is supposed to regulate, language he has used in the past.

Andrew Nixon, a spokesperson for the Health and Human Services Department, said in a statement that with his remarks on Friday, Kennedy was "telling the truth that many Americans already know."

Drugmakers have benefited from a series of efforts by the FDA to speed up certain drug approvals or encourage companies to develop drugs for serious diseases that lack treatments. Agency officials have said the programs are aimed at helping patients.

Kennedy said that "fast-track regulations" were well-intentioned. But over time, he said, "they've become instruments for the incumbents, the very, very powerful incumbents in the industry, to exclude dissidents and, you know, rare diseases and alternative medicines and those kind of things."

Kennedy also urged FDA employees to speak up if their superiors greenlight products inappropriately. "If your boss is making a mistake, if they're approving something that shouldn't be approved, we want to hear," he said.

Dr. Marty Makary, the new FDA commissioner, introduced Kennedy at Friday's meeting and endorsed his goals to shape a healthier food supply. He acknowledged that the cuts at the agency "have been hard on the ground" for some staff. He said the changes were "aimed at consolidating, being more efficient and creating more teamwork."

Kennedy and Makary were broadcast on a video aired at the agency's White Oak campus in suburban Maryland.

Kennedy reminisced in the speech about being a child visiting his father, Attorney General Robert F. Kennedy, at the Justice Department in Washington and watching peregrine falcons nesting in the cupola at the Old Post Office building. He also discussed his experiences working with people with intellectual disabilities, and the battles he waged as an environmental lawyer.

Kennedy also complained about rules governing the agency's food division that allow companies to certify that new ingredients are generally recognized as safe. The measure initially covered ingredients like salt or vinegar as acceptable in food with no review. In the years since, though, thousands of ingredients have been added to the food supply with no notice or testing by the agency.

Food companies are required to provide reviews of ingredients to on-site FDA inspectors, but such inspections can take place once every five years or less. Kennedy has called for an end to allowing food companies to self-certify that ingredients are safe.

"We literally do not test chemicals before they're added to our food," he said. "Everything is stamped by the industry as generally recognized as safe."

He went on to attribute the nation's rates of diabetes to the loophole, adding that sugar also plays a role.

The speech was reminiscent of a social media post from Kennedy in October, accusing the FDA of waging a "war on public health." He said the agency engaged in "aggressive suppression" of a range of unproven or unsafe products, including raw milk, chelating compounds, ivermectin and "anything else that advances human health and can't be patented by Pharma."

The post went on: "If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags."

The agency is still reeling from thousands of job cuts and voluntary departures in the weeks since Kennedy was appointed health secretary. The FDA employees who have left in recent weeks include staff members who examine drugs for byproducts that can cause cancer and others who work with international food safety staffs to try to stop contaminated products from entering the United States.

Cuts in some areas were so deep that former FDA officials have suggested that they could jeopardize billions of dollars in fees that the pharmaceutical industry pays to the agency to ensure the approval process for drugs is adequately staffed.

Drugmakers have been anxious about what Kennedy's leadership will mean for their interests. They are worried that cuts at the agency will slow down reviews of drugs, including the start of clinical trials, and will add delays to final approval.

A public letter signed by dozens of biotech investors and executives said the industry's leaders were "deeply concerned about the current state of the agency and its future."

"Some of us have already encountered regulatory difficulties that we believe are the consequences of the FDA's loss of experienced staff," the letter said.