Ever since President Donald Trump nominated Robert F. Kennedy Jr. to the HHS secretary position, Kennedy has taken steps to publicly distance himself from unpopular and conspiratorial views he's shared in the past. But in a Friday speech to FDA employees, the HHS secretary laid bare his belief that the agency hasn't always acted in the best interest of Americans—going many steps further in his own colorful language.
The event at the FDA’s Maryland headquarters, meant to be a welcome from newly instated FDA commissioner Marty Makary, M.D., featured a 40-minute speech from Kennedy, Politico reports, citing transcripts and audio of the remarks. Confronting the agency staff directly, he called the FDA the “sock puppet” of the industries it regulates, according to the report.
“The deep state is real,” Kennedy said, as quoted by Politico, explaining that “every institution that’s created by human beings” is inevitably captured by powerful interests. He urged the staffers to be conscious of the “gravities of agency capture," because that force is “going to be pulling you every single day of your career," according to the report.
The “deep state” is a familiar talking point for Trump, who regularly posts about the concept on his social media platform Truth Social, the nonprofit watchdog Citizens for Responsibility and Ethics notes. To the president, the term refers to a group of powerful officials who wield “undue influence over government policies, regardless of the elected administration,” according to an article he posted last year from the Right Side Broadcasting Network.
The 'autism epidemic'
Kennedy’s FDA speech came after a Thursday pledge to find the cause of the nation’s “autism epidemic” by September through a “massive testing and research effort.” In his remarks at the FDA, he mentioned that he’d soon be releasing “new data” from the CDC that show that 1 in 31 children have now been diagnosed with autism, up from the agency’s most recent estimate of 1 in 36.
The September deadline he set for the task gave pause to autism advocacy groups, such as the Autistic Self Advocacy Network, which said the tight timeline “demonstrates his disregard for scientific studies, and his dangerous conviction that he has already found the answer.”
Kennedy, however, said in his FDA speech that information related to rising rates of chronic disease, allergies and other illnesses is “out there,” according to Politico. Those studies “aren’t done because they may offend the financial interests of powerful entities," he added.
The HHS secretary alluded to such interests of the pharmaceutical industry in an April 9 interview with CBS News, when he described pharmaceutical drugs as the “third biggest killer of Americans” and explained that his “overall objective is to realign the incentives for the industry, for hospitals, for the entire medical establishment with our public needs, which is to make America healthier again.”
Kennedy may be citing a March analysis by the American Society of Pharmacovigilance, which found that adverse drug events cause more than 250,000 fatalities annually. Adverse drug events are not on the CDC’s list of the ten leading causes for death in the U.S., which include heart disease, cancer and unintentional injuries.
An agency in tumult
Kennedy's FDA speech comes amid his large-scale rethinking of the nation's healthcare infrastructure, which includes cutting divisions, regional offices and tens of thousands of staffers to save $1.8 billion at the HHS annually and realign the organization “with its core mission and our new priorities in reversing the chronic disease epidemic,” the health secretary said in a March press release.
The initiative comes on top of 10,000 early retirements, or “fork in the road” exits, leaving the entire health department with around 62,000 staffers, down from 82,000 previously. Under Kennedy's leadership, the HHS will "do more—a lot more—at a lower cost to the taxpayer," he has said. However, the sweeping cuts have sparked concern from former FDA officials about the overall capacity of the agency to perform under these conditions.
The changes “decapitated” leadership at the FDA, former acting commissioner and former principal deputy commissioner of food and drug, Janet Woodcock, M.D., said during an April 7 session of the Biopharma Congress. Woodcock added that she believes the approach was “somewhat deliberate."
“I don't know what the administration's rationale for all these cuts were,” Woodcock said, noting that the claim that the cuts won’t impact drug reviews is a “naïve conception.”
In a recent open letter, more than 200 biotech leaders emphasized their concern that the FDA changes have already impacted the regulatory process. The industry innovators urged the government to “quickly preserve and restore” the core functions of the FDA.
“We worry that the institutional knowledge that makes the FDA the world’s leading regulatory body will be irretrievably lost due to the agency’s recent reduction in force and wave of retirements,” the biotech execs wrote.
Kennedy didn't make much mention of the FDA workforce cuts during his visit to the agency, according to Politico. Former director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., who recently resigned under the belief that he would be fired otherwise, described the health secretary’s relationship with FDA officials as “walled off” in a recent interview with the Associated Press.
FDA Commissioner Makary, however, emphasized that the agency wants to ensure that staffers "have all the resources you need to do your job well," according to Politico.