In a speech aired on the Food and Drug Administration’s Maryland campus Friday morning, Robert F. Kennedy Jr. introduced himself as the country’s health secretary in a mean speech that touched on everything from the raptors of Lake Erie to the CIA.
Kennedy told agency staff in an effort to boldly avoid the impulse to protect the companies they regulate amid the pain of losing 20% of the workforce under an overhaul of the health and human services sector.
Layoffs, voluntary departures and cuts in funding have already stopped the sectors controlling tobacco surveillance, drug approval processes, testing bird milk and bird flu cheeses, and food safety, which monitors and protects consumers from foodborne diseases.
In his remarks Friday, Kennedy suggested that the agency did not approve “alternative drugs” because of its subordination to wealthy businesses. Agent veterans argue that alternative products often fail to pass safety and efficacy standards.
He previously accused the FDA of suppressing raw milk, ivermectin and stem cell therapy.
He urged staff to resist the temptation to serve small groups of wealthy businesses at the expense of public health.
“We want to break away from it so that we can make our children healthy,” he said, according to a transcript of the speech shared with the New York Times. At another point, he said, “The deep nation is the real thing.” This is a light-journal reference to the vast federal bureaucracy that President Trump accused of as an obstacle to achieving his goals in his first term.
Department of Health and Human Services spokesman Andrew Nixon did not immediately respond to requests for comment on Kennedy’s remarks.
Kennedy also calls the FDA “sock dolls.” He used it in the past. Dynamics rewards “a very powerful incumbent in the industry,” he said at another time.
Drugmakers have benefited from a series of efforts by the FDA to speed up specific drug approvals and encourage businesses to develop drugs for serious illnesses that lack treatment. An FDA official said the program is intended to help patients.
The FDA has faced criticism over the past few years for several well-known drug approvals. For example, when granting approval for Alzheimer’s and Duchenne muscular dystrophy products, the top officials rejected the agency’s scientist or advisor.
Kennedy urged FDA employees to speak up if their boss greenlights products with insufficient evidence. “If your boss is making a mistake, if they approve something that shouldn’t be approved, we want to hear,” he said.
New FDA committee member Dr. Marty McCurry introduced Kennedy at a meeting Friday, supporting the goal of shaping healthier food supplies. He admitted that for some staff, cutting at the agency is “struggling with the ground.” He said the change was “to be integrated, more efficient and create more teamwork.”
Kennedy and Dr. McCurry were broadcast on video that aired on the agency White Oak campus outside Maryland.
Kennedy visited her father, Attorney General Robert F. Kennedy, at Washington’s Department of Justice, and recalls her child watching the Peregrine Falcons nest in the cupola of an old post office building. He also discussed his experiences at the Special Olympics, where he played the role of “Hugger” and coaching, playing the battles he played as an environmental lawyer.
Kennedy also complained about the rules governing the agency’s food department, which allow businesses to recognize that they can generally be recognized as being safe. This scale initially covered ingredients such as salt and vinegar to be acceptable in food without review. However, since then, thousands of ingredients have been added to the food supply without notice or testing by agents.
Food companies must provide a review of the materials to the FDA inspector on the premises, but such inspections can be performed once every five years. Kennedy is calling for an end to allow food companies to self-certify that the ingredients are safe.
“We literally don’t test chemicals before they’re added to food,” he said, according to the transcript. “Everything is engraved by the industry, as is generally perceived as safe.”
He went on to attribute the country’s diabetes rate to a loophole, adding that sugar also plays a role.
The speech was reminiscent of a social media message Kennedy posted in October, accusing the FDA of “a war with public health.” He said he is engaged in a “active suppression” of a series of unproven or unsafe products, including raw milk, chelate compounds, ivermectin, and “others that advance human health and cannot be patented by pharma.”
Here’s the post: “If you’re working for the FDA and are part of this corrupt system, you have two messages.
The agency is still shaking from thousands of job openings and voluntary deviations in the weeks since Kennedy was appointed health secretary. FDA employees who left in recent weeks include staff looking for drugs for byproducts that could cause cancer, and others working with international food safety staff to stop contaminated products from entering the United States.
The cuts in some regions are so deep that former FDA officials have suggested that the pharmaceutical industry could endanger billions of dollars to pay agents to ensure that the drug approval process is properly staffed.
Drugmakers are worried about what Kennedy’s leadership means for their benefit. They are worried that agency cuts will slow down drug reviews, including starting clinical trials, and will add a delay to final approval.
Public letter Dozens of biotech investors and executives have signed the signing, and industry leaders say they are “deeply concerned about the current state of the agency and its future.”
“Some of us have already encountered regulatory challenges that the FDA considers to be the result of the loss of experienced staff,” the letter states.
Source: www.nytimes.com
