Health Secretary Robert F. Kennedy Jr. announced widespread cuts at federal health agencies, including the Food and Drug Administration, which eliminates overlapping services and paper pushers.
However, interviews with more than a dozen current and former FDA staff featured another photo of the widespread impact of layoffs that ultimately cut the agency's workforce by 20%. Among them are experts who have navigated the maze of law to determine whether expensive drugs can be sold as low-cost generics. Lab scientists who tested food and drugs for contaminants or fatal bacteria. Veterinary department experts investigating avian flu infections. Researchers who monitored advertisements that were aired for false claims about prescription drugs.
In many areas of the FDA, no employee will support overseas inspectors at risk of processing their pay, submitting retirement or layoff documents, or making the most of their agency's credit card. Even libraries of institutions that relied on subscriptions to medical journals where researchers and experts were now cancelled have been closed.
FDA's new commissioner, Dr. Marty McCurry, appeared on Wednesday in a much-anticipated appearance at Maryland headquarters. He gave a speech outlining a wide range of issues in the health care system, including an increase in chronic diseases. Employees were not given a formal opportunity to ask questions.
Approximately 3,500 FDA employees are expected to lose employment under the cuts. A spokesman for Health and Human Services did not answer the question.
When the Trump administration ran its first round with the FDA in February, it thwarted a team of scientists who did the nuanced job of ensuring the safety of surgical robots and devices injecting insulin into diabetic children. Some of the layoffs and cuts described as arbitrary volition by former FDA officials have quickly reversed.
Dr. David Kessler, a former agent committee member on the pandemic response under President Biden and White House adviser, said the latest round of layoffs has been deprived of decades of important experience and knowledge from the institution.
“I think it's devastating, coincidence, thoughtful and confused,” he said. “I think they need to be revoked.”
It remains uncertain whether any of the lost jobs will be restored by the regime. In the interview, 15 current and former staff members spoke on condition of anonymity, some of whom spoke and explained the expected layoffs and expected impacts on food, drugs and medical supplies, fearing unemployment or retaliation.
Weaker monitors for food safety
The agency has eliminated scientists from several product safety labs, including one near San Francisco, where they tested the food. These reductions come in addition to the recent elimination of major food safety boards and the reduction in funding for state-based food inspectors.
The San Francisco lab regularly checks deadly bacteria on foods to support testing and investigations, and has expertise in the detection of heavy metals and toxic elements. We also analyzed food coloring agents and additives. This shows the priorities of the new administration.
Another victim in the food sector involved almost all staff from the Department of Policy and International Engagement. It shared data with other countries to avoid the outbreak of foodborne diseases detected overseas before the product reached the US.
“If there's a big outbreak in Canada, will they notify the FDA and share that information?” asked Susan Maine, a former FDA food officer at Yale University and adjunct professor of epidemiology. “If so, who do they notify? The channels of communication are broken.”
The International Food Office has also worked with developed countries to share inspection records of food manufacturing plants overseas. As a result, more federal dollars have been spent investigating food processors in developing countries. It remains unclear whether someone will pick up work in the closed department.
Drug review funds are at risk
The FDA is heavily funded by regulated industries such as pharmaceuticals, medical devices and tobacco. Industry costs, which account for about half of the agency's budget, are paid based on terms negotiated between the agency and the industry. The contract will be monitored and approved by the Congress.
The deal does not require FDA staff reviewers to approve new drugs as a way for these industries to be overpowered, criticised by many, including Kennedy. However, staff reviewers must meet strict deadlines during the approval process.
These sudden cuts could put user fees worth hundreds of millions of dollars at risk. The loss could reach a “trigger” of the law, which would completely close the fees.
It may leave no one to review long drug approval applications or approve new drugs for cancer and rare diseases.
PhRMA, the pharmaceutical industry industry association, rejected the request for an interview, but senior vice president of public affairs, Alex Schriver, said the significant changes in the FDA “suppose questions about the agency's ability to fulfill its mission to bring new, innovative medicines to patients.”
Complicating the issue is the chargeable staff who managed the industry fee program and staff who negotiated terms regarding fees have been fired.
There are few drug safety checks
Chicago, where scientists studied food packaging and how chemicals moved into food, included other labs that were devastated.
Almost all of the staff were fired by Detroit's Drug Safety Lab to help with the agency's inspectors' work. They tested samples of medicine picked up by facility inspectors to see if the plants were open for mass production or ready to investigate potential issues. Staff also analyzed products that were subject to consumer complaints.
“FDA lab scientists are extremely important to the agency's fabric,” said Dr Namanji N. Bubbas, a key vice-commissioner who left the agency in December.
Staff who monitored the safety and efficacy of the drug were fired in a lab in San Juan, Puerto Rico, specialized in assessing drugs administered with eye drops, nose sprays, and patches to the skin.
Potential delays in cheap generic drugs
The entire FDA has the term “policy” in its title, and is subject to exclusion. This work seems trivial on paper, but was particularly important in a highly contested world of common drugs. This accounts for about 90% of the drugs used in the US.
Staff at the Generic Drug Policy Office have done a laborious task of sifting through existing laws and determining which drugs could be approved as biosimilars in the case of biologically active therapies. (Biosimilars are drugs that are considered interchangeable with biologically active branded drugs.)
Such approvals save consumers collectively billions of dollars. Layoffs for general drug policy teams can delay these savings.
John Murphy III, chairman of the Association of Accessible Drugs, which represents the manufacturer of generic drugs, in a statement, supported efficient efforts to make patients drugs faster, but said “many of the reported cuts look the opposite.”
There is also work on the end of the bird flu
Staff at the director's office at the Veterinary Medical Center were denied and stopped working to deal with the avian flu. The office was researching how pasteurization could kill milk bird flu. They also investigated the infection of bird flu from raw meat pet food to pets and managed product recalls.
Veterinary office scientists were also helping the U.S. Agriculture Agency organize proposals to develop vaccines and treatments for poultry and animals aimed at fighting the virus and lowering egg prices.
Loss of watchdogs on misleading drug ads
Kennedy has been sharply criticizing the aired drug ads. However, his new layoffs folded the department that monitored them for false or misleading claims. The office has issued a warning letter to companies making problematic claims after complaints from the public. Pharmaceutical companies are blocking staff cuts, but this change could be seen as a victory.
“Drug companies need to love the stigma of the FDA,” said Adrian Few Berman, a professor of pharmacology at Georgetown University Medical Center, in an email. “The Trump administration is destroying institutions that are essential to public health.”
