Secretary of Health Robert F. Kennedy Jr.
However, in interviews with more than a dozen current and former FDA staff, layoffs will ultimately reduce the agent's workforce by 20% in different situations. Among them are experts who browse a range of laws to determine whether expensive drugs can be sold as low-cost generics; lab scientists tested contaminants or deadly bacteria from food and drugs; veterinary zoning experts investigated the spread of influenza in birds; and researchers monitoring TV advertising for false claims about prescription drugs.
In many areas of the FDA, no employee continues to process payroll, submits retirement or layoff paperwork, and helps overseas inspectors at risk of having an agent credit card. Even the institution's libraries, researchers and experts rely on now-cancelled medical journal subscriptions, but have been closed.
FDA's new commissioner, Dr. Marty Makary, made a debut at the agency's Maryland headquarters on Wednesday. He delivered a speech outlining a wide range of issues in the healthcare system, including the increase in chronic diseases. Employees don’t have a formal opportunity to ask questions.
About 3,500 FDA employees are expected to lose their jobs in the event of a decrease. A health and public service spokesperson did not answer questions.
When the Trump administration made its first round of cuts to the FDA in February, it dug out a team of scientists who carried out exquisite work to ensure the safety of surgical robots and equipment that inject insulin into children with diabetes. Former FDA officials quickly reversed some layoffs and cuts.
Dr. David Kessler, former agency commissioner and White House adviser, said in the pandemic response under President Biden that the latest round of layoffs has cut the agency’s important experience and knowledge.
“I think it's devastating, accidental, meaningless and confusing,” he said. “I think they need to be abolished.”
It is not yet certain whether the government will resume any lost work. In the interview, 15 current and former staff members, some of whom spoke on anonymously, fearing unemployment or retaliation, described the layoffs and their expected impact on the country’s food, drugs and medical supplies.
Weak food safety monitors
The agency has canceled scientists in several product safety labs, including a laboratory near San Francisco that tests food. In addition to the recent cancellation of a critical food safety committee and reducing funding for state-based food inspectors, the cuts are also included.
The San Francisco Laboratory conducted routine inspections of deadly bacteria on food to support inspections and investigations and have expertise in detecting heavy metals and toxic elements. It also analyzed food coloring and additives, which are clear priorities for the new government.
Another casualty in the Food Department involves almost all staff in the Office of Policy and International Engagement. It shares data with other countries to avoid food-borne disease outbreaks found overseas before the product arrives in the United States.
“If the outbreak in Canada is huge, will they notify the FDA and share that information?” asked Susan Mayne, a former FDA food official and adjunct professor of epidemiology at Yale University. “If so, who will they even inform? The communication channels have been broken.”
The International Food Office also works with developed countries to share inspection records of overseas food manufacturing plants – so more federal funds can investigate food processors in developing countries. It is not clear whether anyone will pick up work for the closed department.
Drug review funding hazards
The FDA is funded by industries it regulates, including medicines, medical devices and tobacco. The industry costs account for about half of the agency’s budget and are paid on terms negotiated between the agency and the industry. The agreement is monitored and approved by Congress.
Amid criticism from many, including Mr. Kennedy, these industries have an undue influence, and these agreements do not allow FDA employee reviewers to approve new drugs. However, employee reviewers must follow strict deadlines during the approval process.
These dramatic reductions could harm the total of hundreds of millions of dollars in user fees. The loss may result in a “trigger” in the law that will completely close the fees.
Few people can review lengthy drug approval applications, or authorize new cancer and rare disease drugs.
Although PHRMA, the pharmaceutical industry trade association, rejected an interview request, Alex Schriver, senior vice president of public affairs, said the substantial changes in the FDA “raise questions about the agency’s mission to bring new innovative drugs to patients.”
Complexing things, employees who manage industry expense plans and officials who involve terms surrounding expenses were fired.
Less drug safety inspections
Other labs that were eliminated include labs that study food packaging and how chemicals migrate to food in Chicago.
Almost all staff members were fired at the Drug Safety Laboratory in Detroit, which supports the work of the acting inspector. They tested samples of medication received by facility inspectors to check whether they were ready to open mass production or investigate potential problems. Staff also analyzed the products complained by consumers.
“The FDA’s laboratory scientists are very important to the structure of the institution,” NamandjéN, the principal deputy commissioner who left the institution in December. Dr. Bumpus said.
Staff monitoring drug safety and efficacy are also fired in a laboratory in San Juan, Puerto Rico, specializing in evaluating eye drops, nasal sprays and drugs
Potential delay is cheaper, universal medicine
Throughout the FDA, offices with the word “policy” in the title are designed to be phased out. While this work may seem trivial on paper, it is particularly important in the controversial world of generic drugs, accounting for 90% of the drugs used in the United States.
Staff at the General Drug Policy Office have carried out a hard work to screen existing laws, changing court rulings and scientific data to determine which drugs can be approved as generics, or in biologically active therapies as biosimilars. (Biosimilars are drugs considered to be interchangeable with brand drugs with biological activity.)
Such approvals could save consumers billions of dollars. The layoffs of the General Drug Policy team may delay these savings.
John Murphy III, chairman of the accessible drug association, who represents manufacturers of generic drugs, said in a statement that he supports efficiency efforts to get medication faster for patients, but “many of the reported cuts appear to be the opposite.”
Some work at the end of bird flu
Staff in the Office of the Director of Veterinary Medical Center were fired, which stopped some of the work in the response to bird flu. The office has studied how pasteurization kills bird flu in milk. It has also been investigating the spread of influenza from raw-flavored pet food to pets’ birds and is managing product recalls.
Scientists in the Veterinary Office have also adopted proposals to help the U.S. agricultural sector develop vaccines and treatments for animals designed to combat the virus and reduce egg prices.
Misleading drug ads lost watchdog
Mr. Kennedy criticized TV drug ads severely. But his new layoffs folded the department, which monitored them with false or misleading claims. The office received complaints from the public and issued a warning letter to the companies that filed a problematic claim. Although pharmaceutical companies were shocked by staff cuts, the change could be seen as a victory.
“Pharmaceutical companies must like the FDA’s collapse,” Adriane Fugh-Berman, a professor of pharmacology at Georgetown University Medical Center, said in an email. “The Trump administration is destroying institutions that are crucial to public health.”
