FDA Layoffs Could Raise Drug Costs and Erode Food Safety
He announced the Health Secretary Robert F. Kennedy Jr. Wide -ray cutback at Federal Health Agencies, including Food and Drug Administration, which would eliminate duplicative services and paper drug dealers.
But in the interviews with more than a dozen members of the current and ex -FDA staff, a different picture of the effects of the vast scope of the layoffs emerged which in the end would reduce the workforce of the 20 percent agency. Among these are experts who have sailed a labyrinth of laws to determine if an expensive drug can be sold as a generic at low cost; laboratory scientists who have tested food and drugs for contaminants or fatal bacteria; specialists of the veterinary division that investigate the transmission of avian influence; and researchers who have monitored television advertisements for false statements on prescription drugs.
In many areas of the FDA, they do not remain employees to process the paychecks, to present the pension or dismissal of waste and to help inspectors abroad at risk of maximizing the agency’s credit cards. The Agency’s library, in which researchers and experts entrusted the subscriptions to medical magazines that have been canceled, was closed.
The new Commissioner of the FDA, Dr. Marty Makary, showed up for a long -awaited appearance at the Agency’s Maryland headquarters Wednesday. He has held a speech that outlines great problems in the health system, including an increase in chronic diseases. Employees were not given a formal opportunity to ask questions.
About 3,500 FDA employees should lose their jobs under the reductions. A spokesman for health and human services did not answer questions.
When the Trump administration performed its first round of FDA cuts in February, this Enthralized teams Scientists who have done the delicate work of guaranteeing the safety of robots and surgical devices that instill insulin in children with diabetes. Some of the layoffs and cuts, described by former FDA officials as arbitrary, were quickly reversed.
Dr. David Kessler, a former commissioner for the agency and consultant of the White House on the pandemic response under President Biden, said that the last round of layoffs has marked decades of experience and crucial knowledge of the agency.
“I think it’s devastating, random, reckless and chaotic,” he said. “I think they must be canceled.”
It remains uncertain if any of the lost works will be restored by the Administration. In the interviews, 15 members of the current and ex staff, some of whom spoke on condition of anonymity, fearing the loss of jobs or retaliation, described the layoffs and their expected effects on food, drugs and medical supplies of the nation.
Weaker monitor for food safety
The agency has eliminated scientists in various product security workshops, including a laboratory near San Francisco who tested the food. These cuts come further to recent elimination of a key committee for food safety and reduced financing for state food inspectors.
The San Francisco laboratory has carried out routine controls for fatal bacteria on foods to support inspections and investigations and has had experience in detecting heavy metals and toxic elements. It Also analyzed Food and additives – a priority declared of the new administration.
Another victim of the food division involved almost all the staff of the office of policy and international involvement. He shared the data with other nations to get out of the outbreaks of foods of food origin that were detected abroad before the products could reach the United States.
“If Canada has a large outbreak, will it notify the FDA and share this information?” Susan Mayne asked, former FDA food official and epidemiology contract professor at Yale University. “And if so, who would warn? The communication channels have been broken.”
The International Food Office has also worked with the nations developed to share the inspection of food production systems abroad, so that more federal dollars could be investigated on food transformers in developing countries. It is not clear if someone will collect the work of closed divisions.
Financing of the revision of the drug Jeopardized
The FDA is strongly financed by the industries that regulates, including pharmaceutical products, medical devices and tobacco. The commissions of the sector, which represent about half of the agency’s budget, are paid pursuant to the terms negotiated between the agency and the industries. The agreements are monitored and approved by the congress.
Criticized by manyIncluding Mr. Kennedy, as a way for these industries to exercise an undue influence, the agreements do not oblige the FDA staff auditors to approve new drugs. But the staff auditors are required to respect the rigorous deadlines during the approval process.
Those steep reductions could compromise user commissions equal to hundreds of millions of dollars. The losses could lead to hitting a “trigger” in the law that would have closed the commissions completely.
This may not leave practically anyone to review long applications for approval of drugs or to authorize new drugs for cancer and rare diseases.
Although the commercial association for the pharmaceutical industry, Phma, refused a request for interview, Alex Schriver, senior vice -president for public affairs, said that the substantial changes in the FDA “raise questions about the ability of the agency to fulfill its mission to bring new innovative medicines to patients”.
By complicating the issues, the members of the invoicing and accounts staff who managed the program of the commissions of the sector and the officials who negotiated the terms around the commissions have been fired.
Less checks on drug safety
Other workshops that were decimated included one in Chicago in which scientists studied food packaging and how chemicals emigrated to food.
Almost all staff members were fired in drug safety Lab a Detroit This supported the work of agencies inspectors. They tested samples of drugs collected by the inspectors of the structures that controlled if a system was ready for opening for mass production or studying a potential problem. Personnel members also analyzed the products subject to consumer complaints.
“FDA laboratory scientists are very important for the agency’s fabric,” said dr. Namandjé N. Bumpus, main vice commissioner who left the agency in December.
The staff members who monitored the safety and effectiveness of the drugs were also fired in a laboratory in San Juan, in Puerto Rico, specialized in the evaluation of eye drops, nasal sprays and drugs administered with a patch on the skin
Potential delays in cheaper and generic drugs
Through the FDA, the offices with the term “political” in the title were targeted for the elimination. Although the work looks trivial on paper, it has been particularly important in the world highly contested with generic drugs, which represent about 90 percent of the drugs used in the United States.
Personnel members in the generic office of drug policy have carried out the scrupulous work of sifting through the existing law, the judicial judgments in constant evolution and scientific data to determine which drugs could be approved as generic or, in the case of biologically active therapies, biosimilar. (Biosimilars are drugs considered interchangeable with branded drugs and biologically active.)
These approvals are collectively saved to consumers billions of dollars. The layoffs of the generic drug policy team could delay these savings.
John Murphy III, the president of the Association for Accessible Medicines, which represents the producers of generic drugs, said in a declaration that supported efficiency efforts to obtain drugs for patients faster, but “many of the reported cuts seem to do the opposite”.
Some work on the influence of birds
The staff of the director of the director of the Center for Veterinary Medicine has been fired, bringing some work on the response to avian influence. The office had studied how pasteurization kills avian influenza in milk. He had also studied the transmission of the avian influence from food for pets to raw meat to pets and managed the calls of the products.
The scientists of the veterinary office were also helping the United States’s Department of Agriculture. Proposals for development Vaccines and treatments for poultry and animals aimed at fighting the virus and reducing egg prices.
Loss of guard dogs on the misleading advertising of drugs
Mr. Kennedy has abruptly Advertising of television drug advertising. But his new layoffs have folded the division that monitors them for false or misleading statements. The office received complaints from the public and issued warning letters to the companies that made problems. Although the pharmaceutical companies have opposed the cuts of the staff, this change could be seen as a victory.
“Pharmaceutical companies must love the deviation of the FDA,” said Adriane Fugh-Bemman, professor of Pharmacology at the Georgetown University Medical Center, on an e-mail. “The Trump administration is destroying a crucial agency for public health.”
