FDA layoffs could increase the drug costs and undermine food safety
Health Secretary Robert F. Kennedy Jr. announced far -reaching cuts in federal health authorities, including the Food and Drug Administration, that would eliminate double services and paper slide.
In interviews with more than a dozen current and former FDA employees, however, another picture of the far-reaching effects of the layoffs, which would ultimately reduce the agency's workers by 20 percent. Among them are experts who navigated a labyrinth of laws to determine whether an expensive medication can be sold as an inexpensive generic. Laboratory scientists who tested food and drugs on contamination or fatal bacteria; Specialists of the veterinary department who examine the transmission of bird fluid; And researchers who are monitored by the incorrect allegations on the false claims on prescription drugs.
There are no employees in many areas of the FDA to process the salary statement, retire or discharge documents and help to improve oversee that have the risk of maximizing the agency's credit cards. Even the agency's library, in which researchers and experts were based on subscriptions for medical magazines that have now been canceled.
The new commissioner of the FDA, Dr. Marty Makary, appeared on Wednesday for a long-awaited appearance in the agency's headquarters. He gave a speech with comprehensive problems in the health system, including an increase in chronic diseases. The employees had no formal opportunity to ask questions.
It is expected that around 3,500 FDA employees will lose their work as part of the reduction. A spokesman for health and human services did not answer questions.
When the Trump administration carried out its first round of cuts in the FDA in February, she caught teams of scientists who did the delicate work of the security of surgical robots and devices that incorporate insulin in children with diabetes insulin. Some of the layoffs and cuts, which former FDA officers described as arbitrary, were quickly undone.
Dr. David Kessler, a former commissioner and advisor to the White House for the Pandemic reaction under President Biden, said that the latest round of layoffs has gotten decisive experience and knowledge of the agency for decades.
“I think it's devastating, arbitrary, thoughtless and chaotic,” he said. “I think they have to be lifted.”
It remains uncertain whether one of the lost jobs is restored by the administration. In interviews, 15 current and former employees, some of whom spoke about the condition of anonymity, because of loss or retaliation measures for jobs, to fear the layoffs and their expected effects on food, drugs and medical care for the country.
Weaker monitors for food safety
The agency removed scientists in several product security laboratories, including a laboratory near San Francisco, tested the food. These cuts come in addition to the recent elimination of an important committee for food safety and reduced the financing of state food inspectors.
The laboratory in San Francisco carried out routine reviews for fatal bacteria in relation to food to support inspections and studies, and had expertise in recognizing heavy metals and poisonous elements. It also analyzed food colors and additives – a specified priority of the new administration.
Another victim of the Food Division contributed almost all employees in the office for politics and international engagement. It has shared data with other nations to derive outbreaks from food transmitted by food that were recognized overseas before the products could reach the United States.
“If Canada has a big outbreak, then notify the FDA and share this information?” Asked Susan Mayne, a former top FDA food officer and extraordinary professor of epidemiology at Yale University. “And if so, who would you notify? The communication channels were broken.”
The International Food Office also worked with industrialized countries in order to be examined more federal dollars in developing countries overseas. It remains unclear whether someone will pick up the work of the closed departments.
Financing of the drug review endangered
The FDA is strongly financed by the regulating industries, including pharmaceuticals, medical devices and tobacco. The industry fees that make up about half of the agency's budget are paid as part of the conditions negotiated between the agency and the industries. The agreements are monitored and approved by the congress.
The agreements criticized the agreements by many, including Mr. Kennedy, as a way for these industries, and does not oblige the FDA employees to approved new drugs. However, the examiners of the employees have to comply with strict deadlines during the approval process.
These steep reductions could endanger user fees of hundreds of millions of dollars. The losses could lead to a “trigger” in the law that would complete the fees as a whole.
This could be practically not to leave anyone to check lengthy applications to admit pharmaceuticals or to approve new drugs for cancer and rare diseases.
Although the trade association for the drug industry, Phrma, rejected an interview application, said Alex Schriver, Senior Vice President for public affairs, the significant changes to the FDA, “to meet questions about the ability of the agency to bring their mission to new innovative medication”.
Complicated matters, the billing and awarding members who managed the industry fees and the officials who negotiated through the fees were dismissed.
Fewer reviews for drug security
Other decimated laboratories included a chicago in which scientists examined food packaging and how chemicals emigrated to food.
Almost all employees were released in a drug security laboratory in Detroit, which supported the work of the agency inspectors. They tested samples of medication that has been taken up by furnishing inspectors that check whether a system was ready to open for mass production – or to examine a potential problem. The employees also analyzed products that are subject to complaints from consumers.
“The FDA laboratory scholars are very important for the structure of the agency,” said Dr. Namandjé N. Bumpus, the deputy main commissioner who left the agency in December.
Employees who have monitored the security and effectiveness of the drugs
Possible delays in cheaper generics
In the entire FDA, offices were aimed at elimination with the term “guideline” in the title. Although work on paper appears trivial, it was particularly important in the high -controversial world of generics – which is about 90 percent of the medication used in the USA.
Employees of the Generika-drug policy office have carried out the careful work of the seven, through existing laws, constantly changing court holidays and scientific data to determine which drugs could be approved as generics or in the case of biologically active therapies as biosimilar. (Biosimilars are medication that is classified as interchangeable with biologically active branded medication.)
Such permits save consumers in billions of dollars. The layoffs of the generic drug politics team could delay these savings.
John Murphy III, the President of the Association for Accessible Medicines, which manufacturers represent generic, said in an explanation that he supported the efficiency efforts to bring patients faster, but “many of the reports reported seem to do the opposite”.
Some work on bird fluors
The director of the director of the director in the Center for Veterinary Medicine were released, which brought the reaction to bird flu to standstill. The office had examined how pasteurization kills bird flu in milk. It also examined the transmission of bird fluids from raw meat household food to pets and reminded recalls to the products.
Scientists in the veterinary office also helped the US farm department, suggestions for the development of vaccines and treatments for poultry and animals that aim to combat the virus and reduce egg prices.
Loss of watchdog in misleading drug advertising
Mr. Kennedy has sharply criticized drug ads transmitted on television. But his new layoffs folded the division, which she monitors for false or misleading claims. The office received complaints from the public and gave warning letters to companies that made problematic claims. Although the pharmaceutical companies have used the staff of the recruitment, this change could be regarded as a victory.
“Pharmaceutical companies have to love the FDA refinement,” said Adriane Fugh-Berman, professor of pharmacology at Georgetown University Medical Center. “The Trump government destroys an agency that is of crucial importance for public health.”
