Budget and staff cuts at the food and drug administration orchestrated by President Donald Trump can prevent new medicines from being “developed, approved or commercialized, or at all,” according to dozens of annual reports sent by pharmaceutical companies to the Securities and Exchange Commission.
“The Trump administration has performed several executive actions that have the FDA’s ability to participate in routine regulatory and supervisory activities, a significant burden on the FDA’s ability to move on, or otherwise delay,” says one filing of Xenon Pharmaceuticals, a company in Canada. “If these executive actions impose restrictions on the FDA’s ability to oversee supervision and implementation activities in the normal course, our business can be negatively affected.”
In February, Elon Musk’s so-called government efficiency fired hundreds of FDA employees, which caused widespread panic over the status of awards applications, active clinical trials and drug approvals. Just a week later, it has a handful of staff members who regulate the US food supply and regulate medical devices.
The move has done little to end the concerns of different pharmaceutical companies, which are concerned that any disruption of the slow moving bureaucracy could stop the FDA. Before new medicine can go to the market, the FDA must do regular inspections and reviews, a process that can last years. Many recent SEC files say if the FDA stops this job, this medicine simply cannot be released.
Biopharmaceutical company Rezolute, which develops treatments for a rare, congenital form of low blood sugar, says that Doge’s mandate to reduce ‘expenses’ at agencies such as the FDA would delay their work, according to a SEC filing. The company adds: “Our business depends on the FDA and the FDA’s ability to respond to our medicine development activities in time.”
Some pharmaceutical businesses mention Doge’s work at the National Institutes of Health, which offers dozens of billions for drug research and development to corporations and universities around the world.
Clover Health, a healthcare business that provides Medicare, said in a recent filing that Doge ‘is creating pressure on and uncertainty’ around the federal budget, including the debt ceiling, which, according to the economic environment, could affect a negative impact on the economic environment, the expenses of health and health-related matters.
Some reports have also warned about the possibility that Trump will review existing drug regulations, which will cost extra time and money to comply. A recent Trump executive order requires broad deregulation on federal agencies, and the new secretary of health and human services, Robert F. Kennedy Jr., expressed an agreement and proposed his own budget cuts.
Doge recently frozen $ 1.5 billion in medical research financing, and later exposed some of the funds. The back and forth have left companies unclear whether they can eventually expect the US government to support their research. Ibio, a company in San Diego who studies antibody treatments for obesity and cardio-metabolic disorders, said in a filing that it is currently “unclear” how Trump’s healthcare policy will affect the granting of financing for research in his field.