According to dozens of annual reports sent by pharmaceutical companies to the Securities and Exchange Commission in late February, budget and staff cuts by President Donald Trump at the Food and Drug Administration curated by Donald Trump may prevent new drugs from being “developed, approved or commercialized in a timely manner.”
“The Trump administration has enacted several executive actions that could put a significant burden on the FDA’s ability to engage in routine regulatory and oversight activities, or substantially delay,” said an application by Xenon Pharmaceuticals, a Canadian study that looked at treatments for epilepsy. “If these administrative actions impose restrictions on the FDA’s ability to monitor and implement activities in normal courses, our business may be negatively affected.”
In February, Elon Musk’s so-called government efficiency ministry ruled hundreds of FDA employees, causing widespread panic over the conditions of grant applications, proactive clinical trials and drug approvals. Just a week later, it resumed a handful of employees that regulated U.S. food supply and reviewed medical equipment.
The move has barely stopped concerns from various pharmaceutical companies, who fear that any disruption to the slow-moving bureaucracy could lead to the FDA’s cessation. The FDA must conduct regular inspections and reviews before a new drug can be marketed, a process that can take years. Many recent SEC documents say that if the FDA stops this work, these drugs simply cannot be released.
The SEC application says biopharmaceutical company Rezolute develops treatments for a rare form of congenital hypoglycemia, and he said that according to the SEC application, Doge’s task is to “reduce spending” at institutions such as the FDA. “Our business depends on the FDA and the FDA’s ability to respond to our drug development activities in a timely manner,” the company added.
Some pharmaceutical companies mentioned Doge’s work at the National Institutes of Health, which provides hundreds of billions of dollars in drug development and development to companies and universities around the world.
Clover Health, a health care company that provides Medicare, said in a recent filing that Doge created “pressure and uncertainty” on the federal budget, including debt ceilings, which it claims “could have a negative impact on the economic environment and reduce spending on health and health care-related matters.”
Some documents also warn that Trump will overhaul the existing drug regulations, which will take extra time and money to comply. A recent executive order from Trump calls for widespread deregulation in federal agencies, new Secretary of Health and Human Services Robert F. Kennedy Jr. agreed and proposed his own budget cuts.
Doge recently frozen $1.5 billion in funding for medical research and then handed out some funding. The companies back and forth are unclear whether they can ultimately expect the U.S. government to support their research. Ibio, a San Diego-based company that studies antibody treatments for obesity and cardiac metabolic diseases, said in a document that it is “not clear” how Trump’s health care policies will affect research grant funding in his field.
