Budget and endowment discounts at the Food and Drug Administration orchestrated by President Donald Trump could prevent new drugs “from being developed, approved or marketed in a timely time, or at all”, according to dozens of annual reports sent by pharmaceutical companies to the Securities and Exchange Commission.
“The Trump administration has promulgated several executive actions that could impose significant charges, or otherwise, the FDA capacity to engage in regulatory and routine monitoring activities,” explains a Xenon Pharmaceuticals file, a company based in Canada that is looking for treatment for epilepsy. “If these executive actions impose constraints on the capacity of the FDA to engage in surveillance and implementation activities in the normal course, our company can be negatively affected.”
In February, the so-called Elon Musk government’s efficiency department dismissed hundreds of FDA employees, causing general panic regarding the state of subsidy requests, active clinical trials and drug approvals. A little over a week later, that reinstated A handful of staff members who regulate American food supply and examine medical devices.
This decision did not do little to suppress the concerns of various pharmaceutical companies, which fear that any disruption of the slow bureaucracy can stop the FDA. Before new drugs can go on the market, the FDA must perform regular inspections and opinions, a process that can take years. Many recent dry deposits indicate that if the FDA stops this work, these drugs simply cannot be released.
The rezolute biopharmaceutical company, which draws up treatments for a rare and congenital form of low blood sugar, says that Doge’s mandate to “reduce expenses” in agencies like the FDA would slow their work, according to a dry file. The company adds: “Our company depends on the FDA and the capacity of the FDA to respond in a timely manner to our drug development activities.”
Some pharmaceutical companies have mentioned DOGE’s work at the National Institutes of Health, which provides dozens of billions of dollars for research and development of drugs to businesses and universities around the world.
Clover Health, a health care company that provides Medicare, said in a recent deposit that Doge creates “pressures and uncertainty” around the federal budget, including the debt ceiling, which, according to her, “can have a negative impact on the economic environment, reduces health and health care spending”.
Some deposits have also warned of the possibility that Trump will revise existing regulations on drugs, which would cost more time and money to respect. A recent Trump executive decree mandates a large deregulation in federal agencies, and the new secretary for health and social services Robert F. Kennedy Jr. expressed his agreement and expressed his agreement and propose its own budget cuts.
Doge has recently frozen $ 1.5 billion in the financing of medical research, then later Disgust Funds. The back and forth have left companies are not clear to find out if they can finally expect the US government to support its research. Ibio, a company based in San Diego which studies antibody treatments for obesity and cardio-metabolic disorders, said in a file that it is currently “clear” how Trump’s health care policy will affect research funding in its field.
