The budget and personnel cut at the food and pharmaceutical management agency by President Donald Trump can prevent newly developed, approved or commercialized drugs in a timely, or completely, annual report sent by pharmaceutical companies to the Securities Commission and Trading at the end of February.
The Trump administration has issued a number of executive actions that can impose significant burdens, or material delays, the ability to participate in FDA's regular regulation and monitoring activities. If these operating actions impose constraints on the ability to participate in the FDA's supervision and implementation activities in the usual course, our business may be negatively affected.
In February, the so -called Elon Musk Government's effectiveness fired hundreds of FDA employees, causing widespread panic about the situation of acute applications, positive clinical trials and drug approval. Just over a week later, it recover A small number of adjustment staff supply food and review US medical equipment.
This move has done very little to quell concerns from different pharmaceutical companies, who are worried that any interruption of the slow -moving bureaucracy may cause the FDA to delay. Before new drugs can be brought to the market, the FDA must conduct regular inspection and evaluation, a process that can take many years. Many recent SEC records said that if the FDA stops this job, these drugs are simply impossible to be released.
Rezolute Biological Pharmaceutical Company, developing treatments for a low, congenital blood sugar, said Doge's mission to reduce spending at agencies like FDA will slow down their work, according to a SEC record. The company added that our business depends on the FDA and the FDA's timely response ability with our drug development activities.
Some pharmaceutical companies mentioned Doge's work at the National Health Institute, which provides tens of billions of dollars for drug research and development to corporations and universities around the world.
Clover Health, a medicare providing health company, said that in a recent file, Doge is creating pressure and uncertainty around the federal budget, including debt ceiling, which announced it could negatively affect the economic environment, reduce spending on issues related to health care and health care.
Some records also warn Trump will overhaul the current drug regulations, which will spend more time and money to comply. A recent Trump Executive command The mission to abolish widespread regulations on federal agencies, and the new human and medical service secretary Robert F. Kennedy Jr. expressed the agreement and propose Cut your own budget.
Doge recently froze $ 1.5 billion sponsor medical research, then Open Funds. The passing companies were unclear whether they could eventually expect the US government to support their research. IBIO, a San Diego -based company studying antibodies on obesity and cardiovascular metabolism disorders, said that in a record that they are not clear Trump's health care policy will affect their research in their fields.