Trump FDA cuts are putting drug development at risk- BC

Trump FDA cuts are putting drug development at risk– BC

Budget and personnel cuts in food and medicines administration orchestrated by President Donald Trump could prevent new medications from being developed, approved or marketed in a timely manner, or at all, “according to dozens of annual reports sent by pharmaceutical companies to the stock exchange and values ​​commission at the end of February.

“The Trump administration has promulgated several executive actions that could impose significant loads or materially delayed, the ability of the FDA to participate in regulatory and routine supervision activities,” says a presentation by Xenon Pharmaceuticals, a company based in Canada that investigates the treatments for epilepsy. “If these executive actions impose restrictions on the ability of the FDA to participate in supervision and implementation activities in the normal course, our business can be negatively affected.”

In February, the so -called Elon Musk government efficiency department fired hundreds of FDA employees, causing generalized panic about the status of subsidies requests, active clinical trials and medication approvals. Just over a week later, reinstalled A handful of employees regulating American food supply and reviewing medical devices.

The measure did little to quell the concerns of several pharmaceutical companies, who are concerned that any interruption of the slow motion bureaucracy can make the FDA stop. Before the new medications can go to the market, the FDA has to perform regular inspections and reviews, a process that can take years. Many recent present presentations say that if the FDA stops this work, these drugs simply cannot be released.

The Biopharmaceutical company Rezolute, which develops treatments for a rare and congenital form of low blood sugar level, says that Doge’s mandate to reduce expenses “in agencies such as the FDA would reduce its work, according to a presentation in the SEC. The company adds: “Our business depends on the FDA and the ability of the FDA to respond in a timely manner to our medication development activities.”

Some pharmaceutical companies mentioned Doge’s work in the National Health Institutes, which provides tens of billions of dollars for drug research and development to corporations and universities around the world.

Clover Health, a medical care company that provides Medicare, said in a recent presentation that Dege is creating “pressures and uncertainty” around the federal budget, including debt roof, which states that “it can negatively affect the economic environment, reduce spending on matters related to health and medical care.”

Some presentations also warned about the possibility of Trump reviewing existing drug regulations, which would cost additional time and money to meet. A recent Trump Executive order It requires broad deregulation between federal agencies, and the new Secretary of Health and Human Services Robert F. Kennedy Jr. has expressed agreement and proposed Your own budget cuts.

Doge recently frozen $ 1.5 billion In funds for medical research, then later You did not conceal some of The funds. The round trip companies of the companies are not clear about whether they can finally expect the United States government to support their investigation. Ibio, a company based in San Diego that studies the antibody treatments for obesity and cardio-methabolic disorders, said in a presentation that is currently “unclear” how Trump’s medical care policy will affect the financing of subsidies for research in his field.

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