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U.S. Food and Drug Administration

via:CnBeta     time:2020/8/23 22:31:29     readed:116

This week, the U.S. government targeted the U.S. Food and Drug Administration (FDA), first with a ban to deprive the health agency of the right to regulate laboratory testing methods; then, US President trump "stormed" on social media, accusing the agency of deliberately causing "dystocia" of vaccines. a series of actions have aroused heated debate. Experts worry that the trump government is using the new crown vaccine as a political "chip".


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Trump's "shelling" the food and Drug Administration

Aug .22, local time, Trump "shelled" the U.S. Food and Drug Administration (FDA) on social media, accusing the agency of "deliberately delaying vaccine trials" and delaying the development of new crown vaccines and drug therapies. The vaccine may not be available until after the November election. In this tweet, he also deliberately "named" the agency director Stephen Hahn.


Trump launched "shelling" the US Food and drug administration

Trump once again bombarded the agency on social media in response to the withdrawal of the FDA's authorization to use hydroxychloroquine and chloroquine to treat the new crown. Novel coronavirus pneumonia has been repeatedly claimed by Trump, but scientific research has denied his claim.

In addition, trump this week lashed out at the U.S. Food and Drug Administration for suspending the approval of plasma therapy as a new crown treatment, claiming that the move was politically motivated. However, public health experts, including fudge, the top infectious disease expert in the United States, believe that the data related to the treatment are still weak, and the FDA believes that the current evidence is not enough to support the effectiveness of plasma therapy.

Will the new ban "break the issue" or aggravate the crisis?

Just days before Trump's "shelling" the food and drug administration, the U.S. Department of health and human services (HHS) announced a new policy banning FDA from regulating laboratory tests, including the detection of new coronavirus, according to axios.com.

At present, most of the new crown virus detection equipment used in the United States is produced by specialized manufacturers and can only flow to the market after obtaining permission from the U.S. Food and Drug Administration. Some people support the new policy, who believe that the review process of the Food and Drug Administration is out of date, delaying the speed of testing, and the new policy can solve the problem of slow testing before.

But more public health experts are strongly opposed to the ban. They are concerned that some unreliable new coronavirus detection methods developed by independent laboratories will enter the market without examination, which will further affect the independence of the food and drug administration. Analysts pointed out that the ban will further weaken the power of U.S. health agencies.

Scott Gottlieb, a former head of the U.S. Food and Drug Administration, said the move would prevent the agency from providing critical advice to developers of testing equipment and taking the necessary measures to deal with poor testing methods in a timely manner. "There will be a significant flow of uncensored testing tools to the market, acting directly on consumers and processing results in laboratories outside the regulatory framework ." Gottlieb said ," the more people get the wrong results, the more likely it is to exacerbate the testing crisis that already exists in the United States ."

Worry: a vaccine tied to politics

Critics generally worry that the Trump administration will use the new crown vaccine as a political "chip" before the election at the expense of safety, putting pressure on the Food and Drug Administration to blindly promote vaccine development.

U.S. House president Nancy Pelosi accused trump of making "dangerous remarks," saying that the food and drug administration has the responsibility to review and approve drugs based on their safety and effectiveness, rather than the White House statement.

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Novel coronavirus pneumonia has no evidence that the food and drug administration is deliberately delaying the development of new crown vaccine or new crown pneumonia. In fact, Fudge has repeatedly said that the new crown vaccine will not be considered safe and effective until at least the end of this year. Senior U.S. Department of health and human services officials have also predicted that the new crown vaccine may not be developed until January next year.

Reuters reported that the scientific community is generally concerned that the trump administration may consider introducing a new vaccine with unproven safety and effectiveness before the election. In early August, trump told Fox News that a vaccine could be developed before election day.

This week, Peter Max, director of the Center for Biological Assessment and Research of the U.S. Food and Drug Administration, said he would resign if the Trump administration put the unproven safety and effectiveness of the new crown vaccine into use.

Max stressed that the food and drug administration can only rely on scientific guidance. "I can't sit back and watch unsafe or ineffective drugs get approved," marks said. "Touching my red line, I had to resign because it would show the American public that something was wrong."

According to CNN, novel coronavirus pneumonia Hahn, who has been in the column, said that although speed is critical to the new crown pneumonia pandemic, it is important to maintain strict scientific principles and protect vaccine testing volunteers.

John Maragano, chief executive of Alniram Pharmaceuticals, said politics must be far away from the new crown vaccine development evaluation, because it be related to public trust in drug and vaccine development.

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