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Emergency hydroxychloroquine

FDA ends emergency use of hydroxychloroquine for coronavirus – POLITICO

A bottle of hydroxychloroquine tablets. | David J. Phillip, File/AP Photo

The Food and Drug Administration on Monday withdrew emergency use authorizations for two coronavirus treatments that President Donald Trump promoted despite concerns about their safety and effectiveness.

The agency revoked the authorizations for hydroxychloroquine and chloroquine after a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority.

Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence. More recent randomized controlled trials have found the drugs do not benefit coronavirus patients, and doctors have reported that hydroxychloroquine can cause heart problems.

Because hydroxychloroquine is approved for other uses — treating lupus and arthritis — doctors could still use it “off label” to treat coronavirus patients, and clinical trials examining their use against Covid-19 can continue. The FDA noted that the version of chloroquine that had been authorized for emergency use is not approved in the U.S. so all use of that drug, donated by Bayer, will now end.

The administration’s focus on the malaria medicines in the early months of the pandemic deepened a divide between the White House and its health agencies. Several administration officials told POLITICO they felt the drugs got outsized attention while FDA scrambled for solutions in March. Other current and former Health and Human Services officials later said that the emergency authorities and White House demands cast a shadow on FDA as it struggled to remain independent.

Rick Bright, the former BARDA director whom Disbrow replaced, has accused health officials of removing him from his role overseeing millions of dollars to develop treatments and vaccines because he raised health concerns about hydroxychloroquine and resisted its widespread use.

Drugmakers donated millions of the pill to the government’s strategic national stockpile after Bright wrote to the FDA requesting for emergency use, a move he now says he was pressured to make.

In April, roughly a month after the FDA authorized emergency use of the drugs, the agency warned against using hydroxychloroquine outside of hospitals and clinical trials because of potentially fatal cardiac side effects. Trump toned down on mentions of the pills during his White House briefings around the same time, but in May told reporters he was taking a course of hydroxychloroquine after a White House aide was diagnosed with the coronavirus.

This month two randomized controlled trials, considered the gold standard for determining whether a drug is effective, concluded that the drug does not prevent coronavirus infection and did not help hospitalized patients.

Another study based on tens of thousands of patient records linked hydroxychloroquine to a higher risk of heart problems, but it was withdrawn after questions arose about the quality of the data it used. Doctors have anecdotally reported that the pills, especially when paired with antibiotic azithromycin, can cause heart problems like arrhythmia.

Though drugmakers have donated millions of pills to federal and state governments, it is not clear how many have even been used. Florida, for instance, is sitting on more than 980,000 unused doses from an April donation after just six hospitals put in requests for the drug.

Senate Democrats grilled FDA officials on the emergency use authorization during a Finance Committee hearing this month. Sen. Tammy Baldwin (D-Wisc.) later wrote to Commissioner Stephen Hahn demanding answers on the decision and reasons why it had not been revoked.

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Emergency Grants

FDA Grants Emergency Use Authorization For 1st Coronavirus Antigen Test – NPR

The FDA has granted its first emergency authorization for antigen testing. Cheaper and easier to administer than genetic diagnostic testing for the virus, the agency says it could potentially scale to daily testing of millions.

Seth Wenig/AP


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Seth Wenig/AP

The FDA has granted its first emergency authorization for antigen testing. Cheaper and easier to administer than genetic diagnostic testing for the virus, the agency says it could potentially scale to daily testing of millions.

Seth Wenig/AP

The Food and Drug Administration announced Saturday that it has granted its first emergency authorization to a new type of test that can detect the coronavirus called an antigen test.

The test looks for protein fragments associated with the virus. The sample is collected with a nasal swab. It can produce a result in minutes, the FDA said in a statement. The agency notes that compared to already approved genetic testing, the antigen test is cheaper and easier to use and could “potentially scale to test millions of Americans per day” once multiple manufacturers enter the market.

So far, only San Diego-based Quidel Corporation has received authorization for the tests. That authorization was granted late Friday.

Two other types of tests for the coronavirus have received the emergency authorization. One, called a polymerase chain reaction, or PCR test, is a molecular diagnostic tool that identifies the virus’s genetic material. The other is an antibody test.

Antigen testing is not without its shortcomings. The FDA notes that test is less reliable at ruling out infection in patients and that negative results “may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.”

“Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests,” the agency said. “This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection.”

The FDA says it expects more antigen tests to be authorized and that it “will play a critical role in the fight against COVID-19.”

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Emergency Issues

FDA Issues Emergency Authorizations for Antibody Test and NASA Ventilator – Contagionlive.com

New Total COVID-19 Antibody Test Receives FDA Emergency Use Authorization

The FDA has granted Bio-Rad Laboratories Emergency Use Authorization (EUA) for the company’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Total Ab test. This test is the first total antibody test that has received an EUA from the FDA.

The blood-based immunoassay test will be able to help clinicians identify whether an individual has antibodies against SARS-CoV-2, the virus associated with coronavirus disease 2019 (COVID-19).

The test will be available for use both manually or on an automated immunoassay platform.

Read the full article.


FDA Authorizes NASA Developed Ventilator for COVID-19

The FDA has added a ventilator developed by the National Aeronautics and Space Administration to the list of authorized ventilators under the FDA’s ventilator emergency use authorization.

The original emergency use authorization was issued out of concern related to an insufficient supply of FDA-approved ventilators for use in health care settings during the coronavirus disease 2019 (COVID-19) pandemic.

Read the full article.

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