Millions Of Hydroxychloroquine Pills That Trump Touted For COVID-19 Are Now In Limbo
Dozens of millions of doses of medication that President Donald Trump has hailed as a game changer in the fight against coronavirus are now pending after the Food and Drug Administration withdrawn their emergency approval this week.
The drugs - hydroxychloroquine sulfate and chloroquine phosphate - were considered too risky and probably ineffective in the treatment of COVID-19.
The FDA's decision on Monday, which a Trump official denounced as partisan attack, follows an insane decision by states and hospitals to buy chloroquine and hydroxychloroquine after health care providers gave the go-ahead for the use of the drug in March by approving it for emergency use had received. The drugs were otherwise not approved for the treatment of COVID-19.
"What do we have to lose?" Trump asked at a press conference on March 21 that advocated drugs.
FDA drug information
Based on ongoing review of scientific data, the FDA has determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating # COVID19. We therefore withdraw the approval for emergencies for these drugs:
7:50 p.m. - June 15, 2020
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Manufacturers announced in mid-March that they had ramped up production of their medicines worldwide to meet expected demand. However, it is now unclear what will happen to the oversupply.
According to the New York Times, the federal supply contains 66 million doses of the medication. These include 3 million tablets of Resochin, Bayer's chloroquine phosphate drug that the company donated but is not approved for use in the United States.
Bayer's donation should be used "as the government deems appropriate," a Bayer representative said in an email to HuffPost.
The US Department of Health "is working with companies that donated hydroxychloroquine sulfate and chloroquine phosphate to determine the options available for the remaining products," said Stephanie M. Bialek, director of communications services for Strategic National Stockpile HuffPost Wednesday.
Similar responses were sent to HuffPost by public health officials for states that either bought the medication or received donations.
President Donald Trump, who was seen in May, called the anti-malaria drugs chloroquine and hydroxychloroquine "game changers" in the fight against the corona virus. (Photo: MANDEL NGAN via Getty Images)
"We are in the process of contacting the manufacturer to see if we can return the hydroxychloroquine for other purposes," Mindy Faciane, a Louisiana Department of Health information officer, told HuffPost.
"We are considering plans for the remaining doses," said Erin Silk, spokeswoman for the New York State Department of Health.
The North Carolina Department of Health "is currently reviewing what to do with available supplies," said communications manager Kelly Haight Connor.
New Jersey Amneal Pharmaceuticals donated medicines to Louisiana, New York, North Carolina, Connecticut, Oregon and Texas, according to an April Associated Press report.
Other states spent hundreds of thousands of dollars on the drugs, the AP reported.
The FDA issued emergency approval in March for the chloroquine and hydroxychloroquine antimalarials used to treat COVID-19. This approval was revoked on Monday. (Photo: ASSOCIATED PRESS)
Utah was able to cancel his order before it arrived, a Utah Department of Health representative told HuffPost.
In Ohio, "we're working on a plan," a health care official told HuffPost.
Oklahoma has reportedly spent $ 2 million on the drugs. A representative from the State Department of Health did not respond to HuffPost's request for comment.
In the first 17 days of March, orders from hospitals for chloroquine increased nationwide by 3,000 percent, while orders from hydroxychloroquine increased by 260 percent, according to the healthcare company Premier, which tracked purchasing data from 4,000 U.S. hospitals and healthcare systems.
Amneal Pharmaceuticals announced on March 20 that approximately 20 million hydroxychloroquine sulfate tablets are expected to be manufactured by mid-April.
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Workers carry boxes in Oklahoma's warehouse for strategic national stocks in Oklahoma City in April. The states spent billions of dollars on medical supplies such as masks and breathing apparatus during the coronavirus pandemic. (Photo: ASSOCIATED PRESS)
Large wholesalers restricted ordering medication to prevent hoarding. However, this only happened after an increase in demand, which suggests that, according to Premier, many healthcare providers had already stocked up on large quantities of the medication.
An Amneal representative did not respond to HuffPost's request for comment.
Chloroquine phosphate and hydroxychloroquine sulfate are still approved by the FDA to treat or prevent malaria, according to the Centers for Disease Control and Prevention. This is a mosquito-borne disease that affects about 2,000 people each year in the United States, typically after traveling or overseas immigration.
Hydroxychloroquine is also approved by the FDA for the treatment of autoimmune diseases such as rheumatoid arthritis, which affects an estimated 54.4 million people in the United States.
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