townhall.com
Hydroxychloroquine Gets FDA Emergency Authorization for Treatment of Wuhan Coronavirus
The Food and Drug Administration granted hydroxychloroquine emergency use authorization on Sunday. The authorization comes amid a large clinical trial currently underway in New York and growing evidence that suggests the drug may be an effective treatment for patients infected with the Wuhan coronavirus.
(Hydroxy)chloroquine is an inexpensive drug widely used since 1955 to treat malaria. Given the drug's relatively harmless side effects, doctors are already beginning to incorporate the drug in their treatment of coronavirus cases. President Trump and New York Gov. Cuomo have both expressed optimism over the drug's efficacy.
The world is currently in the middle of a pandemic and the luxury of time simply doesn't exist for the typical regulatory processes. With few alternatives, why not let doctors prescribe (hydroxy)chloroquine to patients, the vast majority of which could only stand to benefit from receiving the medicine?
"Let's see how it works," Trump said at a press briefing on Sunday. "It may. It may not."
The FDA is allowing drugmakers to donate the medicine "to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," HHS announced in a statement. Sandoz Pharmaceuticals donated 30 million doses of hydroxychloroquine and drugmaker Bayer donated one million doses of chloroquine to the stockpile.
When Trump expressed optimism about the relatively safe drug's potential use as an effective treatment for the Wuhan coronavirus, kneejerk Democrats, like Michigan Governor Gretchen Whitmer and Nevada Governor Steve Sisolak, moved to restrict access to the potentially life-saving medicine.
Drugmakers have already ramped up production of (hydroxy)chloroquine in response to the increased demand. The focus at this point should be making more of this potentially life-saving drug, not restricting its use amid a global pandemic. The FDA's emergency authorization of (hydroxy)chloroquine should allow drugmakers to do just that.
politico.com
FDA issues emergency authorization of anti-malaria drug for coronavirus care
The drugs have been championed by President Donald Trump for treatment despite scant evidence.
The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.
The agency allowed for the drugs to be "donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.
The move was supported by the White House, part of a larger Trump-backed effort to speed the use of anti-malaria drugs as a potential therapy for a virus that has no proven treatment or cure. FDA already has allowed New York state to test administering the medication to seriously ill patients, and some hospitals have added it to their treatment protocols.
"Let's see how it works," Trump said at a press briefing on Sunday, referencing New York state's efforts. "It may. It may not."
Career scientists have been skeptical of the effort, noting the lack of data on the drug’s efficacy for coronavirus care and worried that it would siphon medication away from patients who need it for other conditions, calling instead for the agency to pursue its usual clinical trials.
Three officials told POLITICO that FDA’s planned move would facilitate more access to the drug by allowing more manufacturers to produce or donate it.
Hydroxychloroquine, which is already available commercially in the United States, is commonly used to treat malaria, lupus and rheumatoid arthritis. The drug also has been touted as a therapy for coronavirus by an unusual assortment of investors, TV correspondents and even some advisers to the White House — including some advocates who overstated their claims and credentials — and been championed by guests on Fox News. |
