Monday, March 30, 2020

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.

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