Thursday, March 19, 2020

Running smoothly

The FDA is so desperate for information about shortages in coronavirus testing supplies that it is turning to an unlikely source of information: Twitter.

Wading into the Wild West of social media for help during a global pandemic may seem unsophisticated for an agency charged with regulating the nation’s drugs and medical devices. But thanks to a decades-old law, the FDA cannot require device manufacturers to report shortages in the same way it can for drugmakers.

This fundamental gap in the flow of information has made it difficult for the FDA to identify weaknesses in the supply chain for coronavirus testing and in the nationwide push to test hundreds of thousands of patients.

[...]

So the FDA is making plaintive appeals on Twitter, in addition to negotiating with companies behind the scenes.

“@US_FDA suggests companies make public their inventory, production schedule and a hotline number to address questions regarding availability of reagents and other supplies needed for #COVID19 testing,” Anand Shah, the agency’s deputy commissioner for medical and scientific affairs, tweeted on March 17. “If you have an allocation plan to maximize efficient testing, please post.”

The FDA is seeking information about swabs, test kits, instruments and supplies for transporting and preparing samples for analysis, Shah said in a subsequent tweet that tagged the @FDADeviceInfo account.

  Politico
We can all stop worrying. Twitter is on it.
Sen. Josh Hawley (R-Mo.) introduced a bill in February to bolster FDA’s authority to monitor device shortages, and Sens. Kelly Loeffler (R-Ga.) and Bob Casey (D-Penn.) unveiled similar legislation in March.

But with those proposals in legislative limbo, the agency may have to get creative to track potential shortages at a time when countries around the world are competing for the same basic testing supplies.
Why is that legislation in limbo? Could it have anything to do with Mitch McConnell? Rhetorical question.

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