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. The agency is responsible for regulating coronavirus tests used by U.S. laboratories.
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.
A spokesperson for the medical device trade lobby AdvaMed told POLITICO that it is working with the FDA “to find the best way to ensure the appropriate information gets to the FDA during this time of crisis.”
The Trump administration has sought to tighten rules for device makers in recent years, bringing them in line with the regulations that require drug manufacturers to warn the government when a shortage seems likely — and how long it could last. The president’s 2020 budget request proposed requiring device-makers to tell the FDA if a significant interruption of essential products was likely, and to file regular reports on their manufacturing capacity.
Similar plans have been gaining steam in Congress. 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. Michael Heyl, a medical device attorney at Hogan Lovells, says that the FDA can glean clues from lists of approved device suppliers to get a window into where companies source materials.
“Those are all available to FDA for review upon inspection,” Heyl said. “An argument can be made that at least who the suppliers are is something that FDA has the ability to see.”
Others argue that a global crisis is not the time to change the rules for device manufacturers.
“There’s a balance that has to be struck between giving that information to FDA and creating additional reporting requirements in a time where people can’t quite keep up with all that they’re required to do already in terms of getting these tests up and running,” said Scott Danzis, an attorney at Covington & Burling who specializes in medical diagnostics.
In the meantime, FDA Commissioner Stephen Hahn told reporters this week that the agency is monitoring the stock of testing supplies and personal protective equipment “very closely.”
“There is pressure on the supply chain with respect to the reagents, swabs, or transport media that are needed to perform these tests,” Hahn said. “We have been leaning in with manufacturers — both of the tests, but also of these other supplies that are needed.”
Source: https://www.politico.com/news/2020/03/18/fda-twitter-coronavirus-testing-136014
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The Article Was Written/Published By: David Lim
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