Friday, March 20, 2020

Stockpiles of masks, hand sanitizer, and other supplies are sitting in warehouses waiting for FDA inspectors to get around to them

See Inflexible, bureaucratic FDA is dragging its feet on coronavirus response by Tom Rogan of the Washington Examiner. 
"President Trump is extolling his administration's coronavirus response effort. To that end, Trump says he has massively cut red tape to maximize the government's efficiency.

It sounds good, but Trump hasn't done enough on this score.

At this very moment, stockpiles of masks, hand sanitizer, and other supplies are sitting in warehouses waiting for FDA inspectors to get around to them. Where other nations are expediting these deliveries, trusting proven suppliers in their deliveries, the FDA has resorted to its favorite fetish: bureaucratic lethargy.

The problem here is not simply that the FDA is insisting that its box-checking comes before exigent needs of public health, but also that the agency doesn't have enough inspectors to get the job done quickly.

I spoke to one significant medical supplier who talked to me on the condition of anonymity, for fear of FDA retaliation. In one location on the Pacific coast, this supplier has had more than 20 pallets of coronavirus-specific medical supplies waiting in a warehouse for five days. Yes, five days.

At another depot in the south-central United States, this same supplier has had 500,000 level-three or level-four masks sitting in a warehouse for two days now. They expect the FDA delays to continue indefinitely.

And get this — some of what the supplier is delivering is supposed to be gifted to a hospital. But even in that case, the FDA has warned that the supplies cannot even be unpacked until an inspector arrives. If they are broken down before then, even if only to expedite delivery once the inspector's approval is given, fines are threatened to follow.
It's a joke.

Thus follows a critical question: Does this lethargic FDA response match up with Trump's rhetoric? It does not. And as the coronavirus continues to infect more people, the costs of this failure of government will increasingly be measured in lives lost.

The president needs to pick up the phone to call FDA Commissioner Stephen Hahn and tell him to relax the inspection protocols for trusted suppliers. Either that or Trump can admit he works for the FDA bureaucracy rather than the other way around."

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