Dealing with the FDA in peacetime meant delays, but those were only serious to manufacturers and some patients. Now the FDA is becoming a serious obstacle in a crisis.
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.
Obviously we don’t want unscrupulous folks taking advantage of the crisis, but at the same time we ought to be able to move mask shipments and deliveries forward without endless inspections.
The FDA blocked the testing we needed that might have done a better job of heading things off.
Some of the nation’s best academic laboratories wanted to begin developing their own coronavirus diagnostic tests early last month, but were blocked by federal rules about test development.
This is going to be a real issue with drug development.
In many ways Trump’s science policy has been defined by his disdain for red tape at the FDA. At nearly every turn he has equated the agency’s success not with its scientific rigor or its role as a watchdog but with faster drug approvals and the slashing of regulations.
Shortly after being elected, Trump turned to billionaire Peter Thiel to help vet candidates to lead the FDA and other science agencies. Among those candidates was Jim O’Neill, a staunch libertarian, who championed the idea of letting the FDA approve drugs without proving they were effective. During his first address to Congress, in 2017, Trump chided the agency for its “slow and burdensome” approval process, despite the fact that the FDA in recent years had acted faster than ever before.
And he has repeatedly touted the passage of the so-called “right to try” law — which gives dying patients access to experimental drugs that have completed basic Phase I clinical trials — despite expert concerns about it.
Still, the bracing pace may not be enough for Trump. The Wall Street Journal reported this week that the White House pushed for an executive order dramatically expanding the use of investigational drugs against the coronavirus, but was met with objections from the FDA
The FDA has been wrong about its coronavirus response at every turn. President Trump would be right to override the FDA.