The FDA and COVID-19: Will Mt Olympus Let us Test?

This was originally written as an op ed on March 25th, 2019. Prominent papers were considering publishing it, but we were told at least one worried about their relationship with the FDA and that they did not want to criticize them directly at this time and risk losing contact during a crisis.

The FDA does not have an easy job — but it’s well known that the FDA is overly risk averse, causing far more damage with what they do not allow than the lives saved. Its insular, bureaucratic decision-making is not set up for a pandemic. In this crisis we need our leaders to be aware of this, and to push the FDA to communicate about what they are thinking so that outsiders can help solve problems—for instance, ramp tests — and to take calculated risks.

So far our leaders have failed on this front. On top of that, the culture of the FDA is such that if you criticize it, you are spurned. The level of arrogance extends to pretty much everyone around the organization. Thus the FDA has been allowed to inappropriately delay key responses to COVID-19, even with the economy and lives on the line.

This is a totally unacceptable situation. We will have to go in and revamp the insular culture of the FDA, forcing more transparency and establishing internally competing teams to speed up various key work. In the meantime, tests are sitting on shelves and we need public rules for telemedicine-administered at home tests.

Since the writing of this piece, Abbott Labs produced a new in-clinic test that should help ramp testing a lot. Further antibody-detection serology tests should become widespread as well, and will allow us to see who is immune so that we can get people back to work. The country is moving — too slowly — in the right direction.

— JTL, March 29, 2020

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Coronavirus test-kits are our eyes and ears in this pandemic, crucial to navigating disease containment and economic recovery. But because of recent F.D.A. guidance prohibiting at-home testing for COVID-19, hundreds of thousands of verified COVID-19 tests are sitting idle on laboratory. The Trump Administration must immediately appoint a leader at the F.D.A. who can partner with the private sector and put forward clear rules to deliver widespread at-home testing.

The F.D.A.’s missteps in diagnostics regulation earlier in the year have already cost us many lives and livelihoods. Even as it became clear that the C.D.C.’s first batch of tests were flawed, the F.D.A. blocked research laboratories from producing and administering their own tests. Not until February 29th did the F.D.A. release guidance allowing independent labs to start testing. By then the virus had already taken root in the United States for over a month, with the number of infected doubling every six days. Even now, testing in the U.S. still lags behind the much of the world, with just over 1,500 tests per million people. South Korea has run nearly 7,000 tests per million people in comparison.

Yet just last week the F.D.A. stopped a group of startups that had released at-home sample collection kits that could rapidly expand America’s testing capacity. One startup, Nurx, primarily facilitates at-home testing for sexually transmitted diseases. Nurx opted to supply oral swabs for at-home sample collection supporting COVID-19 testing after its partner laboratory proved the fidelity of this technique.

All of Nurx’s tests were physician-ordered based on C.D.C. criteria and were processed in CLIA-certified laboratories. But on March 21st, as soon as reports of at-home tests surfaced, the F.D.A issued guidance that at-home sample collection was unauthorized and “fraudulent”, possibly because they were afraid people couldn’t administer the swabs appropriately themselves. The F.D.A. did not explain. Companies had to halt all testing and destroy the samples they had collected.

Just days after pulling at-home test kits out of the market, the F.D.A. announced on Monday that nostril swabs — which are easier to self-administer and less hazardous than the standard nasal cavity swabs — could be used for testing in a clinical setting. Yet the at-home ban continues without explanation.

The F.D.A. is certain to allow at-home sample collection eventually. The F.D.A. admits on its website that home tests are needed to meet testing demand. Telemedicine-directed, self-collected samples are safer as well because they do not require a nurse to risk exposure from a patient.

Should at-home sample collection only be allowed if administered by doctors [over telemedicine], as some companies are confident works well? Is the standard swab now maybe okay — as they hint — or is the deeper test necessary? Are they still deciding? If the F.D.A. would discuss this openly, as an intellectual partner not just to the connected few but to all of us, we could solve for their objections and be ready to scale tests faster. Unfortunately we have received no comment from the F.D.A.; those not atop Mount Olympus are not privy to such information. The gods work at their own pace and rarely speak to mortals.

Other innovative companies that have raised hundreds of millions of dollars, such as 23andMe and Him & Hers, can repurpose laboratories to test for COVID-19 at scale and use telemedicine to approve and administer tests remotely. With clear rules, we can scale these tests massively, right away.

Workers in essential industries like food production and grocery stores need to be able to get tested conveniently and quickly, without risking exposure to COVID-19 in an overcrowded hospital. The healthcare system should know the status of as many people as possible in order to allocate resources appropriately and effectively protect the public. At scale, to get the country back to work, home tests are the only viable solution.

Our country can no longer afford to allow business as usual at the F.D.A. We need faster decisions, and clear communication — we need a real partner, not an indecisive bureaucracy.

It’s inspiring to see America’s entrepreneurs — the best in the world — rise eagerly to confront this challenge, supporting our healthcare workers on the front line and working on solutions for PPE supplies, therapeutics, tests, and more. When our country is at its best, ideas compete openly and the best solutions win, driving progress. But when administrators make decisions without bothering to justify themselves, it is not the best ideas that win, but the best-connected.

I am confident that the F.D.A. will eventually allow for at-home sample collection with clear rules. In the meantime, how many more lives will we sacrifice to their bureaucratic intransigence?

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