June 5, 2020
By Naomi Lopez and Christina Sandefur
Regulatory roadblocks are keeping Americans from getting the rapid, responsive healthcare we need — and the saga of a Seattle-based diagnostic testing program is just the latest example of how red tape is tying our hands in the fight against COVID-19.
Recently, U.S. Food and Drug Administration (FDA) regulators ordered a halt to the Seattle Coronavirus Network Assessment (SCAN), a program that aims to test patients for exposure to COVID-19. Promoted by Bill Gates, it had already been authorized by the state and included technical assistance from the federal Centers for Disease Control and Prevention (CDC). Yet the FDA shut it down because it had not received bureaucratic authorization to share the result of self-administered tests with program participants.
You read that right: The FDA was fine with testing — and nobody claims the test is unreliable or dangerous — but without bureaucratic approval, the SCAN program may not tell patients the results of their self-administered tests. Sadly, this kind of FDA red tape is typical of our increasingly obsolete system of medical regulation.
The FDA deserves credit for taking steps in recent months to speed up the clinical investigation and approval timeline for COVID-19 treatments. But as the Seattle example shows, there’s still a lot of progress to be made to ensure that Americans receive both the protection and care they need.
We can make that needed progress by opening up the potential in our healthcare system — and there are several ways that we can do that.
Conditional market authorization of treatments still in clinical trials is one avenue. The European Medicines Agency (the EU’s version of the FDA) just announced that remdesivir, which has FDA emergency use approval for hospitalized patients with severe COVID-19, will be made available by physician prescription and for sale for one year while clinical evaluations continue. American law should allow the same conditional authorization process.
We should also harness the important research being done in other parts of the world. Now pending in Congress, the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULTS) for Coronavirus Patients Act of 2020 would speed approval for treatments and vaccines that are already commercially available in certain foreign countries with a stringent treatment approval process. This would let the U.S. benefit from the scientific advances already being undertaken elsewhere.
The FDA’s gag rule on off-label treatments is also hindering our healthcare system. Doctors are already allowed to prescribe federally approved medicines for conditions other than what the FDA approved that medicine to treat. These so-called off-label uses are quite common — roughly 20 percent of all prescriptions are off-label. Yet FDA rules prohibit drugmakers from sharing much of the important information about off-label uses — and violating those rules is punished as a crime. Obviously pharmaceutical companies should be free to share truthful, scientific, up-to-date information about their products with doctors on the frontlines.
Clinicaltrials.gov, the government website that lists important information about ongoing clinical trials in the U.S., should also be updated to include information about medicines available under the recently adopted Right to Try law. These medicines are currently being used to save lives—and have already received safety approval from the FDA — but drugmakers cannot share crucial information with doctors and patients via the government’s online registry. Yet that same registry does include studies for non-approved, potentially dangerous treatments that are not under FDA review and are being administered in places such as Azerbaijan and Togo. This needs to change.
And states should not have to wait for cumbersome federal bureaucracies before protecting their citizens. Allowing states to certify and distribute diagnostic tests during emergencies would prevent a repeat of the Seattle incident.
Sadly, the FDA’s senseless shutdown of the Seattle study is only the most publicized example of the agency’s reluctance to get up to speed with 21st-century medicine. The people who suffer most from this inertia are patients, who are deprived of information about their treatment options. That is why it’s so important for Congress and the President to rein in the FDA’s overreaching and delay. Lives are truly hanging in the balance.