FDA Should Expand Options for Coronavirus Patients

March 26, 2020

The race is on to get medical supplies to struggling patients as COVID-19 continues to get worse. In repeated press conferences, the Trump administration has promised the continued, large-scale manufacture and delivery of products such as masks, gloves, and coronavirus tests. While President Trump rightly refuses to invoke the Defense Production Act to directly produce these supplies via nationalization, he has used the threat of this far-reaching statute to keep companies at maximum production. But all of the expedited manufacturing in the world won’t make much difference as the Food and Drug Administration (FDA) continues to drag its feet in inspecting, testing, and approving life-saving products and medicines. The agency must roll back the red tape holding up care for millions of Americans.

Needless to say, the FDA isn’t moving quickly enough to protect people during the coronavirus pandemic. After the Centers for Disease Control and Prevention bungled the early rollout of Coronavirus testing, the FDA waited weeks to allow laboratories across America to develop their own tests. But, even with this green light, the FDA continues to hold up the public health response to the pandemic. According to Washington Examiner journalist Tom Rogan, “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…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.” This couldn’t come at a worse time, as protective gear shortages are compromising care for the estimated 35,000 Americans who have the coronavirus.

For example, at Barnes Jewish Hospital in St. Louis, The New York Times reports that physicians undertaking invasive surgeries have had to use loose-fitting surgical masks in lieu of tight, recommended respirator masks. But fear not – the FDA “may consider expedited review of manufacturing site changes or premarket submissions” and companies are welcome to discuss mitigation approaches for products in shortages. While the FDA is committing to an “open door” approach, not much will happen unless the FDA allows boxes of critical supplies to be shipped to healthcare facilities and opened by experienced care providers. Since the agency is already permitting licensed pharmacists and doctors to make their own hand sanitizer, surely it isn’t a stretch to let doctors ascertain the quality of masks and gloves for themselves.

The clock is ticking for the FDA to prove to the nation that it’s willing to abandon the agency’s past risk aversion. There’s already plenty of discussion over expediting potential cures to the coronavirus, especially after President Trump tweeted on March 21 that anti-malaria drug hydroxychloroquine and antibiotic azithromycin “have a real chance to be one of the biggest game changers in the history of medicine” as a one-two punch. The agency recently allowed patients access to hydroxychloroquine (along with the investigational antiviral medication remdesivir) under its “compassionate use” framework, which allows patients with a serious or life-threatening illness access to experimental medications following a formal request process.

But the surge in requests for access to remdesivir has forced drug manufacturer Gilead to bar new requests following the treatment of just 250 patients. The company states that, “we are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.”

Drug manufacturers such as Gilead are doing their best but are stymied by a bureaucratized system that prevents patients in harm’s way from getting access to promising medications. It’s time to let patients and their doctors come to informed decisions about how to treat a deadly disease without applications and middlemen getting in the way. Clinical trials are an absolute must, but in the meantime, countless patients have little to lose by giving medications such as hydroxychloroquine a try. The FDA should consider allowing the use of unapproved medications as long as patients sign a waiver and understand the risks.

The FDA should be leading the way in waiving inspection requirements and allowing greater use of promising drugs. Millions of lives depend on it.