March 26, 2020
By Naomi Lopez
In the tumult of the unprecedented coronavirus crisis, there is an enormous amount of confusion about potential treatments. Last week, President Trump announced that chloroquine, a treatment used for malaria and arthritis, is now approved for the virus. That was then followed by denials from the U.S. Food and Drug Administration (FDA).
Here’s what we do know: In a time when information is imperative for doctors to more effectively treat this virus, outdated rules are keeping them from getting the information about possible treatments — information that might mitigate this outbreak and potentially save lives.
First, let’s begin by clarifying that there are currently no FDA-approved vaccines or treatments for the symptoms of COVID-19. There are potential vaccines and treatments now in FDA clinical trials, but these are being evaluated for clinical safety and efficacy. In addition, there are treatments already in clinical trials for other illnesses that have promise as also being effective against this virus, and manufacturers are scouring their treatment libraries for abandoned trials that might also be effective.
But an FDA-approved treatment for malaria, lupus, and rheumatoid arthritis — chloroquine — is now being used by some hospitals across the country to treat patients who have the virus. Chloroquine is one of several travel drugs discussed on the CDC’s travel medicine online information. More than a decade ago, my family, including my then-three-year-old, took chloroquine as a prophylaxis as prescribed by our travel medicine doctor before traveling to Costa Rica.
Now, in the midst of the coronavirus crisis, many hospitals across the country are reporting the use of chloroquine or a combination of Zithromax, commonly known as a Z-pack, and chloroquine as a treatment for in-hospital patients. This treatment is based on early clinical findings regarding COVID-19 from around the world, as well as the initial experiences of physicians treating patients on the frontline here in the U.S. These treatments are just now being formally evaluated here in the U.S. as part of the clinic trial evaluation process.
Both drugs, while FDA-approved, are not approved separately or in combination for this virus as yet. But this treatment is legal. When a drug is prescribed but is written for an indication other than an FDA-approved indication, then it is being prescribed off-label. These kinds of prescriptions are extremely common: Roughly 20 percent of all drugs are prescribed off-label. If your child has ever been prescribed amoxicillin for an ear infection, for example, they got an off-label prescription since this antibiotic it isn’t approved for kids.
While it is legal for a physician to prescribe it off-label, FDA gag rules prevent the manufacturer from sharing truthful and scientific information about off-label uses of that drug or combination of drugs. Under current FDA policy, communicating about an approved treatment for a legal, off-label use can result in criminal prosecution and penalties. Now more than ever, physicians need to understand the treatment needs of patients, but many are being kept in the dark without access to full information about treatment options.
The FDA, often with congressional directives, has made important improvements in moving closer toward the goal of bringing the right treatment, to the right patient, and at the right time. But the current gag rules on manufacturers that keep truthful and scientific information about off-label uses may be hindering both scientific progress and the prioritization of potential treatments to the patients who need it most.
Finger-pointing and squabbling about the president’s likely misstatements about confusing and often-murky FDA policy will do nothing to change the fact that outdated rules are standing in the way of doctors accessing the full toolkit of potential treatment options. Truthful and scientific information is needed now more than ever — and government gag rules and red tape shouldn’t stand in the way of doctors learning about potential treatments.
Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.