October 1, 2020
By Naomi Lopez
With the flu season approaching and the prospect of another round of lockdowns, there is much hope that COVID-19 vaccines may be available in the coming months, under emergency authorization by the U.S. Food and Drug Administration (FDA) or via full FDA approval. But for all the effort in removing clinical obstacles and bureaucratic delays, one FDA policy is keeping doctors in the dark and standing in the way of treatments that could be crucial in our nationwide fight against the virus.
Today, about one in five prescriptions is written off-label, meaning a treatment is prescribed for a different condition or dosage than what the FDA has approved. But while prescribing a treatment off-label is legal, talking about it is not: An FDA “gag rule” prevents manufacturers from sharing truthful and scientific information about off-label usage. In fact, a manufacturer who shares truthful and scientific information about off-label uses for their drug can face criminal penalties and prosecution. And during the COVID-19 pandemic, this gag order has resulted in medical directors and doctors swapping anecdotes though social media and group texts more often than might have otherwise occurred.
While it is true that there are no FDA-approved treatment or vaccine for COVID-19, many FDA-approved treatments for other illnesses show some promise in the battle against the virus, adding hope that already available, inexpensive, and effective treatments can change the course of this illness — at least until COVID-19 approved treatments are readily available. According to BIO, a biotechnology industry trade group that is tracking the COVID-19 pipeline of antivirals, treatments and vaccines, 30 percent of treatments under clinical investigation are repurposed drugs. Of the 175 vaccines under clinical review, five are repurposed and four are in Phase 3 clinical trials, which is the final evaluation phase before a drug is eligible for FDA approval for that use.
In order to better facilitate the exchange of information for off-label treatments, the FDA has promoted and updated its crowdsourced medical platform, CURE ID, which is a joint project of the FDA and the National Center for Advancing Translational Sciences (NCATS). At first glance, it might appear that the FDA is harnessing modern communications tools to promote and advance treatment options.
But upon closer scrutiny, one is left wondering: If the goal is transparency and time is of the essence, why are doctors being denied useful information when it comes to the full range of treatment options when manufacturers can likely contribute to that knowledge? This is particularly important when one understands that these treatments are often the standard of care, especially in areas that are being hard-hit by the virus, even when more complete information is lacking.
Lawmakers in the states are increasingly turning their attention to this important issue. So far, Arizona and Tennessee have both passed laws that protect the sharing of truthful and scientific information with doctors and insurers. Other states will likely follow suit over the next several years. But the FDA, with or without congressional or executive directive, already has the authority to change its policy.
Herculean efforts to getting the right treatment to the right patient at the right time are laudable and fully effective when they are not undermined by internal and conflicting rules and red tape. Unfortunately, the outdated off-label gag rule continues to block the path to achieving that goal. Forcing medical directors and doctors on the frontline to peddle anecdotes about already-available treatments that might be helpful in the COVID battle — at a time when the availability and accessibility of information has never been greater — is nothing short of absurd, because it is hindering both scientific progress and the prioritization of potential treatments to the patients in dire need. It is time to rescind this policy that is not only outdated but is likely limiting treatment options at a time when doctors and their patients need them most.
Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.