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FDA Okays Off-label Coronavirus Treatment: What You Need to Know

March 30, 2020

March 30, 2020
By Naomi Lopez and Christina Sandefur

America continues to grapple with a healthcare crisis that’s unlike anything we’ve ever experienced, but help may be on the way for some of the sickest coronavirus patients. Over the weekend, the U.S. Food and Drug Administration (FDA) issued an emergency authorization that will facilitate the broad use of chloroquine and hydroxychloroquine for the treatment of hospitalized patients.

Naomi Lopez, Director of Healthcare Policy at the Goldwater Institute

The emergency authorization for this off-label, potential treatment is an important and positive step, arming healthcare providers with the needed information and product supply that, if and when appropriate, can be used to treat those patients who are out of an already very limited range of treatment options. Here’s what you need to know about this possible coronavirus treatment:

What are the current treatments for COVID-19?

There are currently no FDA-approved vaccines or treatments for COVID-19. There are potential vaccines and treatments now in FDA clinical trials, but these are many months or, in some cases, years away from approval. Treatments already being tested in clinical trials to treat other illnesses may also be effective for this virus, and manufacturers are revisiting abandoned trials for drugs that might also be effective.

What is off-label treatment?

Many hospitals across the country have reported using chloroquine or hydroxychloroquine, often in combination with Zithromax, commonly known as a Z-Pak, as a treatment for in-hospital COVID-19 patients. Chloroquine and hydroxychloroquine are FDA-approved for malaria, lupus, and rheumatoid arthritis. Zithromax is an FDA-approved antibiotic.

This treatment is based on early clinical findings from around the world, as well as the initial experiences of physicians treating patients on the front line here in the U.S. These treatments are just now being tested here in the U.S. under the FDA’s clinical trial evaluation process.

Although these drugs are FDA-approved to treat other illnesses, they are not approved separately or in combination to treat COVID-19. Prior to the emergency authorization, doctors were already able to legally prescribe them to treat COVID-19. Prescribing medicines to treat conditions other than what the FDA approved that medicine to treat—called “off-label uses”—is legal and common. In fact, roughly 20 percent of all prescriptions are off-label.

Unfortunately, federal laws sometimes prevent drug manufacturers from sharing important information about off-label uses and violating those rules can result in criminal prosecution and penalties. Of course, the ability to share truthful, scientific, and up-to-date information about off-label treatments is critical to ensuring doctors can provide the best treatments for their patients, especially when lives are at stake. The Goldwater Institute is working to reverse this FDA gag order.

What is an emergency authorization (EA)?

Using authority established by the nation’s public health emergency laws, the FDA granted an emergency authorization request to make chloroquine and hydroxychloroquine available from the Strategic National Stockpile (SNS), the federally operated supply of medical equipment and pharmaceuticals for use in public health emergencies. The authorization will distribute tens of millions of doses, some of which have been recently donated to the SNS, to states’ public health authorities.

The treatments are being made available to adolescent and adult patients who are hospitalized with COVID-19 when those patients do not qualify or are unable to participate in a clinical trial. Under the authorization, hospitals will be required to monitor patient results, including bad results—or “adverse events”—and report them to the FDA.

The FDA issues emergency authorizations when it believes that potential effectiveness of the treatment outweighs potential safety concerns. The Goldwater Institute applauds the FDA for using its emergency access powers when lives hang in the balance, but it has been critical of the Agency’s past tendencies to withhold information from the public about how it makes these critical— sometimes life-or-death—decisions. Just last week, the Institute won a major legal victory when the Ninth Circuit Court of Appeals ruled that the FDA could not hold back information about its decision to authorize emergency use of the drug ZMapp, a treatment that had never even been tested on humans, to two American aid workers during the Ebola outbreak secret because the Agency wanted to avoid sharing any information about how it reached its decision. Fortunately, in this case, the FDA shared its rationale as it relates to both patient risk and potential treatment effectiveness to make this authorization.

What about shortages for other patients?

This is a real concern as patients with lupus and rheumatoid arthritis are reportedly facing shortages and delays in filling their needed prescriptions at their local pharmacies. Some states have enacted fill limits to 30 days, while others are actively discouraging physicians against writing prescriptions for these medicines for stockpiling purposes.

The donation to and release of treatment doses to the Strategic National Stockpile should help alleviate these shortages. The sharing of truthful and scientific information about the off-label uses of these treatments should also provide needed guidance.

When lives hang in the balance, getting the right treatment, to the right patient, at the right time sometimes means making investigational and off-label treatments available today. Hopefully, the FDA’s emergency authorization here will help stem this deadly outbreak.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute. Christina Sandefur is the Executive Vice President at the Goldwater Institute. They are co-authors of the 2018 study, Restoring Free Speech in Medicine: How state lawmakers can overcome FDA regulations that keep doctors and payers in the dark.



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