By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs
In hospitals all across this country, doctors continue to deal with the influx of COVID-19 cases. As a doctor, my heart breaks for the patients and their families. I also want to express admiration for my peers in the medical community who are doing everything they can to treat patients ill with this novel disease that we continue to learn about every day.
At the FDA, our public health concern is for the American people, and much like the health care professionals on the frontlines, our team of 18,000 strong are using their years of expertise to make decisions based on the best science and data at hand during this unparalleled public health emergency.
One area where there’s been tremendous public interest is potential prevention and treatment options. The FDA plays a pivotal role in this work to both help move new medical products to patients as soon as possible, while at the same time determine whether they are effective and if the benefits outweigh the risks.
For example, we’ve issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir and facilitated emergency access to the blood-related therapy called convalescent plasma.
Recognizing that the technical regulatory language used to describe potential therapies can be confusing and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments, we’re providing a resource for consumers on many of these terms and wanted to take an opportunity for health care providers and patients to hear my perspective directly.
Like many doctors making treatment recommendations for patients, as a cancer doctor, I made my evaluation of which approved treatments or investigational or experimental therapies could help my patient based on what I knew about the individual patient and their disease progression.
There were times when doctors needed to consider the use of an FDA-approved drug or treatment “off-label” if it was in the best interest of their patient. Prescribing a product for uses not specifically included in the official labeling is common in the practice of medicine. In oncology and mental health, many patients are treated this way.
Doctors explain to patients that any recommended treatment, whether investigational or well-established, carries risks, but make sure that they understand why and how a treatment path was recommended. And if something new is learned about a patient’s disease during treatment, or about the benefits or risks of relevant treatment options, evaluation typically occurs to determine whether the treatment should be changed. Treatment plans and any possible changes are always a discussion between the patient and physician based on an understanding of the patient’s condition as well as relying on training and experience.
The drugs hydroxychloroquine and chloroquine have received particular attention. Both are FDA-approved to treat or prevent malaria, and hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. They have been prescribed for years to help patients with these debilitating, or even deadly, diseases and have a well-established safety profile for these conditions.
While they are not approved to prevent or treat COVID-19, they have been the topic of much scientific discussion since the emergence of this virus and are the subject of numerous clinical trials.
Many physicians have also prescribed these drugs for patients with COVID-19 based on an individual assessment of the potential benefits versus the risks for an individual patient. The agency neither endorses individual prescribing decisions nor prohibits physicians from prescribing medications. We do not regulate the practice of medicine. Of course, we provide information to physicians about medications such as hydroxychloroquine or chloroquine so that they can make the best decision in the interest of their patient’s health. It is important that patients and health care providers understand the known side effects of these drugs, including serious and potentially life-threatening heart rhythm problems as noted in a recent Drug Safety Communication.
At the same time, it’s also critical that patients who have been prescribed these products for systemic lupus erythematosus and rheumatoid arthritis understand that the FDA’s approval means the agency has determined them to be safe and effective for those conditions.
To meet the evolving demands of the pandemic, the FDA also issued an EUA that allowed for additional supplies of approved hydroxychloroquine and unapproved chloroquine that was tested by the FDA and donated to the Strategic National Stockpile to be used in the treatment of certain patients hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible.
This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time. We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies.
Since the hydroxychloroquine product is FDA-approved for other uses with a prescription, the donation agreements also allowed for it to be distributed for clinical trials and to the commercial market for use in the outpatient setting, if appropriate. We also knew it was important to help ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand.
We understand that health care professionals are looking for every possible treatment option for their patients. A patient and their doctor must ultimately decide what treatment is likely to be best for the individual patient. I consider the relationship that I, and other physicians, develop with their patients to be sacred and one in which both parties feel confident that they can be open and frank about personal medical matters.
As health care providers continue to use their medical judgement to recommend the best course of treatment for an individual patient, the FDA – driven by the urgency to work quickly to address this unprecedented situation – has used and will continue to use the available science and data to ensure those on the frontlines have the tools and information necessary to combat this pandemic.