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Collage of four photos showing a doctor's hands holding a prescription medicine bottle while signing a prescription, a senior female patient in a hospital gown, a medical worker drawing a drug from a vial with a syringe while wearing full PPE, and a senior male at home reading labels on multiple prescription drug bottles

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. Equally a medico, my center breaks for the patients and their families. I as well desire to express admiration for my peers in the medical community who are doing everything they tin can to treat patients ill with this novel affliction that nosotros proceed to larn virtually every day.

At the FDA, our public wellness concern is for the American people, and much like the wellness care professionals on the frontlines, our team of 18,000 strong are using their years of expertise to make decisions based on the all-time science and data at mitt during this unparalleled public health emergency.

photo of Stephen M. Hahn, M.D.

Stephen Thou. Hahn, M.D.

I surface area where in that location's been tremendous public interest is potential prevention and handling options. The FDA plays a pivotal role in this work to both assist move new medical products to patients as soon as possible, while at the same fourth dimension make up one's mind whether they are constructive and if the benefits outweigh the risks.

For example, nosotros'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 linguistic communication used to draw potential therapies can exist 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 intendance providers and patients to hear my perspective directly.

Like many doctors making treatment recommendations for patients, equally a cancer md, 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 handling "off-characterization" if information technology was in the best involvement of their patient. Prescribing a product for uses not specifically included in the official labeling is common in the do of medicine. In oncology and mental health, many patients are treated this fashion.

Doctors explain to patients that any recommended treatment, whether investigational or well-established, carries risks, simply brand sure that they understand why and how a handling 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 make up one's mind whether the treatment should exist changed. Treatment plans and any possible changes are always a give-and-take between the patient and physician based on an understanding of the patient'due south condition as well as relying on training and feel.

The drugs hydroxychloroquine and chloroquine have received particular attention. Both are FDA-approved to treat or prevent malaria, and hydroxychloroquine is as well canonical to care for autoimmune atmospheric condition such equally chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. They have been prescribed for years to aid patients with these debilitating, or fifty-fifty deadly, diseases and have a well-established condom contour for these conditions.

While they are not approved to prevent or treat COVID-19, they take been the topic of much scientific give-and-take since the emergence of this virus and are the field of study of numerous clinical trials.

Many physicians accept also prescribed these drugs for patients with COVID-19 based on an private cess of the potential benefits versus the risks for an individual patient. The agency neither endorses individual prescribing decisions nor prohibits physicians from prescribing medications. Nosotros practice not regulate the do of medicine. Of course, nosotros provide information to physicians about medications such as hydroxychloroquine or chloroquine so that they can brand the best decision in the interest of their patient'south wellness. It is important that patients and health care providers empathize the known side effects of these drugs, including serious and potentially life-threatening heart rhythm issues as noted in a recent Drug Safety Communication.

At the same time, it's as well disquisitional that patients who have been prescribed these products for systemic lupus erythematosus and rheumatoid arthritis understand that the FDA's blessing means the bureau has determined them to be condom and constructive for those conditions.

To meet the evolving demands of the pandemic, the FDA too issued an EUA that allowed for additional supplies of canonical 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-nineteen 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 prove available at that fourth dimension. We continue to expect at the data on hydroxychloroquine and chloroquine and we will make futurity determinations on these products based on available evidence including ongoing clinical studies.

Since the hydroxychloroquine product is FDA-canonical for other uses with a prescription, the donation agreements also allowed for it to exist distributed for clinical trials and to the commercial market for utilise in the outpatient setting, if appropriate. We also knew it was important to aid ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand.

Nosotros empathise that health care professionals are looking for every possible treatment pick for their patients. A patient and their doctor must ultimately make up one's mind what treatment is likely to exist all-time for the private patient. I consider the relationship that I, and other physicians, develop with their patients to exist sacred and one in which both parties feel confident that they tin can be open up and frank most personal medical matters.

As wellness care providers keep to use their medical judgement to recommend the best form of treatment for an individual patient, the FDA – driven by the urgency to piece of work speedily to address this unprecedented situation – has used and will continue to use the bachelor scientific discipline and data to ensure those on the frontlines have the tools and information necessary to combat this pandemic.

Additional Resources:

  • Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-xix