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The Unsung Public Health Agency on the Frontlines of COVID-19: The FDA

I’ve talked a lot about the various agencies dedicated to public health at the local, state, and federal levels. One agency dedicated to public health on the federal level that I have not discussed and that you may not know much about is the Food and Drug Administration (FDA). The FDA’s mission states that they are “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”1 Basically, if it goes in your body and is prescribed by a doctor, it’s the job of the FDA to make sure that it’s safe for you. The FDA oversees all drugs (though not supplements2). That means that the from Tylenol in your medicine cabinet to the chemotherapy administered in cancer treatment and everything in between, it all goes through the FDA. That’s a hugely important job. It’s been even more important this year while fighting a novel disease and attempting to find a treatment regimen for it.

The FDA intersects with the COVID-19 pandemic in several ways. Specifically, they oversee the issuance of emergency use authorizations (EUAs) for tests and possible treatments. EUAs allow unapproved medical products or drugs to be used in an emergency (such as a pandemic) for diagnosis, treatment, or prevention purposes.3 EUAs are important to understand because they are not intended for long-term use. They are usually granted with the assumption that clinical trials for the drug or medical product are currently under way and upon the conclusion of those trials, a decision regarding FDA approval will be made. There are a lot of EUAs pertaining to COVID-19.4

The importance of EUAs is that they allow for use of a product or drug if there is reason to think that it may work in a specific instance but there hasn’t been definitive research. EUAs can be issued and then revoked if clinical trials suggest that the drug or product in question is harmful or not beneficial. For example, during this pandemic, there have been six EUAs issued for therapeutics (drugs) to treat COVID-19 and one of those was revoked.5 The EUA that was issued and later revoked was for hydroxychloroquine. The decision to revoke the EUA was due to serious and sometimes fatal side effects of hydroxychloroquine and mounting evidence that it was not effective in treating COVID-19.6

The FDA’s job is to keep you safe in the health care realm. They protect you from harmful devices and drugs. They make sure that the products and drugs going into your body are medically beneficial and generally safe, especially when given under a doctor’s direct supervision. There’s been a lot of misinformation regarding COVID-19 testing and treatments. With so much information bombarding us concerning what can help protect us, diagnose us, and treat us for COVID-19, the FDA is a place where you can go to get some of those questions answered. For example, if you see a claim about how something works to treat COVID-19, it’s simply an internet search away to see if it’s been granted an EUA by the FDA. If it hasn’t, there’s good reason to believe that it’s a scam. The same can be said for devices and tests. The EUAs are a quick litmus test for the rest of us. They help us to determine what way the science is moving in and where it has been. It’s easy to make fantastical claims about a product but it’s not easy to get FDA approval or an EUA. So before you run out to buy the next claimed miracle cure or thing that is supposed to prevent you from getting COVID-19, give it a quick search on the FDA’s website. It just might save you some time, grief, and money.

 

References

  1. Food and Drug Administration. What We Do. https://www.fda.gov/about-fda/what-we-do#mission
  2. Food and Drug Administration. What You Need to Know about Dietary Supplements. https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements
  3. Food and Drug Administration. Emergency Use Authorization. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#abouteuas
  4. Food and Drug Administration. Emergency Use Authorization. Coronavirus Disease 2019 (COVID-19) EUA Information. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covid19euas
  5. Food and Drug Administration. FDA Combatting COVID-19 with Therapeutics. https://www.fda.gov/media/136832/download
  6. Food and Drug Administration. FDA News Release. Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and