Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19
Scientists continue to work on developing potential drugs for the prevention and treatment of COVID-19. The language used to describe potential drugs can be confusing.
Here’s what some of those terms mean.
What “FDA Approved” Means
Consumers rely on the U.S. Food and Drug Administration to provide independent scientific reviews of medical products, including therapeutic drugs and vaccines. To meet the urgent need for products to treat or prevent COVID-19, the FDA has approved and authorized several preventative drugs, including vaccines and treatments.
Before the FDA can approve a drug, the agency must determine whether the clinical data and other scientific information show that the drug is safe and effective for its intended use (for example, to prevent or treat a certain disease), and that the product can be made according to federal quality standards.
When the FDA approves a drug, it means the agency has determined that:
- The drug is safe and effective for its intended use.
- The benefits of the drug outweigh its risks when used according to its approved labeling.
The FDA works with manufacturers and researchers to make sure the agency has the information needed to complete drug evaluations to treat or prevent COVID-19 as quickly as possible.
Scientists conduct clinical trials to study investigational drugs to see if they can safely and effectively prevent or treat a specific disease or condition. As part of those clinical trials, they might try to discover:
- How the drug might be used for that disease or condition.
- If the drug is safe for people.
- How much of the drug is needed.
- Information about whether the drug works against the disease and the potential benefits and risks of taking the drug.
Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biological product, or medical device) outside of clinical trials for the purposes of treatment, when there is no comparable or satisfactory alternative therapy. The FDA may authorize treatment with an investigational medical product under expanded access, provided that all the criteria and requirements for expanded access in the FDA’s regulations are met.
Emergency Use Authorization (EUA)
An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly for COVID-19. In certain emergencies, or potential emergencies, the FDA can issue an EUA to provide access to medical products that may be used when, among other criteria, there are no adequate, approved, and available alternatives.
The process for issuing an EUA is different than an FDA approval. Under an EUA, the FDA authorizes uses of medical products based on a reasonable belief that the product may be effective based on the best evidence available at the time, without waiting for all the information that would be needed for an FDA approval. When evaluating an EUA, the FDA carefully balances the potential risks and benefits of the products based on the information currently available. EUAs can also be revised or revoked by the FDA at any time as the agency continues to evaluate the available data to protect public health and safety.
The FDA’s EUA page has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product Fact Sheets and additional information for health care professionals and patients. Learn more about EUAs in this video.
“Off-Label” Use: Unapproved Uses of Approved Drugs
Once the FDA has approved a drug for a disease or medical condition, health care professionals generally may prescribe or administer the drug in clinical practice for an unapproved use not described in the approved labeling (i.e., “off-label”) based on their medical judgment, recognizing that the FDA has not approved the drug for such use.
COVID-19 Vaccines Are the Best Prevention
Vaccination is one of the best ways to protect you and your family from COVID-19. The FDA has approved and authorized vaccines for the prevention of COVID-19. Find a COVID‑19 vaccine and booster near you at vaccines.gov.
If you think you have, or have had, COVID-19, your health care professional has a complete picture of your health and health history and can help you make the best decisions for your care.