There is much confusion about which medical products can work to prevent or treat COVID-19 disease. Although scientists are working hard to develop potential drugs for the prevention or treatment of coronavirus, none have yet been approved by the Food and Drug Administration (FDA).
There are some drugs for these purposes that are in the clinical trial phase. In some cases, scientists are conducting tests to see if drugs that have been approved for another disease are safe and effective against COVID-19.
As studies continue under the FDA’s Expanded Access Program, or under an Urgent Use Authorization, these drugs are made available to patients, still not approved as a treatment for COVID-19.
Healthcare providers may also decide to treat a patient with a drug that has been approved by the FDA for a specific use, but not for the patient’s disease or condition.
If you think you have or have had COVID-19, your healthcare provider has an understanding of your complete health, as well as your health history, and can help you make the best decisions for your care.
Meaning of FDA approved
During this public health emergency, there is an urgent need for products to treat or prevent the virus that causes COVID-19.
Before the FDA can approve a drug, the agency must determine whether clinical data and other information shows that the drug is safe and effective for its intended use and that the product can be manufactured according to federal quality standards.
When the FDA approves a drug, this means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh the risks when used according to the approved product label.
The FDA is working with manufacturers and researchers to make sure the agency is receiving the information necessary to complete the evaluation of drugs to treat or prevent COVID-19 as quickly as possible.
According to the FDA, a investigational drug it can also be called an experimental drug. Scientists conduct clinical trials to study investigational drugs to see if they can prevent or treat a specific disease or condition. As part of those clinical studies, they may try to find out:
- How the drug might be used for that disease or condition.
- If the drug is safe for humans.
- How much of the medicine is needed.
- Information about whether it works to treat the disease, and the possible benefits and risks of taking the drug.
According to the FDA, the extended access is a potential avenue for a patient with a life-threatening illness or condition or serious get access to a investigational medical product as a treatment outside of clinical trials when there is no alternative therapy that is comparable or satisfactory.
At the moment, expanded access is an avenue for the use of the COVID-19 convalescent plasma in patients with the severe or life-threatening illness of COVID-19 who are ineligible or unable to participate in randomized clinical trials.
There is limited information to suggest that convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the virus and can help COVID-19 patients. Since the current information available is limited, it is important to evaluate this therapy in the context of a clinical study.
Urgent Use Authorization
According to the FDA, an Urgent Use Authorization (EUA) is one of several tools that the FDA is using to rapidly provide certain medical products during the COVID-19 pandemic.
During certain emergencies, the FDA may issue an EUA to offer access to potentially usable medical products when no other suitable, approved or available options are available.
The process for obtaining a US authorization is different from the approval or validation process. Under a US authorization and during an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that is needed to obtain FDA approval or validation.
When evaluating a US authorization, we carefully balance the potential risks and benefits of products based on currently available data.
EUAs are effective until the emergency declaration is complete. EUAs may also be modified or revoked by the FDA at any time while the available data and patient needs continue to be assessed during the public health emergency.
Once the FDA has approved a drug for a disease or medical condition, health care providers generally can prescribe or administer the drug in clinical practice for unapproved use that is not included on the approved label (“no indicated on the label ”) based on their clinical judgment and acknowledging that the FDA has not evaluated the safety or efficacy of such use.