By: Kaitlyn Crobar
The basic idea of the Food and Drug Administration (the “FDA”) is to look at approval of food, drugs, medical devices, and other related things for safety and efficacy. Approved products should be safe for the consumer to use and not create their own risks. Drug manufacturers must determine the highest tolerable dose and the potential effects of the drug to ensure safe measures are employed by prescribers and consumers. Efficacy means that the medical product must produce a positive clinical benefit.
Typically for FDA approval the medical product manufacturers must take several steps. Drug approval requires pre-clinical steps, conducting pre-clinical studies, and conducting clinical trials in various phases which takes on average twelve years to complete. Medical devices must also undergo several pre-market tests and trials which take an average of three to seven years to complete. However, in times of crisis, like during the current COVID-19 epidemic, the FDA allows for Emergency Use Authorizations of both drugs and medical devices under the Food, Drug, and Cosmetic Act.
The Emergency Use Authorization process moves very fast. Authorization must first be granted from the supplier of a medical product for emergency use. Then an application can be submitted to the FDA for Emergency Use Authorization. Once the FDA gives authorization, the manufacturer can send the medical product to the physician who can then use the product with a patient. In the case of a drug, the patient must give informed consent before receiving the drug and the FDA must be notified of any adverse reactions. This process can occur all within the same day, making it much faster than the typical approval timeline for medical products.
There are two types of Emergency Use Authorizations. The first allows for medical professionals to use unapproved medical products to diagnose, treat, or prevent a disease in emergency situations. The second allows medical professionals to use an FDA approved medical product in an unapproved way. Either way before mass distribution the products granted Emergency Use Authorizations must undergo a fast-tracked safety and efficacy testing.
On March 28th, 2020 the drugs hydroxychloroquine sulfate and chloroquine phosphate were granted Emergency Use Authorizations for the treatment of COVID-19. These drugs are not new drugs, but old drugs that obtained FDA approval for other uses, placing them in the second category of Emergency Use Authorizations. Hydroxychloroquine sulfate has been approved to treat malaria, lupus, and rheumatoid arthritis. Some versions of chloroquine phosphate have been approved to treat malaria. Neither drug has been FDA approved to treat COVID-19.
The Emergency Use Authorization allows labs to test the effect of the drugs on COVID-19. Lab testing, often completed in the form of in vitro studies, has shown that the drugs help prevent the growth of the virus. With successful initial lab testing, clinical trials for hydroxychloroquine sulfate and chloroquine phosphate have begun. The clinical trials will take time to complete, although the process will be sped up. Doctors and researchers hope to have results in one year as opposed to twelve years.
Existing drugs that other nations have identified as potentially helpful in curing COVID-19 are favipiravir (a flu drug), remdesivir (a failed Ebola treatment), hydroxychloroquine with azithromycin (an antibiotic), convalescent plasma, and arthritis drugs. Tests are being performed on these drugs in countries like China, Japan, and France. We should not be surprised for the US to announce they have begun trials on these as well. However, the FDA has not yet provided any official Emergency Use Authorization for these drugs. As research continues, it is likely that Emergency Use Authorizations will be granted for new drugs created to combat COVID-19.
In addition to Emergency Use Authorizations for drugs, the FDA has granted Emergency Use Authorizations for new test kits, personal protective equipment, and ventilators. With the tests for COVID-19 taking several days to return results, many patients waited in worry. Additionally, the need for test kits far overgrew the supply available. This presented the need for more tests and for rapid tests so that patients could have same day results. The FDA has given over thirty Emergency Use Authorizations for both in vitro diagnostic products and molecular-based laboratory developed tests.
One new diagnostic test that was granted Emergency Use Authorization was created by the BD Company and BioGX Inc. Their test is run on a molecular diagnostic platform that is capable of analyzing hundreds of samples per day. This test is said to yield results in as little as three hours and is expected to increase the number of tests available nationwide by 50,000 per week. While their test has been given Emergency Use Authorization, it has not been approved by the FDA as a medical device to diagnose COVID-19. This means that the test can only be used to detect COVID-19 for as long as the FDA deems that there is an ongoing emergency.
As we continue to combat COVID-19, we will likely see the number of Emergency Use Authorizations rise rapidly. This is all in part of the dedicated medical professionals who are working tirelessly day in and day out to find solutions in order to end this epidemic.
Sources:
- Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#LDTs (last visited Apr. 9, 2020).
- Frequently Asked Questions on the Emergency Use Authorization (EUA) for Chloroquine Phosphate and Hydroxychloroquine Sulfate for Certain Hospitalized COVID-19 Patients, U.S. Food and Drug Administration, https://www.fda.gov/media/136784/download (last visited Apr. 9, 2020).
- Gail A. Van Norman, Drugs, Devices, and the FDA: Part 1: An Overview of Approval Process for Drugs, 1 JAAC: Basic to Translational Sci. 170, 170-179 (2016).
- Gail A. Van Norman, Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices, 1 JAAC: Basic to Translational Sci. 277, 277-287 (2016).
- Matthew Herper, When might experimental drugs to treat Covid-19 be ready? A forecast, STAT (Mar. 24, 2020) https://www.statnews.com/2020/03/24/when-might-experimental-drugs-to-treat-covid-19-be-ready-a-forecast/.
- Troy Kirkpatrick, BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in the U.S., BD (Apr. 3, 2020) https://www.bd.com/en-us/company/news-and-media/press-releases/bd-biogx-announce-fda-emergency-use-authorization–for-new-covid-19-diagnostics-for-use-in-us.