FDA Perspective Page (Safan Malik)
The FDA, known as the Food and Drug Administration, is a federal agency of the Department of Health and Human services. This government facility was incorporated with the main purpose of “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices”, as stated from the official FDA government website. It is to no surprise that the FDA plays a crucial role within the current coronavirus pandemic sweeping the nation. The FDA’s responsibilities tie close with the healthcare system, focusing its efforts on making sure diagnostic tests, devices, and guidelines are safe and accurate, to ensure the safety of the people and healthcare workers risking their lives to treat patients that have become victims to COVID-19.Claim 1: The FDA's primary goal is to determine whether tests produced by healthcare facilities are accurate and reliable. Not to develop them, but to be tested for effectiveness and accuracy.
Claim 2: The FDA makes use of its Emergency Use Authorization (EUA), which allows for quicker available authorization based on less information, and speeds up help in crisis.
Claim 3: The FDA supports laboratories and commercial companies to expedite the development of new test and diagnostics, to address the COVID-19 pandemic
Claim 4: The FDA updates its policies to accommodate for urgency in for faster testing, and medical availability
Claim 5: The FDA will accommodate, but will not sacrifice urgency and quantity for new medical diagnostic and health tools, when quality and strict guidelines lead to safer conditions
What most common citizens are unaware of, is that the FDA can authorize and support companies and laboratories and allow them to produce FDA approved tools for use in the event of a crisis. This allows for faster and more incentivized efficiency in the event these medical tools, drugs, and guidelines are needed. On March 30th, 2019, the FDA made a statement to the general public on their official government website (where they communicate almost all of their statements, updates, and news) about expediting the review of diagnostic tests for COVID-19, and ensuring their priority to help combat against the current issue. The FDA is using its supporting abilities and authorization, to make it easier for companies and labs to make more diagnostic tools. Unfortunately, these companies and labs are strictly based upon the FDA’s trusted choices. Only a few will actually obtain support from the FDA. Expediting has been helpful, but there is a still a lack of testing in the nation, most of them having low reliability. On March 31st, the FDA shutdown the sales of at-home coronavirus testing kits due to it unreliability and cause ‘fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment’, made in a statement by the FDA. (Heath, Penzenstadler). These at-home test kits could help combat against lack of testing and resources, but the FDA is not willing to sacrifice safety and quality for quantity on potentially false devices. As stated by the FDA, “It’s critical that the tests used work. False results can also contribute to the spread of COVID-19. We want our treatments to be tested for effectiveness and reviewed by the FDA. We want the same for our tests—assurances that they are accurate and effective (Hahn).” The perspective of the FDA is tightly regulated for safety; however, the FDA has shown a little more leniency in their policies. The FDA has made updates to their policy to allow for faster testing availability in an urgent crisis, stating “the FDA revised the process to allow labs to begin testing prior to FDA review of their validation data” and “[implementing] another change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review (FDA).” These updates to policy and leniency with review will allow other companies and laboratories to review and develop diagnostic tools quicker which will provide more relief to many healthcare systems.
The FDA also has a unique tool to utilize in the midst of an urgent issue. The Emergency Use Authorization (EUA). The EUA is “a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review (FDA).” One big example of this is the EUA put on a drug used to treat malaria, that is also being tested to see if the drug will be effective on the corona virus. This drug is known as hydroxychloroquine, which is used for malaria and lupus victims. President trump has since endorsed this EUA. If the drug proves useful against COVID-19, the authorization will allow for faster confirmation and mass distribution. However, mainstream media and misinformation has led to the belief that the drug has already been confirmed to cure COVID-19 and the president has made emphasis and implementing the drug immediately for use without proper testing. This led to “shortages [having] been reported, depriving some people with autoimmune disorders such as lupus who also depend on hydroxychloroquine (Piller).” The FDA cites that the EUA is done under ‘limited in-vitro and anecdotal clinical data in case series.’ The FDA’s intentions are not to harm the public or allow for immediate use, but to help make reliable testing, and diagnostic and drug testing faster. To get to the healthcare systems and patients that need it.