Food & Drug Administration (Safan Malik)
Fact Checked Source: Stephen M. Hahn, "Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19"
On March 30th, 2020, FDA commissioner Stephen M. Hahn made an update statement on the current event on how the FDA is working to expedite and support diagnostic testing in an effort to combat the coronavirus pandemic.Looking Deeper: Five Facts Checked
In order to better understand the claims made in this op-ed, I've done research to verify five facts it presents about the coronavirus pandemic.I wanted to look this claim up because the FDA's primary role is very important when discussing their updates and intentions to the public. As it turns out, research from EDinformatics confirms this.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.
This fact is very interesting as it is one of the more powerful and unique tools that would set the FDA apart as an integral stakeholder in the wake of the pandemic. According to the National Center for Biotechnology Information, this fact is true.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.
This fact matters not only to current circumstances but all circumstances in which the FDA is making a difference towards safety through commercial support. According to the Wall Street Journal, this fact is true.Claim 3: The FDA supports laboratories and commercial companies to expedite the development of new test and diagnostics, to address the COVID-19 pandemic
According to the National Library of Medicine, the FDA can and does updates it's policies in certain circumstances, but its strict guidelines makes this occurrence not very common.Claim 4: The FDA updates its policies to accommodate for urgency in for faster testing, and medical availability
This may not be expected, however, according to the CNBC, the FDA usually does not sacrifice safety for urgency and quantity, even in the midst of a crisis, with only a few instances of exception due to social pressure or updates guidelines, and will only give the green light when many trial testings have proven safe and useful.Claim 5: The FDA will accommodate, but will not sacrifice safety for urgency and quantity for new medical diagnostic and health tools, when quality and strict guidelines lead to safer conditions
Analytic Essay
In Support of Safety: The FDA's Perspective on COVID-19
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.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 incentivised 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.
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 such as revising the process to allow labs to begin testing prior to FDA review of their validation data and implementing changes to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review. 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.“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, 2020).”
The FDA also has a unique tool to utilize in the midst of an urgent issue. The Emergency Use Authorization (EUA).
Two big examples of this is the EUA put on the use of convalescent plasma to treat critically ill patients and the EUA on the testing of a drug known as hydroxychloroquine, which is used for malaria and lupus victims. 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.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, ).”
The convalescent plasma is from patients who have recovered from COVID-19 and have formed antibodies against the disease in their blood plasma. The FDA has made guidelines to follow under this condition but has authorized the emergency use of this plasma.“shortages have been reported, depriving some people with autoimmune disorders such as lupus who also depend on hydroxychloroquine (Piller).”
The FDA has stated that in these cases a doctor can phone or submit a form online, and in 4 to 8 hours, receive verbal approval for the emergency treatment. This has allowed for not only promising emergency treatment, but also opened up research into the plasma to develop drugs and diagnostic tools to help better treat victims of the coronavirus."The plasma must be collected from recovered patients who can donate blood, have had no symptoms for 14 days, and have had negative results on covid-19 tests... providing emergency access to convalescent plasma for patients 'with serious or immediately life threatening covid-19 infections(Tanne, 2020).'"
References
Stephen Hahn. (2020 March 30). Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-diagnostic-tests-combat-covid-19This source is from the official government website of the FDA. This sources perspective is through the main perspective of the FDA, being as it was written by a commissioner of the FDA and is on the official government website. This source's purpose is to relay information regarding the FDA's abilities to help people suffering because of the corona virus, and expedite diagnostic testing for covid-19. This source also provides information of what the FDA is trying to look for improving in terms of its policy updates, its testing policies, and authority in the healthcare system. This source provides a crucial perspective from the FDA stakeholder and what it hopes to achieve during the corona virus outbreak.
Jianlin Song. (2020 March 23). FDA's Role in Battling the COVID-19 Pandemic: Part I What Manufacturers, Diagnostic Laboratories and Their Insurers Need to Know. The National Law Review. Retrived from https://www.natlawreview.com/article/fda-s-role-battling-covid-19-pandemic-part-i-what-manufacturers-diagnostic
This source is from a news report site National Law Review. This perspective is from a news analyst, providing information on what role the FDA plays in the "war" against the corona virus. The perspective seems skewed towards the FDA, as there is no negative outlook towards the FDA, and only positive notes. However, most of the information is factual and provides answers to its target audience, which is people that want to know what FDA is doing specifically to help against the corona virus pandemic. The main purpose is to provide information about what roles the FDA plays specifically in fighting against the corona pandemic, and how it relates to other efforts to keep american citizens safe. This source is filled with the primary role info if the FDA, and can be used as a basis for comparing the events happening right now with the FDA.
David Heath, Nick Penzenstadler. (2020 March 31). FDA shut down at-home coronavirus tests, but will they be part of the solution? USA Today. Retrieved from https://www.usatoday.com/story/news/investigations/2020/03/31/home-coronavirus-test-fda-shut-them-down-but-they-solution/5080703002/
This source is from USAtoday, which is a well known news source for US citizens. It shows the perspective on testing for the corona virus, and how the FDA has addressed testing and its controversies. The source has perspectives from companies that sell testing kit devices and administer them, as well as what medical professional say about the FDA and its decision to shut down at home testing. The purpose of this source is to understand why the FDA is hesitant on letting companies distribute at home testing, what the benefits and consequences are, and how the FDA plans to handle testing in general with healthcare. This will show the perspective of company perspectives on the FDA, and whether the decisions are to help keep the people safe and help health care systems, or be a result of poor decision making based on the unknown.
Janice H.Tanne. (2020). Covid-19: FDA approves use of convalescent plasma to treat critically ill patients. The Biomedical Journal.
This is a scholarly source by the Biomedical Journal. The author of this source has affiliations with New York press and makes many articles highlighting the advancements in health care provision to help patients suffering from covid-19, and deepen understanding of medical procedures and tools used to treat and cure patients. The author uses information directly from the FDA and also utilize statistics from previous cases such as influenza to compare the use of the treatment. This source will show a deep perspective of a crucial part of the FDA in approving the use if blood plasma to treat patients, and make large difference in the treatment, and eventual vaccine for the corona virus if the authorization is used and done carefully.On March 30th, 2020, Stephen M. Hahn released a FDA statement update, highlighting the support the FDA is providing in diagnostic testing for relief against COVID-19.