FDA approval may take time, which isn’t ideal in certain situations. For example, at the start of the COVID-19 outbreak, companies rushed to develop a safe and effective vaccine to protect the public from consequences of the virus. However, in order to respond to the urgent demand and need for a vaccine, these companies were allowed to release their products before FDA approval (in fact, some of these vaccines were only approved over one year after being administered to the public). The FDA provides Emergency Use Authorization (EUA) which allows unapproved devices to be used during public health emergencies, such as the COVID-19 pandemic (if you want to read more about this, I’ve added a link at the end of this post). I think that if companies can show preliminary data that there are no severe consequences to the use of their medical device/drug, then EUA is a great way to speed up the process of protecting the public during health emergencies and this authorization helped a lot with normalizing the effects of the COVID-19 pandemic. However, I know that a lot of people were unsure about the safety and efficacy of COVID-19 vaccines due to the lack of complete FDA approval. What are your thoughts on products that receive EUA from the FDA? Can medical devices also receive this authorization, and if so, can you give an example?
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#abouteuas - FDA Emergency Use Authorization
This really is a fascinating issue to talk about, AS we already know that the overall procedure for regular FDA Approvals takes time and years, whereas, In times of dire emergency where a device/procedure/drug needs to be made available to the common public, a EUA should only be approved, only after testing it on a control group, on a larger scaled compared to the control groups of FDA approval procedures. Results that cater to at least 85% percent of the population, and are proven to be beneficial, with the help of proper guidelines and awareness, the product should be administered.
I think there have been a few medical devices that have received EUAs, even during COVID. One example that I found was aimed at ventilator access as many hospitals found themselves not being able to support the volume of people that faced respiratory complications from the virus. In this EUA, the FDA authorized ventilators and ventilator accessories that were originally either not authorized due to not being in the market yet or had modifications that would require new 510k's to be used. This move helped hospitals provide better care for more individuals during the height of the pandemic when the healthcare industry faced many shortages.
In my search, I've come to find out that there have been many EUAs issued for medical devices, usually around disease outbreaks that we've heard in the news. Maybe it was because I was young and don't remember, or maybe ignorance, but I don't recall hearing about them. The first time I heard of EUAs was for the COVID vaccine. What circumstance or product that had EUAs issued surprised you?
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas - Ventilator EUA page
EUA is applied to strengthen public health protection against chemical, biological, radiological or nuclear threats by allowing to use medical countermeasures.
Although EUA approves devices/drugs/vaccines in less amount of time it never compromises the safety of approved product. The EUA for product only comes after they test major human population randomly and find least significant side effects. Although here they do not go into pathophysiology of each side effect and methods to alleviate and leave it to physician to test, prescribe and treat patients.
Products that obtain EUA approval allows usage of the product in times of dire emergency to the general public. In my opinion, approving medical products such as drugs and biologics with an EUA is tricky and high risk. Typically, the development and clinical trial period for drugs and vaccines is 10-15 years. Within this time period, researchers are capable of drawing observations on short-term and long-term effects. When an EUA is issued, the clinical trial period gets cut short and only short-term effects of the product are studied, which raise question to the long-term safety and efficacy of the product. For products where there's no variation in short- and long-term effects, an EUA is promising and constructive while an EUA for products such as drugs and biologics is risky.
The majority of the public respects the FDA's approval of drugs and vaccines due to their scientific standards towards their safety, effectiveness and quality. It often involves rigorous evaluation of all phases of clinical trials, but this can take a significant amount of time. However, in the case of public health emergency, such as COVID-19 outbreak, FDA approval cannot be feasibly achieved in such a short span of time. The priority in this situation is more to have something that is effective enough to help treat the ongoing health emergency, but this of course comes with the cost of not being able to take the time to test the long term effects of the product. Hence why an Emergency Use Authorization (EUA) was issued for the COVID-19 vaccines. Of course the public may have mistrust to EUA issued products since they aren't fully FDA approved. However, this does not mean that EUAs are not evaluated thoroughly. After an EUA request is submitted to the FDA, it is evaluated and determined "whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA" [FDA].
Personally, I did not have many second thoughts when getting the COVID-19 vaccine. I had heard about the symptoms afterwards but I felt that it was more of a priority to get vaccinated and gain some protection from the virus, which had higher risks associated with it at the time. Of course, I understand some people's hesitation, but I think it is important that people do their own educated research into what potential risks are and get trusted information from a health professionals. Especially during the pandemic, there was a lot of misinformation being circulated causing of course mistrust towards the vaccines and general pandemic.
This is a fantastic question, and it made me think of a couple devices that I have used in the past couple years that have had EUAs. The one I think I have used most frequently have been COVID19 tests. Most of the tests I have used are still under EUAs, with variable accuracy rates that I have simply accepted. While I would prefer to use a device with enough evidence for full approval by the FDA, having the option to be tested is preferred over no option. I would likely be more hesitant for a Class III drug or Drug / Device combination, as the risk for adverse effect would be higher.
List of FDA EUA diagnastic tests for COVID19: In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 | FDA
As of recent, the FDA using Emergency Use Authorizations (EUA) on drugs/vaccines has been on the fore-front of media for diseases such as Covid-19 and monkeypox. Lesser known is that the FDA can also use EUAs on medical devices and an example of a medical device that the FDA had approved an EUA for during the Covid-19 pandemic were non-surgical face mask. This Emergency Use Authorization was implemented in response to concerns relating to insufficient supply and availability of face masks. This is a great example of how something so minuscule and over looked as a medical device still needs to be approved by the FDA before entering the market. Similar to the vaccines, these masks that were given EUA by the FDA faced skepticism. Do you think the EUA label on any drug or even a simple medical devices causes skepticism by the public instantly? Why?
I think that the EUA is a great way to push forward critical use medical devices and applications to the general public in times of dire crisis and emergency. For a regulatory agency such as the FDA which takes great care and has extremely strict standards for approval of medical devices/drugs/vaccines to enact a program of EUA is a step in the right direction when we are in an emergent situation.
To answer the question from the poster above me, I think it does because of general lack of knowledge in the public as to how EUAs work. It can be a little frightening to hear that "The FDA just authorized a drug/vaccine under emergency use" and can lead some people to think that means the FDA did not do their due diligence in testing the efficacy of the product and ensuring its safety to the general public. From what I gathered online, the only difference between an EUA approval and a full FDA approval is just the amount of paperwork/administrative difference, nothing about the scientific rigor of the trials. One such example is for the COVID19 vaccine, for the EUA approval patients that participated in clinical trials only were followed for the two months after receiving the vaccine, and for the full FDA approval it is required that the patients be followed for at least six months.
I think one aspect that is important to note when discussing this topic is that although these vaccine companies were able to acquire EUAs, they still made the efforts of becoming FDA approved. The companies had sufficient preliminary data to suggest that they had effective treatments for the COVID19 vaccine. While the EUA allowed companies to begin distributing vaccines there were large amounts of the population that withheld from taking the vaccines due to the low amount of data that was provided about the vaccines. Following the FDA approval for the Pfizer vaccine, there was a massive spike in the public populations willing to receive the vaccine. Additionally, the EUA helped companies with gaining patients to be able to acquire further data and adjustments to dosages for the vaccines to find the ideal formulation for the public based upon demographic. Furthermore, as @sm2744 mentioned, there were ventilators amongst other devices such as infusion pumps, PPE, in vitro diagnostics, and respiratory assist devices that were all approved under EUA to help assist with the massive influx in hospitalizations of patients suffering from COVID19. When looking at the FDA website today, there is a whole page for Monkeypox device submission forms in preparation for EUA applications for these devices.
The FDA's responsibility is to guarantee that medical products adhere to exacting safety and efficacy standards. This process, known as "full approval," can take years. The FDA continues to maintain its strict standards even though that period of time is shortened when an EUA is granted. Since the pandemic began, the FDA has approved a large number of EUAs for COVID-19. It is less well known that the FDA can also use EUAs for medical devices. Non-surgical face masks are one example of a medical device for which the FDA had granted an EUA during the Covid-19 pandemic. This Emergency Use Authorization was put into place in response to worries about the availability and supply of face masks. This is an excellent illustration of how even a tiny, overlooked medical device still needs FDA approval before going on sale.
These masks, which received EUA from the FDA, faced resistance similar to that experienced by vaccines. Additionally, I didn't think twice about getting the COVID-19 vaccine.Of course symptoms are always a worry but I thought being, but there were more benefits than negatives to being immunized.
The FDA using EUA on drugs and vaccines during public crisis is rather controversial. The race for a vaccine during COVID-19 brought about companies using EUA to accommodate the public's need for a vaccine. However, the process of creating a vaccine was under close observation and it created public panic. I think this panic came about because the typical person is unaware of how a vaccine is created and how the scientific process is carried out. Vaccine development and other scientific developments are not exact processes as they are in current development. Failures are inherent during the development process. These failures can be in the protocol itself or revealed in data over a span of time. The COVID-19 vaccine efficacy was revealed quickly in the development, but its efficacy over time and health impact was questioned as it requires data over a significant timespan that would be out of the span of the COVID-19 pandemic. EUA on drugs and vaccines can have a positive impact on the public.