FDA rules and regulations can be frustrating. But because they are strict, it has been being possible to release the drugs in the market successfully. The job of FDA ensures the safety and quality of a product before it is used on patients. A little difference in the product can put patients at risk. Therefore, it is important to overrule in some cases when it comes to releasing these products for the first time. If FDA was not that strict, many companies would have come up with shortcut ways of their research and release method which could possibly be risky for patient use.
As my work is currently in the process of getting a medical device FDA approved, I understand where the frustration comes from with how strict and lengthy the FDA process is. However, I do not think that the FDA rules and regulations are too strict. The reason the process has become as strict and as lengthy as they are now, is from misfortunes that have occurred from having a process that was too lax in the past. The FDA has the responsibility of making sure the drugs and devices being released to market are safe for the public to use. Without stringent regulations, these drugs and devices have the probability to not only cause injury or harm but also death or other life-threatening consequences.
We agree that the FDA regulation saves lives by ensuring the safety and efficacy of the medical device. However, it still slows down the process of commercializing the medical device. Aside from having strict rules to approve the medical device, biologic, or drug, the process from applying for the new device to getting the device inspected is time-consuming. After submitting the required application for the medical device, it takes months for the FDA to review the papers and schedule an inspection date. These delays may cause a delay in the project schedule to get the product commercialized. having delays in commercializing the product
can cause an increase in the cost of the product.
Although the precautions taken by the FDA seem to be too many, it is not too much because it is about human health. In a place like America where different nations live together, there should be very strict hygiene and health rules. Every country has very different health controls and rules. If there is no strict control in America, human health is in danger. That's why I find the precautions taken by the FDA to be appropriate and correct. In this way, not every drug enters the market immediately and human health is not endangered.
While I do think the FDA is very strict, the drugs and devices that they are regulating affect millions of people. That being said, without regulations and strict rules, some of these devices could be harming more individuals then they are helping. At Getinge, also known as Maquet, I was able to partake in a FDA audit when I first started working there. The FDA auditors seem to be very thorough and presented us with observations and findings that we would work through to better our processes and correct some of the errors that we had in our documentation. I have also been able to be a part of 510K submission which is also very interesting. While it may seem like a lot of work, and there is a lot of justification and testing involved, it is obvious that it is being done so a majority of the problems in the product are brought to light before it is released. It may seem like the FDA is to hard on companies and demands perfection, but it is only so consumers of the products can use them and have less worry that they are unsafe.
Hi Sahitya,
No, I do not believe that the FDA approval process is too strict. I do think that there is a middle ground involving treatments for diseases that are currently lacking options. If the illness is one that is causing increased mortality, there should be a more effective way to ensure safety in order to get these products to the market faster.
I do not think the FDA approval process is too strict. I think there's tedious process to go through because of how important it is to make these products safe. The FDA has come a long way since its beginning, becoming more and more strict with their protocols, which I think is a move in the right direction. I do not condone the approval process being so strict that it is nearly impossible to be approved though. That wouldn't be helping anyone on either side.
I do not believe the FDA approval process is too strict. I can see why one would think this, as the process is very long and drawn out. In my opinion it must be this way as we need to keep all food and medicines we consume safe to everyone who needs them. Although I do believe we need to find a way to get things to the market faster, keeping people safe should always be the number one priority.
It's interesting that some people find that the FDA rules are too strict because I often believe they aren't strict enough. So often and consumers see the scandals of drugs or devices being taken off of the market due to something at the FDA found not being up to standard. This leads me to think that the FDA could do more to catch some of these problems before they went to market the first place. I don't think that FDA has the manpower to address to make the process more streamlined and efficient for companies to get their products through. There seems to be a lack of people interested in pursuing regulatory affairs as a long-term career within the FDA. This possibly may be due to the FDA being a government job with less opportunity to make money when compared to flashy industry companies. It can be argued that if the FDA had more high-value people working within its ranks the process could be more effective and streamlined.
To prevent patients from risky medications or devices, the effectiveness and safety are regulated by the FDA.
The FDA's lengthy approval procedure is its means of protecting the general public's health.
The FDA loosening the rules will speed up the approval process, allowing the medications to reach the market more quickly.
However, lowering the standards already in place for medication approval may allow more drugs that are less effective or even unsafe to reach the market.
To prevent patients from risky medications or devices, the effectiveness and safety are regulated by the FDA. The FDA's lengthy approval procedure is its means of protecting the general public's health. The FDA loosening the rules will speed up the approval process, allowing the medications to reach the market more quickly. However, lowering the standards already in place for medication approval may allow more drugs that are less effective or even unsafe to reach the market.
@jordankayal It's very interesting you brought this up. It's the FDA's job to review, approve, and regulate pharmaceutical drugs, medical devices, and medical products. The overall goal is to make sure a product is safe for use. One would question whether the FDA always gets it right. I agree that other countries, like Japan, as you mention, have a stricter govern body than the US. As a consumer, when you hear of a drug, device, or product being recalled or taken off the market, I wonder how it got approved if it's not performing how it should. One can assume there is an underline issue of trust between the FDA and the public especially knowing that the commissioner is appointed by the president and approved by the senate. The FDA is not exempt from pressure from political parties and big pharma companies.
I agree that strict regulations of the FDA truly slow down the time product procedure, but it is what the FDA's role is. FDA regulation ensures the device or drug the public uses is as safe. I know the FDA's slow regulation would delay the time of the product to the market, which would reduce the company's profit. But I don't think this would block the innovation idea. Because it is an innovative idea, the statement must receive more examination. If there comes an emergency, there is still Emergency Use Authorization (EUA) in FDA, even though it is controversial sometimes. I also agree that the time and cost of waiting for approval are a little too much. Most little companies don't have enough funds for this lengthy procedure. Most of them can only choose to cooperate with more prominent companies.
In 2019, an article was published stating that FDA regulations are barring millions from life-saving drug access. Still, though it's strict and a very lengthy process, I think it's necessary. Proper screening before approval is needed to ensure safety. And yes, I also wanted to give the example of Thalidomide as others.
