I do agree that the FDA is strict to an almost oppressive extent, but given the types of products they are dealing with, it makes sense. The rigorous and lengthy process of releasing a new product to the public ensures that it is for the right reasons and not just to fool people and make a quick buck. People can't just give you something they cooked up in a garage that contains components which could seriously harm or even kill you if used. Extensive trials need to be conducted which prove this product will do exactly as intended and not have any serious side effects. This requires time and money, but that is the cost of possible saving hundreds and thousands of lives, if that is the application. Even working for a medical device company and seeing some of the hoops you need to jump through during this process, I understand it and realize it is easier to just comply with them than try to fight it. If something were going to be used inside me body to augment function or even keep me alive, I would want it to have been properly vetted. Even through all this regulation we still see products recalled anyway, so some mistakes make it through the cracks regardless.
The FDA has to be very strict to protect public health by regulations to oversee food, drugs, cosmetics and medical devices. It is true that lenient FDA regulations could increase innovation in technologies to create improved drugs and medical devices however that does not guarantee the proof of safety from extensive research and clinical trials. With the currently FDA regulations, a prescription drug approval requires companies to prove its safety and efficiency with years of research and clinical trial data. FDA takes the responsibility to regulate an industry, protecting consumers from potential health risk. Without strict regulations FDA might not be able to effectively protect consumers.
I understand why some people see that the FDA is too strict because it's slowing down the release of the product. However,I believe that this is the way it should be to ensure the good quality of the products that are launched in market.I also understand why some of my classmates believes that the FDA regulations hinders the ability to innovate.However, FDA regulations allow products to only be released only after ensuring the safety and efficacy of it. In addition, if people see that the process is long, but it puts people’s lives at less of a risk from being harmed by the product. As annoying and strict as the FDA may seem, it is actually helping to improve people’s lives by only releasing products that they feel will have the best results.
In this discussion, we can refer back to our last discussion regarding the challenges in the medical devices industry, in which most replies stated that FDA approval and regulations are the most challenging step in developing a new medical device or medical drug. I wouldn't agree with saying that FDA is too tough and strict. Going over their statement which shows and researching more about the regulation and approval steps can tell that it is not an easy and fast process. As it is linked to human life and public health safety, one should expect the highest level of ensuring security, safety, and effectiveness of a new treatment or new medical device which would involve a long process of clinical trials and lab tests.
On their website, FDA clarified their drug development designations system as there is a "Fast Track" which is related to treating serious conditions (life-threatening) that need a quick and early drug approval. The next one was the "Breakthrough Therapy" designation that is responsible for reviewing drugs that cure serious conditions which in particular may have a worthy advancement over a ready-to-use treatment (which is clinically significant). The third designation is the "Priority Review", that is will direct the all resources of the drug to the evaluation step. This would work in case the drug has a high possibility that if it was approved quickly it will significantly improve diagnosing or preventing serious conditions when unlike normally available solutions and applications. However, the quality of testing and approving a drug or medical device would not be altered in any case. Speeding FDA approval process would certainly solve the problem of the new pharmaceuticals development delays and the decline in the past year.
I don't think the FDA is being too strict. With anything that is new, there has to be accountability. The regulations that are put in place, forces companies to be ethically sound when proposing new technology that can have negative impacts on the lives of people if corners are cut. No impact should be considered small enough to warrant a lack of due diligence on both the company proposing the device and the FDA in regulating it. We often step back from situations if it does not directly pertain to us or someone we know. How would you feel if one of your loved ones were negatively impacted due to a device getting cleared by the FDA under a less strict regulation procedure?
I believe that the FDA would rather over-regulate than under-regulate. It's not always a bad thing though. The products that would affect someone over their entire lifetime need to be carefully considered when deciding whether or not they should be put on the market. One big issue for me is when a product could be used on someone who is terminally ill. I believe that people should be able to test certain potentially life saving/extending products if they choose to. As long as they are made aware of the products facts (i.e. potential side effects or whether there is a lack of knowledge of what may happen), they should be able to use them. You may say that this would be taking advantage of them, but those who have no other options deserve to choose whether or not they want to be a part of a "hail mary" option. One that may actually work. Everyone deserves a little hope. There are some "right to try" laws but they could be better.
I recently read an article that was published in 2015, that discussed if the FDA was being to strict and the consequences from it. The article argues that the FDA is strict because there are more severe consequences from approving a bad drug than failing to approve a good drug. It’s difficult to take a side here because if the FDA was not strict and approved most drugs, they risk a lot of people getting sick or dying. The other issue is that the FDA being too strict really does limit the opportunity of putting out drugs that may be successful in helping people. The article also states that failing to approve a good drug is more costly. And by costly in terms of the possibility of treating a severe disease.
Maybe what the FDA could consider is the severity of the disease the drug will treat. Will the person die with or without the drug? If they will, maybe the process for drugs that will be used for severe diseases should be less conservative.
Determining how restricted a certain medical device or drug should be in order to effectively protect consumers is certainly a difficult and somewhat abstract task. Assessing the risks and possible side effects requires a tremendous amount of effort and even then, there is almost never a 100% certainty that those observations are accurate. Therefore, when we acknowledge the restrictions and guidelines the FDA imposes on companies for these products, it is important to understand that it is better safe than sorry. It would obviously be counter-intuitive to produce a product that resulted in harming consumers that intend to improve the quality of their lives so to ensure the prevention of that is more helpful than not. Of course without such strict requirements, we may have an increase in the development of innovative medical technology, but it will come at a cost to great to justify. In addition, it is important to note that the medical device industry is, well, and industry. It consists of multiple competitive companies, all working to provide the best products as quickly as possible. This, as a result, often leads to a disregard for quality and safety which would otherwise be a severe issue without the enforcement the FDA imposes.
I agree with the above comments that it is better to over-regulate than under-regulate. If there were to be medical devices on the market that were hazardous to humans, like those remedial cures in the early 1900's, then there would be a lot more harm than good. Also, the way the legal system works now, there would be lawsuit after lawsuit for injury claims from these devices. There has to be strict regulation for the things that are put into our bodies. I am sure that there are some fields that need fewer regulations than others, but from my experience in the medical device field, I know that documentation can get really sloppy. We would rather leave the harder work for others than do it ourselves, but there eventually needs to be somebody who looks over our shoulder and corrects us when necessary, and that is the joc of the FDA.
I do agree that the FDA rules are strict, and it delays the release of some products that can change the world. But I said some products because there are products that can harm instead of helping which makes the strict rules very important. The FDA should preform new tests that will be able to test the accuracy and precision faster because some people need the product now, some don’t have enough time. Faster test that are accuracy and precise can help speed up the process, if the product work they’ll be able to distribute it, if not they can work on another idea, they will not have to wait for years to find out of the answer.
Yes the FDA is too strict, but when it comes to regulating a devise that affects a human and their life, the FDA needs to be really strict. This causes them to be slow, really slow. But I don't think that's bad. It's better to be slow and sure than to be fast and allow a chance of failure (which could potentially cause death). I understand the argument that FDA's rigid applications and regulating procedures might drastically slow down future innovations, but in this day and age, there are usually many substitutes to keep the patient under treatment until those future innovations are justified. If the innovation is completely novel and could save lives like no other device, there is the Humanitarian Device exemption (HDE) under the FDA that allows these kind of devices to be used in 4000 or less patients. Due to these reasons I think it is good that the FDA is strict and should continue being so for the health and safety of the public.
I don't work directly with process involve working with FDA, But I've heard how long it takes for FDA to process. One of the most concern when we work with project required FDA approval for part replacement, the company will try to avoid because of testing and requalification could take months if not a year. But, on the other hand, FDA tries to secure human health and make sure it is okay to roll out the product. However, we still see mistakes and failure and recalls, So we can imagine if FDA is leaner, we will face more of these problems I think. In my opinion, FDA should be faster either but having more resources dedicated to working on a project or utilizing tools to make processes faster, but not changing the rules. We need an organization such as FDA because some companies only care about revenue with exceptions to work ethics and that when we appreciate FDA regulations.
Working in the pharmaceutical industry, I do not feel that FDA regulations are too strict. When it comes to products that have a direct impact on our life, whether it be through food or drugs, this administration needs to make sure that whatever it approves is completely safe for humans. Sure, sometimes that philosophy may keep some products away from the public from a little longer, but if they do not then more lives are put at risk. The process may be slow, but it is thorough.
I personally feel that the FDA’s strict rules are essential when it comes to new devices or products in order to protect the public from the possible bad outcome. It is their central goal to protect the public health and safety. The FDA was organized by the U.S. as the regulatory department for all human drugs, animal drugs, medical devices, equipment that emits radiation, face, and body cosmetics, and last but not the least food. Due to these strict rules, they tend to have a long and detailed process that needs to be followed in order to get a device or a drug out in the market. It has its own few benefits, it verifies multiple times with their own various clinical trials until the results are safe and no harm to a human being when used.
Part of FDA's mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are "advancing the public health by helping to speed innovations that make medicines more effective". Do you think the FDA is too rigid and tough to the point where they might be slowing down the process of the product and possibly restricting future innovations? The FDA are doing their job to keep us safe but is it going too far by being too strict? Is there a middle ground with the government intervention in the industry?
In my experience, the FDA is actually one of the more lenient regulatory bodies in the medical device fields. BSI is Europe's regulatory body, and the submission process is much more complicated that the 510(k) submission process. BSI requires you to document much more and have your design/risk documents to be in a much more mature, finalized state than the FDA does. Countries like China and Japan have even more strict submission requirements. Additionally, even with all the documentation required to receive 510(k) clearance, there are still misses and products are required to be recalled. So, even though the process is long and there are many requirements that need to be satisfied to receive 510(k) clearance, they are necessary requirements and are actually not as strict as other countries regulatory bodies.
