Drug review times at the FDA have been shown to be significantly shorter than that of the European Medicines Agency (EMA), with the median times of initial review being 303 days, compared to 366 days at the EMA. Although the approval process may seem very slow, it isn't in comparison to the regulatory agencies in other countries. This makes sense, since every country should prioritize safety over speed. However, it may be a problem when the lack of innovation ends up costing a lot of lives. Therefore, the FDA should focus on efficiency rather than speed and priority should be given to devices which treat more urgent health issues. Another point to mention is that it seems the fees per NDA at the FDA is much higher than that of any other country, which could be a barrier for innovation, especially for smaller companies.
Reference:
https://www.sciencedirect.com/science/article/pii/S2452302X16300638
During this MDD course is the first I was made aware of what the FDA's mission statement is. I actually giggled out loud at the second portion which claims they are "advancing the public health by helping to speed innovations that make medicines more effective." This was my initial reaction because it is known that most application processes through the FDA can take from months to years, and how could something that takes so long actually be speeding up innovations?
Well, it only took a few seconds of thought on the alternative to realize that is exactly what they are doing. A famous example in regard to the absence of a regulatory agency is the Thalidomide tragedy on the European market back in the 1960's where a sleeping pill was released without being adequately tested, claimed to be safe for pregnant women, and then had detrimental effects on the children born with shortening or absence of limbs. Therefore, yes, going through the FDA takes time, effort, and of course money to prove that the product under review is safe and efficient for its intended use. However, if the FDA did not make this strenuous route required for devices and biologics as necessary, hundreds to thousands of human lives could be at cost. The FDA has such processes in place to protect the public from harmful, untested products with unproven claims being put on the market for consumers.
Reference: https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation
The FDA approval process is known to be very slow and this would beg the question if FDA regulations are overly strict. Personally, I agree that the FDA regulations are too strict. The FDA is meant to protect and ensure the safety of Americans who are consuming foods, taking medications, and receiving medical treatments (and etc.). Therefore, it is nice to know that there are rigorous regulations that in the end would help the consumer. Although I think the process does take a little long, I think it is for the best in the end. Moreover, in emergency situations, like we are in right now with coronavirus, or even for more serious conditions, the FDA provides expedited approval processes and programs. In the end, the FDA sets regulations for the safety of the people, and thus, I am glad to know that these regulations are strict.
It could take up to 14 years or more in order to develop a new drug and have it approved by the FDA. While this may be an extremely long process, it is necessary to avoid having companies take advantage of people in desperate need, all for the money. We have to keep in mind that the lives of people lie in the hands of these companies. Many people can come up with a drug for cancer, but how many people actually get approved for that drug? What if that drug worsens the situation? The FDA ensures that every single compound or material going into a human/animals body is effective and safe at all means. Years ago, thalidomide was approved by many countries for avoiding morning sickness in pregnant women. Because of the lack of strict regulations in these countries, the babies were born with series birth defects. The FDA in the USA did not approve of this drug and prevented many birth defects from happening. The FDA uses the thalidomide issue as an example of why it is necessary to have strict regulations. It is better to wait years to have an effective and safe drug on the market, then to have a drug that is not safe in a few years, and be sold to many innocent people.
I do not yet know a lot about all of the restrictions that the FDA has put forth, but based on the initial post, it does not seem that the restrictions are too stringent. As stated in the first post, the second part of the FDA's statement wants to speed innovations that make medicines more effective. If they are in fact "speeding innovations" I am not quite sure how this could result in a process that in effect becomes slower. It seems that it would completely conflict with their goal. I also think that the FDA has to be strict in its policies. If they were to become lax then that will directly impact the health of the people the FDA is in place to protect.
I do not think the FDA is being too strict in their regulations. Their goal is to keep the general public safe from any harm from drugs, medical devices, and food. If they weren't as strict as they are, some companies who develop the products listed above would take certain leeways for a cheaper production cost at the expense of the consumer. Slightly off-topic of medical devices, the lack of regulation in the beef industry on child labor laws and meat quality meant that the meat being sold did not have to meet any regulation standards of quality. This lead to human body parts being found in beef being sold to the public and many health issues during the Great Depression. These same instances could happen with loosened regulations with medical devices and drugs being sold to the public. The FDA is strict, but there are instances where amendments are put in place to modernize their regulations and allows more room for innovation. If I had to choose between the general public's safety or the innovation of medical devices, I would sacrifice innovation to make sure patients aren't getting a shoddy product.
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?
I think that the FDA is one reason the US is currently a leader in the drug and medical device industry. Not many other countries have said regulatory authorities, and they have a saturated market with things that may or may not even work. I do not think that the FDA regulations are too strict, but I believe that getting something FDA approved could be more streamlined and efficient. If the process was just rigorous but quicker, then I think we would see an influx of the amount of innovation taking place and an influx of quality products.
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?
I think that the FDA is one reason the US is currently a leader in the drug and medical device industry. Not many other countries have said regulatory authorities, and they have a saturated market with things that may or may not even work. I do not think that the FDA regulations are too strict, but I believe that getting something FDA approved could be more streamlined and efficient. If the process was just rigorous but quicker, then I think we would see an influx of the amount of innovation taking place and an influx of quality products.
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?
I do not believe that the FDA is to rigid and tough as they are doing what needs to done to ensure that a quality and effective product is being brought to the marketplace. I do not believe that they are slowing down the process because devices need to go down a certain process to ensure the precision of it as well as the accuracy. I do believe that FDA are doing their job to keep us safe and certain measures have to be set into place to make sure that this happens. Many can see it as strict but in the long run it will make sure certain complications that can be prevented are prevented.
This is a really great question. I do not think that the FDA's rules and regulations are too strict. Even though their mission statement is two prong wanting to ensure patient safety while advocating for innovation, the rules and regulations should protect the needs of public health foremost and this protection must be accompanied by strict rules and regulations. However, I do not believe that this comes at a cost of innovation. It can be argued that this actually increases innovation for researchers to develop safe and effective products while pushing the market forward. This coupled the the 2018 mandate that Class II devices cannot have a predicate older that 10 years should speed up innovation rather than halt it.
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?
I do believe that the FDA is being to strict and tough with some of the regulations they have in place but a the same times there are things that have happened in the medical history that called for the FDA to put those regulations in places. Yes, these regulation had probably put us hundred of years behind where we could be in the medical field but it has probably also saved millions of lives in the process.
Similar to the previous posts, I can understand why some might think that the FDA regulations are too strict. However, the regulations enforced by the FDA are arguably not as strict as those enforced by the regulatory bodies in some other countries such as Russia and China. Similarly, in the EU regulations are changing from the Medical Device Directives to the Medical Device Regulations (EU MDR). As such, EU regulations are becoming increasingly more strict. When the regulations in these countries are compared to the regulations enforced by the FDA, the FDA does not seem nearly as tough and rigid. I am wondering if anyone is familiar with MoH's around the world? In these stricter countries such as Russia and China, do you think these regulations are too tough and rigid? Do you think these countries would be open to international regulatory harmonization if their requirements are much stricter than other countries around the world?
I think that the FDA is being strict with their restrictions which is absolutely necessary to ensure that all innovations do not harm the population. The medical industry is mainly based on profit, so if the FDA loosens up its restrictions then companies would come up with innovations that will not be entirely effective to its patients solely for the purpose of getting their sales up and making more profit. If the FDA were responsible for devices that don’t affect the human health, then it would make sense to loosen up the restrictions. The restrictions do more benefit to the population than harm. However, I believe that there is always room for improvement. This can be done by keeping the strict restrictions, but making the process more user-friendly to make it easier for companies to release their products into the market.
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?
I think that there is a fine line between innovation and safety and the FDA is the responsible party for both. From a company perspective, the FDA (and regulation, in general) is looked at as the bad guy since it impedes the ability to quickly commercialize and take a product to market. However, whenever a product goes awry and faults are found, the FDA are the first person to blame for not being stringent enough. Of course I believe things can be changed and improved to the current FDA guidelines/regulations, however I don't think the FDA is too rigid/tough since innovation is still occurring (while there is at least watch from the FDA and approvals). There is never going to be a perfect middle ground to balance both innovation and safety, but I think that the FDA have a system in place that is able to prevent some severe issues while keeping some level of innovation occurring simultaneously.
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?
I think that there is a fine line between innovation and safety and the FDA is the responsible party for both. From a company perspective, the FDA (and regulation, in general) is looked at as the bad guy since it impedes the ability to quickly commercialize and take a product to market. However, whenever a product goes awry and faults are found, the FDA are the first person to blame for not being stringent enough. Of course I believe things can be changed and improved to the current FDA guidelines/regulations, however I don't think the FDA is too rigid/tough since innovation is still occurring (while there is at least watch from the FDA and approvals). There is never going to be a perfect middle ground to balance both innovation and safety, but I think that the FDA have a system in place that is able to prevent some severe issues while keeping some level of innovation occurring simultaneously.
