The FDA has rules set in place in order to prevent higher risk products going into the market or distributed to the public. Though FDA approval can be lengthy tedious, and time-consuming, it does an effective job of ensuring the safety and efficacy of these products. However, in times of public health crisis this can be an issue. One thing that comes to mind for the FDA rules being too strict, is during the AIDS pandemic, there were multiple protests from ACT UP protestors towards the FDA not allowing AIDS patients access to experimental drugs. The death toll was rapidly increasing amongst AIDS patients and AIDS activists were frustrated with how slow the progress was in the FDA approving drugs for dying patients to utilize. The main point that ACT UP protestors conveyed was that with the new AIDS epidemic, many individuals were dying and that testing experimental therapies is itself a form of health care and that access to health care must be everyone's right. Essentially patients who had the disease wanted to grasp at any chance they could at experimental therapies that had been tested significantly but they couldn't get access to them due to them not being FDA approved. They wanted the FDA to shorten the drug approval process due to this public health emergency: specifically they wanted the FDA to ensure immediate free access to drugs proven safe and theoretically effective together with clear information that the drug has not yet been proven effective, so that AIDS patients could properly consent to a potential treatment that could save their life. It is an interesting part of history the battle between the public and the FDA for access to healthcare that I believe more should be aware of. It brings about the perspective and understanding of the drawbacks with having such a strict system and how it could affect individuals especially in times of public health emergencies. 

I agree with most of the posts on this specific topic, the FDA is well within reason for their guidelines because, while there are other organizations that protect public safety. There are many necessary things that the FDA ensures for the safety of humans. As the public, some things we may believe are exaggerated could separate something from life or death.

In no way are FDA rules too strict. Although many manufacturers and pharmaceutical suppliers may face difficulty in bring thir products to market, this ensures that the medical products released to the market cannot cause undue harm to members of the general public. While this sounds like an obvious statement, it does raise a real concern. Many companies claim that FDA regulations prevent the distribution of a wide range of products that could benefit the public, and that the delay in distribution would cause the public more harm than good. While these statements may have truth in them, risking the health of the public is a risk which under no circumstance should be taken lightly. Besides, there are enough pathways by which manufacturers can apply for expedited application if the circumstances justify the means. Without the FDA, there is little difference between certified pharmaceutical suppliers and unsafe street drug peddlers. However, one key area that is of concern is that strict FDA guidelines allow for monopolies to be created among medical device and pharmaceutical suppliers. This allows for large companies to prevent distribution by generic manufacturers, which causes the price of entities like insulin and medical imaging to increase beyond necessity, which in turn raise the prices of the entire US healthcare system. Nonetheless, these concerns are beyond the scope of the FDA, are are the responsibility of other non-medical branches of the government, like the DOJ. For these reasons, the FDA performs its duties in the fullest, safest extent possible.

I believe the strictness of the FDA depends on the food, device, or drug that is under review in that moment. Although the FDA is often strict when a new drug is created or a previous drug is being study to treat additional diseases I don't think their regulations stops the progression of science. Clinical trials and experiments are still ran prior to public use. I believe the FDA delays the ability for the public to benefit from the findings of  science and its research.

I agree with the concern you raised about the FDA that they could slow down the product process and possibly limit innovation in the future. Although the process that a medical product must go through to be approved is sometimes very slow and rigorous, I think it is very useful. It only permits the release of products after verifying their efficacy and safety. This reduces the possibility that the product will endanger people's lives. Also, for new innovative medical products that are classified as a class III device , it is normal and logical that the process that the product must go through to be used by humans must pass a long phase of safety and efficacy control.

Hello,

The FDA has a crucial role in ensuring the safety and effectiveness of drugs and medical devices and their mission to protect public health is important. However, your concern on whether their regulatory processes are excessively rigid, potentially hindering innovation and slowing down the introduction of new and more effective medicines. It's a valid point to consider whether there's a middle ground between stringent regulation and fostering innovation. Striking the right balance is a complex challenge. On one hand, stringent regulations are essential to prevent unsafe products from reaching the market, protecting patients from harm. On the other hand, overly burdensome regulations can discourage investment in research and development, potentially delaying the availability of innovative treatments. Pharmaceutical companies, researchers, patient advocacy groups, and policymakers, are engaged in ongoing discussions for more streamlined approval processes for drugs and medical devices that show significant promise, especially for rare diseases or conditions with no current treatment options. Others emphasize the need for robust safety assessments and long-term monitoring, even if it means longer timelines for approval.

Ultimately, I believe it is better overall to have more stringent regulations than to release medications or devices into the market that have the potential to cause harm to patients.

The FDA is most definitely strict when it comes to its rules and regulations but it NEEDS to be strict. According to their mission statement, the "FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation." Its primary mission is to ensure the safety and efficacy of medical products, NOT to further innovation.

While it may seem like the FDA hampers innovation, I'd argue that it actually enhances innovation. What is the point of innovation if it leads to potentially dangerous products? The FDA  promotes the advancement of safe and effective products. It all comes down to this one question: How do you define innovation?

I think they are strict, but there is a reason why. Do you recall the drug that was used to treat morning sickness in pregnant patients? Do you remember how it caused a lot of birth defects? The reason why the United States did not have that many cases, was because the FDA blocked it. I think the FDA is strict, but I do not know if there is a better way of going about it. What are your thoughts?

I feel as though the FDA is required to be strict in order to keep the public safe. If they loosen restrictions even a little bit, hundreds to thousands of new ideas would come through and may hurt/ be harmful to the public. There is a reason for keeping a standard because if it was not, it could be catastrophic. A hypothetical example would be company x is making a new way to combat company y with this new and improved caffeine pill to keep people up for 24 hours a day and an added benefit is that people loose weight. Company y passed their caffeine pill through the FDA that is what it is now. Company x passes it through the FDA with more lenient restrictions. It is found out that company x's pill gives the user that consumes it a 80% chance of heart attack on the pill. It in turn is where company x says their pill is FDA regulated so it is safe. Would you take that caffeine pill knowing the risks? Hopefully not, which is why the FDA is strict on what they put out to the public.

It’s frustrating for companies, especially smaller ones, because the cost and time involved in getting through the FDA’s process can be super high. I think there’s room for improvement in finding that middle ground—maybe by making the approval process a bit faster for certain lower-risk devices or providing more support for smaller companies trying to navigate the system. In the end, though, the FDA’s focus on safety is essential, but tweaking the process a bit to encourage more innovation could be a win-win for everyone.

When it comes to the FDA, I think strict is a positive. It is of utmost importance that the FDA is strict, unbiased, and efficient to keep American people safe. If we have to choose to lie on one side of this line, I'd choose too strict over not strict enough. However, I do see the argument that the FDA could be slowing innovation. I think this as more an issue with the efficiency of the FDA than the overall strictness. The time it takes for approvals to go through can be excessive, especially for new devices requiring PMAs. The efficiency issue should be solved by higher staffing rather than by lowering restrictions in my opinion. As America is a capitalist society, lowering restrictions could be disastrous with companies out there only looking to make money and not actually worried about patient health. The FDA exists entirely to keep companies from skipping important safety checks in the pursuit of money.  Restrictions should not be pulled back in the pursuit of innovation. 

Hi sahitya-sadineni,
First off I wanted to say that you posed a very interesting topic. I view this discussion in two ways. One one hand, the approval processes for drugs and medical devices are essential for protecting public health. On the other hand, these strict regulations can slow down the approval process of life-saving treatments which require eminent approval. For example, the whole situation with COVID-19. These vaccines were being created for an issue that was a NOW problem as many people were dying. I am not always for controversial opinions , but many think that the vaccine didn't have enough tie to be properly tested and some researchers even link some diseases to it.
https://www.bmj.com/content/384/bmj.q488
Let me know what you think about this topic. Was the vaccine rushed? Did they take the proper action in ample clinical trials? 

The FDA's strict regulations play a significant role in keeping us safe, but sometimes they slow down innovation. The lengthy approval process helps prevent dangerous or ineffective products from being released, but it can also delay new treatments and devices that could help people sooner. A middle ground could involve creating faster approval options for breakthrough products while still keeping safety a top priority. Striking this balance would protect public health and support innovation in medicine.