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FDA rules too strict?

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 tgt6
(@tgt6)
Posts: 79
Trusted Member
 

While some may definitely view the FDA as being very strict on its policies, there has to be an understanding that this strictness is put in place for a reason. This harshness that they have challenges the scientists and product developers to create a product with a purpose but also one that will not bring any risk to public health. Having more relaxed guidelines can lead to an oversaturation of products that may or may not have much of a purpose and can also be potentially dangerous. As the question stated, the FDA is just doing its job to keep us safe and that comes with some very strict guidelines to follow. Government intervention is a necessary part of the process of regulation but there needs to be a balance between the amount of intervention that is done in the industry. Having a government that overreaches and becomes too strict can slow down the process and discourage future products to be made but having a government that is too laid back can end up causing damaging effects or bring in too many products with very little function. Finding the ideal point of strictness is something that has been tested for a long amount of time and the way that the FDA is running its process of regulation has been functioning well in the recent past.

 
Posted : 01/10/2022 1:32 pm
(@sandra-raju)
Posts: 38
Eminent Member
 

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. 

 
Posted : 02/10/2022 2:58 pm
(@jadalloyd)
Posts: 24
Eminent Member
 

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.

 

 
Posted : 18/03/2023 11:30 pm
 an83
(@an83)
Posts: 39
Eminent Member
 

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.

 
Posted : 25/09/2023 5:02 pm
 jj52
(@jj52)
Posts: 75
Estimable Member
 

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.

 
Posted : 28/09/2023 11:32 pm
(@31450849)
Posts: 63
Trusted Member
 

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.

 
Posted : 29/09/2023 8:52 pm
(@sah67)
Posts: 78
Trusted Member
 

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.

This post was modified 6 months ago by sah67
 
Posted : 01/10/2023 10:51 am
(@noahyoussef)
Posts: 63
Trusted Member
 

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?

 
Posted : 01/10/2023 12:37 pm
(@fh28)
Posts: 36
Eminent Member
 

Balancing public safety with the promotion of medical advancements is a central challenge for the FDA. Their primary role is to ensure that medical products, from drugs to devices, meet rigorous safety standards. This often involves a comprehensive set of evaluations, including extensive clinical trials, which, while essential, can be lengthy and resource-intensive. Such a meticulous approach is crucial to shield consumers from potential risks. However, it might also postpone the release of potentially life-saving treatments. Some experts in the field believe that the FDA's rigorous criteria could inadvertently hinder groundbreaking research. The significant time and financial commitments required to navigate the approval process, coupled with the uncertainty of eventual approval, might deter some companies from pursuing innovative paths. In response, the FDA has introduced measures like the Breakthrough Therapy and Priority Review to expedite the evaluation of particularly promising solutions. The key is striking an optimal balance. Insufficient oversight could expose the public to risks, while an overly conservative approach might limit medical progress. Potential solutions might involve the FDA fostering more open dialogues during the evaluation process, harnessing real-world data to monitor products post-launch, and consistently refining its methodologies in line with the latest scientific discoveries. The public's trust is also at stake. A perceived laxity in the FDA's approach could diminish confidence, whereas an overly rigorous stance might be seen as obstructing medical advancements. The ongoing challenge for the FDA is to nimbly adjust its strategies to align with the evolving landscape of medical science, all while upholding its primary commitment to safeguarding public health.

 
Posted : 01/10/2023 9:04 pm
(@shahil)
Posts: 67
Trusted Member
 

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?

 
Posted : 08/10/2023 9:31 pm
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