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?
The FDA does seem strict when it comes to certain restrictions. The regulations that FDA puts on the release of products seems to slow down the process. When companies create products to be released, once they start to classify the product according to the FDA rules, they might have to put their product on hold to improve their product to fit the FDA regulations. As a result, this causes the product to have a later release date. Although it does slow down the process, it is beneficial. It allows for products to only be released only after ensuring the safety and efficacy of it. This 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.
I can see why many would think the FDA are being strict and potentially hampering the journey of medical devices. However, the FDA is a regulatory board and its main job is to be an overruling force. If the FDA were to lax its rules, many companies will take shortcuts to bring the device to the market a lot quicker. This may result in a lot more cases of damage to the general population. Companies can argue that certain rules and regulations are stretching the power of the government, and in certain cases I agree. However, it is hard to nitpick over specific rules. The FDA has been in this position for a long time and has accumulated years of data. This data would be a benchmark to see if their rules and regulations are too much or are they working fine. There will always be recalls of medical devices, but with a strict government agency in place to look over it, a lot more recalls are prevented.
The standard example generally given to justify the FDA's rules is Thalidomide, which resulted in thousands of babies being born with deformed limbs because their mothers used it during pregnancy. Hailed as a wonder drug that treated insomnia, mild depression, and morning sickness, it was available in most of Europe but had not been approved for use in America. The advantage of strict FDA rules is obvious, given this example.
The main disadvantage is the massive barrier to market entry presented by FDA rules. Drugs can take billions to develop into marketable products (when pricing in the cost of failures). This means that no one, aside from megacorporations, can produce new drugs. Medical devices are generally cheaper, but rules still frustrate many would-be developers.
The problem is both alleviated and exacerbated by the regulatory capture of the FDA. Companies with more influence may face an easier time with FDA approval, which lowers their R&D costs but makes us less safe and raises entry barriers even higher.
It is clear that compromise is necessary to ensure the safety of Americans while encouraging investments into new medical device and drugs. But I lean toward strict safety requirements - it seems likely to me that more lives would be lost due to laxer rules than would be saved with faster approvals.
I agree with the points you made; the regulations of the FDA do, indeed, protect us and the compromise is worth the lives being saved.
However, I feel that there is still room for improvement in the system that is in place. The two biggest drawbacks to regulation are the incurred cost and the lengthy timeline of approval. Without compromising the standards of FDA regulation, there could be an effort to subsidize the cost of medical device development and pharmaceutical development for smaller companies. An effort like that could help bring new drugs to the market sooner and in a manner that is monopolized by larger businesses.
While this solution is entirely speculative, I feel that it is the only way to adjust the FDA without compromising its purpose of protecting the US population from the adverse effects of drugs and medical devices that come to market.
I believe that the FDA's strict rules are necessary to protect the public and what they consume on a daily basis. Although there is a long process that needs to be taken in order to get a drug on the market, it definitely has it benefits, making sure that the drug or device has gone through clinical trials and it has produced enough data that it can be deemed safe. One good example that can be used to demonstrate this is the use of thalidomide when wome
I understand where you are coming from when it comes to restrictions. I can see how the FDA can cause unnecessary hindrance. But I'd rather have a strict agency then even if it may cost the industrial companies some time. One aspect of the FDA I do wish was more involved is strict is the dietary supplement sector. "The terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (meaning those that had been sold in the United States before 1994) can be marketed without any evidence that they are effective or safe." I understand this is meant to reduce redundancy but with American spending billions of dollars on supplements, I believe there should be a more active role by the FDA even if the effects of a lot of supplements are similar to placebo.Anything that is said to affect health should fall under the scrutiny of the FDA.
FDA is not rigid instead they're doing their best to protect public health by assuring the safety and efficacy of drugs. It will be devastating to its mission statement if a life-threatening product is approved and release to market. The government intervened in 1999 and 2012 passing laws to reduce slowing down the process of products.
The new legislations: The Prescription Drug User Fee Acts (“PDUFA”), and the 2012 FDA Safety and Innovation Act. These two laws focused on performance goals for the FDA in terms of reduced review times. With the FDA Safety and Innovation Act, FDA now flushes with new funding from charges drug manufacturers fees for drug applications and since then generic drug approvals has reached record highs.
FDA need to be rigid and strict in order to make sure that good quality products are launched which in any way does not harm people on use, because they are someone who are trusted by so many people with there life. I would also agree that the way FDA approval procedures are laid that is somethings that takes long for approval. If FDA tries to restructure the approval process and to some extent simplify the process this would increase the number of product approved and also make sure the products that are launched are also safe.So I think the barrier between the safe and sound product and rate at which they are approved is something which can be diminished by simplifying and restructuring the procedure.
In order to prove my point I would like to co relate toxicity table. What if you have a implant ready and you forget to do or think that Genotoxity test in it is not important just on the fact that its not necessary. But things like this would not happen if FDA comes into picture and if they have enough power. So i think FDA has been great in its jobs its just that it need some changes to make it a win-win situation for both manufacturer and also for consumers.
I believe that the FDA's strict rules are necessary to protect the public and what they consume on a daily basis. Although there is a long process that needs to be taken in order to get a drug on the market, it definitely has it benefits, making sure that the drug or device has gone through clinical trials and it has produced enough data that it can be deemed safe. One good example that can be used to demonstrate this is the use of thalidomide when women were pregnant. The drug was used to treat morning sickness, but it was never tested on animals that were pregnant. And thus, as a result, many women who used the drug gave birth to children with severe defects and missing limbs. To prevent this from happening again, the regulations should be tightened to save many lives. This does not only benefit patients, but it also benefits the scientific community by allowing them to follow protocols and perform clinical exams to ensure the safety of everyone.
(posted again, previous post got cut off).
Its not just Dietary supplements that the FDA needs more regulation on. some prescription drugs get to market unapproved. when the FDA finally gets around to getting these drugs off the market, the companies are given a long period of time to stop making and distributing them. "FDA officials expect companies that have listed products with the agency (Physicians desk reference) to stop making them within 90 days, and to stop shipping them within 180 days." they are given far too much time for some drugs that have "potentially life-threatening side effects". and because some companies don't update the FDA with all the drugs they make, the FDA is unaware that some drugs even exist on the market.
https://consumer.healthday.com/respiratory-and-allergy-information-2/misc-allergy-news-17/fda-bans-unapproved-prescription-cough-cold-and-allergy-meds-650504.html
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm
The FDA is strict largely for the protection of the general public. Without these measures in place, there is a greater ability for dangerous products to make it out into the market. I believe the crux of the issue lies with the potential of this strictness to hamper innovation or experimental drugs and devices. I believe that there is adequate room for innovation and experimentation. But the FDA does limit it and keep it on a small scale, as this is to maintain safety for the general public.
I feel like the FDA approval process seems like it is too strict compared to regulations in other countries, but I agree that the FDA is right in being as extensive as it is. The FDA was originally put in place to regulate the food industry because there was no way of proving that labels were accurate as to what companies were putting in the product. Since then the FDA has overseen the medical device and drug industries to ensure efficacy of the products and protect the consumers. For products classified as class iii devices, a sufficient amount of evidence is needed in order to ensure a product is safe enough to be used in situations where they are supporting/sustaining life.
The processes laid down by the FDA maybe lengthy and tedious but they are not too strict. Without the FDA, there aren't many other government organizations or groups that can be as effective in delivering rulings, and regulations over the vast amounts of medical devices, drugs and other consumer products that are released into the market every year. The FDA has drastically improved the safety of medical devices and its practices in the country. Many other countries lack such regulation, and as a result their medical care is much more risky and dangerous. The amount of testing the FDA requires by medical device companies helps to prove the accuracy and precision of their products.
I Feel FDA rules are more like a filter to bad products from entering into market. With lot of competition in the market, some companies tries to cut corners and save time or even money. Since, any company’s main motto is to create a product that makes money and have a good business plan, FDA has to intervenes and protect public health by assuring the safety and efficacy of drugs or devices. As a0242 mentioned, FDA is not too rigid. Moreover, it has been amending acts and rules to fit the needs of present day scenario based on the market and needs.
