This concerns information we covered past in week 2 but I feel like this is a pretty relevant topic.
Based on a recent executive order that Trump has made, it seems that Trump is trying to cut the amount of FDA regulations. The executive order itself amounts to a "one in, two out" policy where an agency will have to identify two regulations to be repealed before instating a new one. This by itself seems pretty unimpactful but at a recent White House meeting, Trump stated, "We’re going to get the approval process much faster," and, “one thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.”
I'd like to avoid purely political discussion and focus more on the possible ramifications of an FDA that has much less regulations. Do you think cutting regulations would result in more terminal patients being saved?
I'll also try to keep this thread updated with future news seeing as Trump has yet to appoint a new FDA Commissioner. One of his supposed choices, Jim O'Neill, was said to favor a "post-marketing approval" mindset, where instead of being required to show both safety and efficacy before marketing as it currently is, a company would instead have to show just safety first, with efficacy shown later. What may be some pros and cons to a system like that?
Sources:
https://www.whitehouse.gov/the-press-office/2017/01/30/presidential-executive-order-reducing-regulation-and-controlling
http://www.raps.org/Regulatory-Focus/News/2017/02/01/26751/Trump-Pledges-to-Gut-FDA-Which-Regulations-Need-to-Go/
https://www.bloomberg.com/politics/articles/2017-01-31/trump-meets-with-drugmakers-as-industry-fears-price-controls
http://www.natlawreview.com/article/how-will-trump-change-fda
Regulation tends to be a very tricky topic. The stances on what should be regulated and how much it should regulated seems to vascillate with each individual. As such, I believe that a flexible policy on regulation, when it comes to the FDA, may prove of benefit to specific populations. The above mentioned group of terminally ill patients may benefit from the ability of drug companies to bring drugs to market faster. However, it should be noted, that many terminal patients are often sought after for participation in clinical drug trials.
However, the primary concern of the proposed deregulation (or softening of existing regulations) is consumer/patient safety. The FDA garnered much of its power due to the thalidomide crisis. Should regulation and surveillance be softened, there is the fear that the population can be exposed to another such crisis.
So the critical question remains, will the benefit of expedited drug production outweighs the potential of a catastrophe.
https://www.cancer.gov/about-cancer/treatment/clinical-trials
This is a really great topic because it is relevant and controversial. My thoughts are these: Trump has the right intent, there are problems within the regulatory practices/policies of the FDA and we need a concrete, forthright solution. However, his idea for a solution, deregulating the FDA/loosening the reins on their approval processes, is dangerous.
Firstly, removing efficacy as a requirement means not being concerned with whether the product will do what it was designed to do. Also, it would seem that any side effects (especially medically concerning ones), as long as they pass safety requirements, would not be a great concern. If a cancer drug causes your eyes to become overtly sensitive to light and your spit becomes radioactive, this would not matter as long as it is killing the cancer. This lax mindset might also impede the desire to improve on any existing product.
Secondly, not being concerned with the welfare of terminally sick patients echos the medical experiments run by Nazi doctors during WW II. Even though they are terminally ill, should they be subjected to the pain and/or serious after effects of an uncertain drug? (This is more of an ethics question). This is what happens when doctors take it upon themselves to determine the public health care system of their nation, they forget about the individual patient.
Thirdly, in their role, the FDA keeps a check on the integrity/honesty of the companies, manufacturers, and people that create new drugs. They make sure no one is cutting corners for a quick profit. Therefore a deregulated FDA would then rely on these organizations as well as doctors and engineers to do the regulating. This is especially dangerous in a capitalist country where businesses are always relentlessly competing with one another to stay alive.
It's indeed a very interesting topic to debate upon. According to the latest data on time taken by FDA on the product approval varies from 6 to 10 months. Relaxing the regulation a bit would definitely expedite the whole process. But at the same time, we don't want another thalidomide episode. Its going to be a big challenge to find an intermediate position in such a case. Its absolutely true that it might save some patients who are about to die in couple of weeks or months. But in reality, it might just add some extra months or years to their life instead of totally curing them until or unless it is some wonder drug which is again an illusion more than a reality. But i would say its definitely a good move if the FDA is using its power to prevent a really good product from coming into the market. So i would suggest that rather than relaxing FDA, another committee or body should be formed which can act as a watchdog on FDA instead.
I agree with everyone. But looking at it from a different point of view.Cutting regulations will save more terminal patients however cutting down regulations can also be harmful for the long term. If a drug is approved based on minimal clinical data, it may save some terminal patients. However, this isn't the ethically correct. This is why Good Clinical Practices and Good Manufacturing practices are present to make sure everything is done according to certain regulations. Cutting regulations may save a few terminal patients but it will compromise GCP and GMPs in the long run. There is a reason these regulations are present to avoid fraud by top companies. These standards are there to detect fraud in reported data.
The only pro would be cutting time to save someone who really needs a drug which showed promising results but cutting regulations makes it easier for companies to report false data and commit fraud to make more money. Money is a huge part in this industry and regulations are there to balance the equation.
This is a great topic for discussion. Accelerating the process of FDA regulation seems like an ideal solution for many critical patients. Although it seems appealing, I believe that it will cause a lot of risk in terms of the safety of those accelerated products. If we turn to go that way and loosen up the regulations, I believe we have to do a lot more of post drug release monitoring. Even with the product being in the market studies should continue to confirm its safety and the FDA will then be able to decide if it stays in market, having its label edited, or withdrawing it all together.
- Lamiaa
I share your concerns with the idea of Trump removing efficacy as a critical step in the approval process. It was because of the need for better efficacy that we avoided the Thalidomide disaster in the United States. The potential for side-effects could be greater, but more importantly, overlooked if efficacy testing loses its place.
The comparison with nazi doctors may be somewhat hyperbole. The nazi's were cold, calculated and barred themselves from many ethical guidelines to perform some of the most brutal research ever conducted. With so much media attention and governmental oversight, it would be very difficult for something like that to ever happen again.
For your final point, self-regulation is the reason why we have the FDA; medical companies don't do it. With the FDA we have standards that apply everywhere, and while they may be complicated, it does keep companies on their toes to make sure they are putting out a product that isn't a threat to the overall public health.
Very insightful post!
I strongly agree with you that cutting them in the first place will cause a lot of of other risks. I believe that for those terminally ill patients maybe they should make an exception to specifically approve this certain medication with limited regulations for those individuals. While it is can be temporarily approved for those patients it should go under the full range of regulation before it is accessible to everyone's use.
Hello eac25, you have brought up a very interesting point. I agree that the FDA sometimes takes a long process in order for it to be used in the market. However I also believe that safety is more important than anything in the industry. Putting products which are not capable of doing their task could lead to deaths and also monetary demands against the company that made the product. So I'm right in the middle of this debate because I agree with both parts so what I think would be the best solution is to keep the same regulations that we have had until now but create a new statement/rule that stated that whenever a patient is about to die, the pills could be used on him/her immediately. If the pill doesn't work then the worst case scenario is that the patient was going to die anyways. However if the pill works the patient could be cured entirely or just make his/her life longer.
I want to add some pros and cons of FDA regulations
Pros-increase public awareness and education regarding the dangers and misuse and over prescribing drugs, FDA plays a “gate keeper” role for consumers, and overall public safety by checking that the device or drug meets the standard for safety and efficacy.
Cons- delaying good products into the market, consumers lose confidence if limit the regulations, and corruption is also involved in many aspects of the process.
Great topic, as a the comment above me mentioned the FDA acts as a " Gate keeper"/ filter for consumers and ensures that good quality products reach the market that have a minimal amount of impact on their well being. That being said, decreasing the FDA's ability to monitor and filter out potential harmful goods could be devastating to our market and could result in another Thalidomide tragedy. I understand that we want to introduce drugs/consumer goods to the market at the faster rate, but at the cost of ensuring safety of the products to the consumer... I don't really agree with that.
Chris
There already is a " right to try" legislation with regards to having experimental drugs given upon the request of a terminally ill patient. I attached two articles below that explains it.
http://www.healthline.com/health-news/right-to-try-movement-wants-terminally-ill-to-get-experimental-drugs-060815#8
Chris
Now that we are 1 year in to this administration and the announcement to overhaul the FDA regulations, I thought this might be a interesting topic to revive. How do you think President Trump's promise to simplify FDA regulations has been accomplished?
Well, so far no medical device regulations have been changed as far as I know. A new FDA head, Scott Gottlieb, was appointed in April. Last fall, Gottlieb solicited input from the Medical Device, Pharma, Biologics and Food industry. He asked for ideas on which regulations to eliminate. This is problematic because when undertaking an improvement project (especially one of this magnitude and impact) it is important to get feedback from all stakeholders. This should also include doctors, hospitals, and most importantly patients/general public.
In my opinion, the Trump administration has shown a lot of dysfunction and incompetence. I don't have much confidence in their ability overhaul the regulations or if they do eliminate regulations it will be what is best for the patient.
