But in a society where politicians and the MSM get more value for pitting people against each other this is what the result is. "Smart" is discussing your personal situation and plan of options with your physician and making an informed decision. "Doing Google" or taking recommendations from a politician who also injects dangerous toxins into their face to look younger is not advisable....
Monoclonal
- Thread starter SHUSA
- Start date
When something is approved for emergency use, the FDA continuously views if the authorization should still be valid. Part of that consideration is if the product is effective, and if there is an alternative available.
The EUA for Regeneron was reissued 6 times in 2021 because it was still effective.
It no longer qualifies under the framework because it is not effective against Omicron.
That's just how this works.
its still effective to the previous variants the CDC/ US Gov hasnt proved arent still around. They have not proved that the illness it treats isnt still effecting americans. so its not effective against omicron, ok then tell me who exactly has omicron and who doesnt. the burden of proof is on them if they want to take treatments away. they can have regeneron treatments and the omicron treatments. we do go out of our way to impose mandates for 1% of people after all...
this is a political show.
They did prove it.
COVID Data Tracker
CDC’s home for COVID-19 data. Visualizations, graphs, and data in one easy-to-use website.
covid.cdc.gov
Their process is to collect samples / run sequencing and extrapolate the results.
As you can see in that link. The CDC has it as 99.9% Omicron in every region of the country.
In that context....
Regeneron - potentially effective for 1 out of 1000 people needing treatment.
Sotrovimab- potentially effective for 1000 out of 1000 people needing treatment.
Starting to think you went all in on Regeneron stock.
The FDA’s decision is anything but political.
but yes anything revolving around covid has unfortunately been political from the start.
nothing to see here with this decision but don’t you doubt your sources when there is outrage over a correct decision?
what you far right extremes on this board should be wondering is why Desantis and others are still trying to push an expensive Pharma med that doesn’t work now.
Why anyone would pay any attention to ANY politician giving healthcare advice is beyond me....
I love how this guy paints anyone he disagrees with as a "far right extremist." LOL, too funny. But I guess when you're trapped within your own little political bubble, anyone who disagrees seems like an extremist.
Thanks for the laugh, I needed it after sitting through last night's game!
That is true. In this case though, the FDA is not a politician and I'm not really sure why people are arguing we should be using a treatment that the manufacturer says no longer works because politicians want it available.
Yeah I know. I just find this thread odd. Not sure why there is an uproar against ineffective treatments being removed from EUA status.
The FDA is not political, it's biased. The FDA is primarily funded from pharmaceutical companies and major players in the food industry. The money they get comes with strings attached. So when push comes to shove are they going to come out and say don't take the product of the company who is funding us because we have a better alternative if it is in the best interest of the American people?
Well, isn't that exactly what happened here?
The company and FDA said these products don't work for Omicron.
The other products that are still effective are the only options now.
Yes and no. They're still pushing other products of companies that are taking care of them.
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anon_ezos2e9wn1ob0
Guest
The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?
If you were to ask the CEOs of Pfizer, Merck, Lilly, etc., they would be more than happy to drop the “user fees” and have Congress fully fund the FDA via other funding mechanisms.
www.forbes.com
Drug-company-paid user fees under the microscope with beleaguered FDA in funding talks
Fees paid by drug and device makers influence agency operations at the expense of patient safety, critics say.
www.marketwatch.com
Opinion | America Desperately Needs a Much Better F.D.A. (Published 2021)
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
curious what kind of sources you need to know user fees are real, meaning the pharmaceutical companies are their customers. Who wants to piss off a customer?
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anon_ezos2e9wn1ob0
Guest
The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?
If you were to ask the CEOs of Pfizer, Merck, Lilly, etc., they would be more than happy to drop the “user fees” and have Congress fully fund the FDA via other funding mechanisms.
Drug-company-paid user fees under the microscope with beleaguered FDA in funding talks
Fees paid by drug and device makers influence agency operations at the expense of patient safety, critics say.
Opinion | America Desperately Needs a Much Better F.D.A. (Published 2021)
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.www.nytimes.com
curious what kind of sources you need to know user fees are real, meaning the pharmaceutical companies are their customers. Who wants to piss off a customer?
You should read your own article from Forbes.
"One might think that, given the dependence of the FDA on “user fees”, NDA approvals would be a “rubber stamp” process one that was simply a formality. But that’s not the case. As Chen points out, one in five NDAs were rejected by the FDA in 2017 and that doesn’t include those drugs that are pulled in late stage development because they don’t meet the hurdles set by the FDA to justify approval. This failure rate doesn’t support Chen’s concerns about industry favoritism on the part of the FDA."
There are plenty of pharma manufacturers that never bring a drug to market because the FDA does not approve the drug.
I was asked about fees. So your post is irrelevant but I’ll play along. So 80% were approved. It may not be a rubber stamp but it’s pretty damn close. Care to quote the next paragraph where it says things are expedited and the use of limited data? Or you don’t want to do that? It can be justified in rare cases but it’s common practice.
but back to the point of the original question, whether anyone agrees or disagrees with how the FDA process works, they get paid by big pharma through these user fees. That’s a fact. And it muddies the idea of complete independence.
You keep believing that our systems are honest and pure with no corruption and pressures from big money lobbyists. They’re all good people trying to help.
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anon_ezos2e9wn1ob0
Guest
Here is what I know-
In order to bring a pharmaceutical to market the drug undergoes a rigorous process to prove efficacy and safety over multiple years that requires exorbitant amounts of money. PDUFA "User Fees" help the FDA have the resources to perform their job in a timely manner. Would it make sense to invest exorbitant amounts of money, go through a rigorous process over multiple years to then have your NDA sit for 3 years? PDUFA fees are basically a government tax on pharma.
In my line of work I've witnessed multiple emerging pharmas with promising drugs receive a CRL from the FDA or had their drug outright denied. That's game over for them, company goes under.
There will always be corrupt people in all facets of life (law enforcement, pharma, education, etc) because humans are greedy sobs, but I believe the majority of people strive to do good.
While the system we have in place to evaluate new drugs could always be improved, do you have a better idea?
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So you’re saying that article I posted with 0 credible sources was accurate on the fee structure? Simple search with 3 more articles some I don’t necessarily agree with all talk about the same fee system.
With a 20% denial rate I’m curious how much of those denials are the big boys? How many of those denials are little guys who will go under and not be competition in the marketplace for the big boys?
I don’t have a better system because I never thought about creating one but getting rid of lobbyists would be a start. What do lobbyists do that has my best interest or your best interest at heart? Maybe they fight hard so when I watch tv I can see an ad for a drug for 10 seconds then followed by 20 seconds of its side effects that are worse than the original problem.
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anon_ezos2e9wn1ob0
Guest
The largest pharmaceuticals do little innovation of new drug development.
I agree lobbyists are a bad thing, but that's for every industry. Do you have an issue with oil lobbyists?
I agree side effects on some drugs are terrible, but there are many diseases that are debilitating and these pharmas are improving the quality of life for those people.
i’m still curious how often they get rejected.
Yes get rid of all lobbyists. They do more harm than good.
Who would pay that would remove any independence concerns?
There is potential, but that is why they add controls within the company and a ton of regulation for the industry. The FDA employs almost twenty thousand people and a rubber stamp approach for those that fund the company with higher user fees would imply that there are a lot of controls being overlooked and a lot of people looking the other way.
Not that the FDA is perfect. The employees are human and humans make mistakes. I just don't think it is as easy to abuse the approval process as you are implying it is.
Also, while the approval ratio may seem high to you, it costs money for these companies to apply for approval. They aren't going to submit many products that they believe will be denied. By the time they submit something, they believe that the product has a good chance of approval.
You could remove some independence issues without lobbyists and being fully federally funded. I'm sure there are other options. You're an auditor, don't you have to sign off on independence forms? Based on what you sign, do you think the FDA could pass the standard you have to pass when auditing someone. You deal with people's money. As much as we need money to survive, our health is more important than our money. I would hope the FDA has higher independence standards than your auditing standards, but I doubt it.
The other issue is the number of FDA employees who go to work in nice positions for Pharma when they leave the FDA. How tough are you going to be on your potential next employer? I would like to see a law where these people can't go work for Pharma 10-15 years after they leave the FDA.
Yes, I do. Annual and client specific independence sign offs.
There are similar requirements at the FDA.
They do have some rules in place to prevent that type of potential influence on both sides after leaving the FDA or joining the FDA from pharma. Hard to prevent people from earning a living in their field for years just because they worked for the FDA.
Just need to make sure the proper controls and regulations are in place at the FDA to prevent that type of potential abuse. Being such a heavily regulated industry, I do place some faith that the controls that are established are fairly effective.
Thank you. PDUFA fees have been part of FDA funding since 1992 and currently constitute 46% of their total budget. Would you be in favor of eliminating PDUFA and having all FDA funding come from government appropriations?
Agreed. We have the best drug discovery and regulatory process in the world IMO, but is certainly not perfect and there is a lot of money that does get in the way and influences decisions. Just look at the prescription opioid crisis that our government should have intervened long before they eventually did.
We also have what I call a consumption drug economy. There is only one other country that allows direct to consumer drug advertising. We consume close to 40% of the worlds prescriptions with only 4% of the population. (And we are unhealthier). So you wonder why some people are cynical when politicians tell you to get a vaccine? Numbers don’t lie.
In the years prior to PDUFA (before 1992), the FDA was underfunded and approvals came slowly. There just were not enough FDA personnel to handle the backlog of open submissions. Chronically slow approvals are bad for the nation as a whole in the sense that approved drugs are often critical to helping alleviate people's medical issues . Wasting years waiting for approvals is counterproductive.
The other problem is that while a Pharma company waits for approval, the patent clock continues to tick. The longer the approval time, the shorter the period before the patent ends and generic competition arrives. Approved drugs without competition are highly profitable and a portion of those profits support all the failed R&D projects at a Pharma company.
The long wait in the FDA had the potential to incentivize the kind of shady back room deals that have been implied in other parts of this thread. A little money properly applied might bring your New Drug Application to the top of the pile, resulting in a faster approval and increased profits. So the concept that PDUFA contributes to illegal behavior may or may not be true, but we should at least acknowledge the risk has always existed.
46% of their budget is from the group they're regulating in what is a heavily lobbied industry. Combined that with how unhealthy we are as a nation. Based on results I'd say everyone in the industry is getting richer, few are Americans are getting healthier. We work damn hard to get fiber out of food so it have a longer shelf life, food companies make more money, we continue to get sicker and rely on drugs. Everyone wins economically but it seems our health, what the FDA should be protecting is getting worse. Money coming from these user fees is not a good look. Heavy lobbying in these industries is not a good look. At what point does the FDA get some blame for any of this. I would like to see some incentive for the FDA on making our country healthier.
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I'm not a conspiracy guy, but I think we need to be honest and ask some of these questions. Why do we consume a significantly disproportionate amount of prescription drugs than the rest of the industrialized world, but have a resulting unhealthier population? Why are we only one of two countries that allow DTC advertising of prescription drugs? We are clearly a consumption based pharma/healthcare economy and the economic incentives surely support that or else we wouldn't.
It's about results and we have an unhealthy population that is conditioned to treat health problems after years of neglect in many cases rather than pre-emptively. The numbers are the numbers....
If only someone came up with a slogan to Make America Healthy Again. I'm sure everyone would get behind that.
We do use a lot, but not necessarily significantly more than other countries. We just spend significantly more.
Americans Spend More On Top Drugs Than Every Other Country Combined — And It’s Not Because They’re Buying More
Pharma companies make more in the U.S. for 17 of the 20 top-selling drugs than they do in the rest of the world combined.
www.forbes.com
It's true and an interesting dilemma. Should pharma companies be allowed free market capitalism or if we should ban the advertising as other countries have? I certainly wouldn't have an issue with that. Don't think I have ever seen an ad for a drug and then followed up with my doctor about it.
What that article doesn’t provide clarity is on prescription, brand, generic and OTC drugs. In total we consume a lot more.
You may not respond to it but Pharma spends between $6 - 7 billion each year on DTC, so they are getting an ROI on it.
You may not respond to it but Pharma spends between $6 - 7 billion each year on DTC, so they are getting an ROI on it.
