FDA "Negotiating" to Get More Money from Big Pharma - Again!

[dustup]

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FDA "Negotiating" to Get More Money from Big Pharma - Again!

Alliance for Natural Health
Tue, 13 Sep 2011 19:24 CDT
 
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Increasingly Pharma is funding the FDA. No wonder the agency seems to dance to their tune.

The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies, allegedly to fund and expedite the drug approval process, but really to pay the agency's bills. Under this authority, pharmaceutical companies pay fees for certain new human drug applications, biologics applications, and supplements submitted to the agency for review - and the FDA's review of an application cannot begin until the fee has been submitted.

The law was enacted in 1992, and Congress needs to renew it every ten years; the next deadline for renewal is September 2012. To make this happen, the FDA has been performing its usual ritual of begging and blustering at the same time.

The FDA has been discussing a raise in the FDA "user" fees with industry since July 2010; in fact, Big Pharma had already agreed to a 6% increase in fees for new drugs through 2017. The increase is expected to produce an additional $40.4 million in user fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million. But FDA still hasn't arrived at a deal with companies on user fees for medical devices - the FDA made a proposal, but industry rejected it, so the negotiations continue.

According to the FDA itself, drug companies provide fully 60% of the FDA's drug review costs - which means that the FDA's review and regulation of pharmaceutical drugs is largely funded by the very drug companies under review!

Could this brand of crony capitalism be part of the reason why the FDA is apparently so biased against supplements, which it regards as competition for drugs? Or why the drugs the FDA approves are so dangerous that, as we reported last year, they kill 50,000 Americans and send more than 700,000 more to emergency rooms each year?

PDUFA is what is known as a "must-pass" bill. Such bills become vehicles for other, smaller bills looking to slide through unnoticed as riders. We will keep a close watch on that - as well as on the FDA's so-called negotiations with its friends in the pharmaceutical industry.
http://www.sott.net/articles/show/234929-FDA-Negotiating-to-Get-More-Money-from-Big-Pharma-Again-

The FDA is like a huge growing Boa constrictor.....ever growing, ever squeezing more from its victims.....It is we the people that have to pay this charge by the FDA through higher cost on drugs......

[lucy]

Because the FDA sanctions the philosophy of "disease management" through surgery and chemical means to keep symptoms at bay without serious intent to CURE even when cures are being found often through natural alternatives that bring no real profit to big PHARMA.

[johnhp]

Because the FDA sanctions the philosophy of "disease management" through surgery and chemical means to keep symptoms at bay without serious intent to CURE even when cures are being found often through natural alternatives that bring no real profit to big PHARMA.

Lucy

i understand this is a sensitive issue but you are really off the mark here.  If you think some cure to a disease has been found through so-called natural means, feel free to post some verifiable source here.

The problem with these medical companies is the privatization of treatments for illnesses.

[ivanm]

"The problem with these medical companies is the privatization of treatments for illnesses."

What alternative are you suggesting?

[johnhp]

"The problem with these medical companies is the privatization of treatments for illnesses."

What alternative are you suggesting?

Given how much the NIH puts into the development of treatments and drugs?  A not for profit consortium in which "profits" are reinvested into research.  i would suggest this be limited to drugs for actual broadly experienced diseases rather than boutique issues such as baldness and erectile dysgunction.

[ivanm]

Given how much the NIH puts into the development of treatments and drugs?  A not for profit consortium in which "profits" are reinvested into research.  i would suggest this be limited to drugs for actual broadly experienced diseases rather than boutique issues such as baldness and erectile dysgunction.

Ok, I think  I see your point. It appears that development of some of the drugs can takes years and mega bucks, so I think it is appropriate for the producer to get a return on the investment.  Granted, the cost of drugs is really out of sight, and I got a bill yesterday for a brand name drug to replace a generic one, and the difference is amazing.
My cost for the old generic was a few cents a day where the cost for this replacement drug is about a dollar a day, and it does even less for me.

Perhaps the fact that in time the patent on a drug expires and permits the competition to come in with generics is the saving grace here as the generics are usually dirt cheap compared to the brand name drugs.  Lipitor is a prime example of the pharmas screwing the ears off of people for years on end, and its patent is about to expire.  It has been one of the most profitable drugs on the market, selling to my wife at a gross price of 3 dollars per pill per day.  Thankfully we pay only a dollar a day and our insurance handles the rest.  I had switched off of Lipitor because it can kill you, and now use another product that is brand name and relatively expensive.

For those of you who aren't familiar with Lipitor, it is used to control cholesterol.  If any of you are using Lipitor you need to study the side effects of it, particularly the one where unexplained muscle pain occurs.  This may be the lead into a very fatal condition. This problem is common with any cholesterol drug in the statin family, even the generics.
Unfortunately there are not many drugs approved for cholesterol control, so the options are limited.  I have  been using Trilipix, 135 mg, and do not have the muscle pains.

[johnhp]

Ok, I think  I see your point. It appears that development of some of the drugs can takes years and mega bucks, so I think it is appropriate for the producer to get a return on the investment.  Granted, the cost of drugs is really out of sight, and I got a bill yesterday for a brand name drug to replace a generic one, and the difference is amazing.
My cost for the old generic was a few cents a day where the cost for this replacement drug is about a dollar a day, and it does even less for me.

Perhaps the fact that in time the patent on a drug expires and permits the competition to come in with generics is the saving grace here as the generics are usually dirt cheap compared to the brand name drugs.  Lipitor is a prime example of the pharmas screwing the ears off of people for years on end, and its patent is about to expire.  It has been one of the most profitable drugs on the market, selling to my wife at a gross price of 3 dollars per pill per day.  Thankfully we pay only a dollar a day and our insurance handles the rest.  I had switched off of Lipitor because it can kill you, and now use another product that is brand name and relatively expensive.  For those of you who aren't familiar
with Lipitor, is is used to control cholesterol.

What you are forgetting is the amount of public money that goes into research for drugs with NO return on that public investment.

[ivanm]

What you are forgetting is the amount of public money that goes into research for drugs with NO return on that public investment.

That is true john.  Maybe some sort of cost sharing and then profit sharing arrangement needs to be made. However, that might lead to favoritism.

Maybe interested companies could bid for the rights to use the results of an NIH research project.  Somehow we need to keep it fair and above board.

[johnhp]

That is true john.  Maybe some sort of cost sharing and then profit sharing arrangement needs to be made. However, that might lead to favoritism.

Maybe interested companies could bid for the rights to use the results of an NIH research project.  Somehow we need to keep it fair and above board.

i would like to see the NIH as a stakeholder in the medicines it develops or helps to develop.  This way the cost of research is lowered and the public can benefit.

[ivanm]

i would like to see the NIH as a stakeholder in the medicines it develops or helps to develop.  This way the cost of research is lowered and the public can benefit.

Some sort of a proportional share of the profits?  That might work. 

Do you really think the NIH people can work cheaper than the private sector does?

 I am wondering, is some of te NIH research farmed out to universities, which would be a  good thing from the standpoint of the public getting some payback or sharing the revenues associated with paying for the research.  For example, KSU in nearby Manhattan, Ks., apparenthy does research for the feds in varlous ways.  It makes jobs for Kansans.

[johnhp]

Some sort of a proportional share of the profits?  That might work. 

Do you really think the NIH people can work cheaper than the private sector does?

 I am wondering, is some of te NIH research farmed out to universities, which would be a  good thing from the standpoint of the public getting some payback or sharing the revenues associated with paying for the research.  For example, KSU in nearby Manhattan, Ks., apparenthy does research for the feds in varlous ways.  It makes jobs for Kansans.

Ivan i know you do not believe this but in the main the government does things more efficiently and less costly than private enterprise.  Look at what the privatization of war did for our debt.

[lucy]

You can do a lot of research on the success of various natural alternatives...and there are a few books out there....will get back to this later.

The body has amazing healing power if given the right nutrients to help it heal.

[johnhp]

You can do a lot of research on the success of various natural alternatives...and there are a few books out there....will get back to this later.

The body has amazing healing power if given the right nutrients to help it heal.

No, i am not talking about pro-industry literature -- and so-called natural remedies are an industry -- i mean serious research that show, for example, success rates.

[dustup]

Lucy

i understand this is a sensitive issue but you are really off the mark here.  If you think some cure to a disease has been found through so-called natural means, feel free to post some verifiable source here.

The problem with these medical companies is the privatization of treatments for illnesses.

Gub'ment protectionism noted........

[dustup]

Ivan i know you do not believe this but in the main the government does things more efficiently and less costly than private enterprise.  Look at what the privatization of war did for our debt.

and who ordered it? ......the privatization of the ME wars ?