The FDA Is Hooked on Drug Money

There is an inherent conflict of interest in the Food and Drug Administration’s relationship with pharmaceutical companies that endangers the lives of millions of Americans.  The FDA has been giving the green light to more and more dangerous drugs. 

Why? Because the FDA relies on a user fee system that has drug companies pay the agency to have their products reviewed.  How can the agency objectively review drugs and rigorously protect public health when they are taking money from the companies whose products they regulate?  They can’t.

As we mention in our letter to lawmakers, user fees have left behind a trail of banned drugs - and patients who have been needlessly killed or injured by them: Vioxx, Bextra, Tigan and Zelnorm . . .

Pending bills – including the Prescription Drug User Fee Act – contain some laudable provisions but would keep the FDA hooked on money from drug companies.  Some claim that the user fees are a “necessary evil.”  Not so.  Congress must end the FDA dependence on drug company money and instead properly fund the agency through the general treasury.  Our lives depend upon it.

Please tell your senators to vote NO on reauthorizing the user fees.

Comments

[anon]

While the letter you link gives more information than your post, I find both frustratingly short on details and context. Is this a management issue or a "fee" issue? What is the history of budgetary allocations to the FDA, especially in relation to the number of applications over the years, and in relation to PDUFA? Who specifically is making the current FDA budget proposals, and how do they differ from the past? You write: "How can the agency objectively review drugs and rigorously protect public health when they are taking money from the companies whose products they regulate? They can’t." Of course they can! The United States Patent Office requires an application fee for patents. Auditing firms are paid by the companies they audit, but are supposed to be objective – and post-Enron, additional bulwarks have been put into place to prevent conflicts of interest (we'll see if they work). For that matter, writing contests collect fees from participants, and fees are required for all sorts of government services, from driver's licenses to passports to marriage licenses to entering a national park. These FDA fees aren't campaign contributions. It's not as if the drug companies can bypass the process, either! There are many provisions and mechanisms that can be set up to help, but the biggest potential problem would seem to be cronyism. You're arguing against *fees* here, but in the linked letter it seems you really mean to argue against large application fees being used as a significant means of funding the FDA. Okay, then.

You're right that the FDA should get more funding, and it's probably understaffed as well. They also should spend more time in many cases reviewing some drugs. Meanwhile, drug companies should not *lie* to the FDA about their own testing. Morale has been lousy in *many* government agencies under the current administration, and it's a larger issue than a specific funding mechanism for one agency. Correlation is not cause. I care a great deal about public safety and the FDA doing a good job, and I hope in later posts you provide more detail, context, and links. Thanks.

[Johnny]

Hi Angela,

I am having trouble seeing this issue as a conflict of interest. If the pharma fee payments are compulsory by law, then it doesn't matter what the FDA rules, whether in favor of or against various drugs. If on the other hand, the pharma fee payments were voluntary, then of course there would be a conflict of interest because you would essentially end up in a lobbying situation.

I just don't see this as a conflict of interest any more than other compulsory taxes or fees are for any business. Please point out the error in my thinking.

Thanks,

Johnny

[t quigly]

FDA is hooked on drug money - but that's half the story. The other half is the FDA (in cahoots with Rx megaconglomerates) working to outlaw natural/herbal remedies (only those v. expensive and deadly artificial Rx drugs will be legal). There have already been raids on independent health stores and companies. The FDA will require small herbal and natural-products companies to prove effectiveness of their products to such a strict extent that the companies will go out of business (while FDA-'approved' dangerous Rx drugs continue to kill).
Search Codex Alimentarius for more on this attack on our right to determine our health alternatives.

[Ken]

If it's helpful, i did a diary on DailyKos recently that tracks the recent history of the FDA, it's revolving directors, and the negative effect of the PDUFA on public health.
Link is (http://www.dailykos.com/story/2007/4/23/141019/685)
I hope it's of some use. Who knew they gave the FDA to Scotty McClellan's brother?? Then a crook?

[Angela Canterbury]

Anon:

This is undoubtedly a fee issue.

I encourage you to read the open letter sent by concerned academics and former FDA officials to members of Congress which explains how the bill to reauthorize the FDA user-fee system, the Prescription Drug User Fee Act (PDUFA), prevents FDA from performing its essential function of protecting and advancing public health: [http://www.defendingscience.org/newsroom/upload/PDUFA_Open_Letter.pdf]

The user-fee system is completely corrupted not only by the client relationship created by the system and the FDA dependence on the fees, but also by the total impropriety of negotiated fees. These "fees" are directly linked to performance goals for the agency (they are not designed to simply cover the processing costs of an application, for example). More money equals priority review and a quick approval of drugs. These hefty fees account for more than $400 million or a whopping 40% of the agency budget.

There is more on how public health is compromised in the excellent white paper on the user-fee system by George Washington University School of Public Health and Health Services: [http://www.gwumc.edu/sphhs/about/rapidresponse/PDUFA.cfm]

The New York Times agrees with the experts that FDA's dependence on fees is dangerous [http://www.nytimes.com/2007/05/03/opinion/03thu1.html?_r=1&pagewanted=print&oref=slogin]; but so does Richard A. Epstein of the Hoover Institution, who stated in the Wall Street Journal that "It would be better if Congress instead increased its direct appropriation to an FDA that it saddles with ever more obligations." [http://online.wsj.com/article/SB117737754013379878-search.html?KEYWORDS=risky+drug+business&COLLECTION=wsjie/6month]

Would you still like more context and links? If so, there is an excellent summary On the Pump Handle [http://thepumphandle.wordpress.com/2007/04/24/who-supports-fda-user-fees/].

I hope this helps to clarify.

[Angela Canterbury]

Johnny:

One aspect of the conflict of interest is that the "fees" are negotiated by the drug makers. As I explained to Anon, the more money paid to the FDA by a pharmacuetical company, the faster their drug gets reviewed. The fees also make up a large amount of the FDA budget (40%), which means the agency is completely dependent upon the fees for their operations. This threatens the agency's independent review process with dire consequences.

[Johnny]

I see.. Very informative. Thank you.

[Kimba]

It reminds of commerical Institutional Review Boards who are paid a fee to review pharmaceutical companies research protocols. How in the heck can a commerical IRB be bias free? They really cannot!

But then who is going to review these studies? The government? This is all one big shell game with lip service being given to ethics and protecting human subjects and at the same time pharmaceutical companies crying broke and asking that drugs get approved faster and faster. Many of the drugs they develop are duplicative. We the public pays for all of this nonsense with the approval of drugs like Vioxx. No one in investing in herbal remedies because there is no money to be made. Until we put human lives ahead of money we will always have to deal with this conflict on interest! So people speak up and say no more. Tell the lobbyist to take a hike. Challenge our legislators to make some real change.

[Teri Salvador]

It is funny that the FDA allows products in from China that kills people, children and pets, at the same time allowing drug companies to produce drugs that kill in this country. The FDA is too corrupt to be guarding anything to do with the health and well being. There is a criminal conflict of interest between the FDA and the drug companies, as well as the drug lobbyists who pay for political campaigns.