Friday, February 16, 2007

Buying the FDA

Public speaking is a difficult and damning business. When a spokesperson for a company during a time of crisis says something like “Widgetco would never cheat it’s customers,” what one word does one remember from that sentence?

Simple: “Cheat.”

I learned this from one of the masters of public speaking education years ago when I lived in Washington, DC: Merrie Spaeth. She even nominates people who say dumb things in public like this to her “Bimbo Awards.”

So to hear (and read) the FDA commissioner, Andrew von Eschenbach state that “No one is buying the FDA,” I can only hear one word: “buying.”

And with good reason. Doctors are very aware of the effects of lunches bought for our offices by drug companies, of the costs of “free” pens and brochures littering our waiting rooms, and of the effect free samples of drugs distributed to our offices has regarding drug choice. These methods coerce, manipulate, and entice both the physician and patient. To think otherwise is foolhardy.

So it is interesting to hear a similar mantra from the good Commissioner as he relishes the windfall his agency is about to inherit:
"The FDA knows that our actions and our decisions require adequate resources," he added. "We are not focused on where the resources come from, but only the purpose for which those resources are in fact necessary - to protect and promote the health of the public we serve."
They are not focused on where the resources come from?

Well I believe they should be acutely focused.

Particularly since public confidence demands that FDA officials and their “expert panelists” remain impartial and unbiased regarding not only their review of drug approval trials, but for post-market safety monitoring of drugs. The fact that the FDA has “negotiated” a proposal with drug companies for the fees already suggests the companies got something in return. You see, the mere suggestion that the drug companies must “pay to play” is worrisome and erodes public confidence.

Congress must step up to the plate here. The FDA has the unenviable position of raining on the drug companies’ parties frequently in the name of public safety. But once the FDA is bankrolled by the pharmaceutical and device industries, these industries will own its very existence.

Is this what we want?



Sam G said...

Wes, you're right.

Your post refers to PDUFA, the Prescription Drug User Fee Act. Here's how it works.

Drug companies pay the FDA a fee and in return, they get to have their NDA reviewed.

If they choose not to pay, their NDA goes into the trash.


Sam G said...

In other words, Wes, it's just a tax.

Drug companies pay such taxes to a lot of federal agencies. The Patent Office. SEC. You name it. All companies do.

Pay the tax, you get your drug application, your patent application, your S-3 registration statement, reviewed. Don't pay it and you get nothing.

DrWes said...


With the expanded roles Congress has planned for the FDA (advertisement review, post-market eval etc.) the drug companies pay for that review.

But here's the problem: According to the WSJ yesterday in their piece on advertising for impotence drugs, "The renewed attention over the marketing of impotence drugs directly to consumers comes at a time when senators in both parties are focusing on restricting those kind of ads for all drugs, which was on track to hit a record $4.5 billion in 2006."

$4.5 billion. Who pays that? Patients. Who pays the drug review fee? Patients.

Here's another idea: since patients already pay taxes, how about reallocating a few bombs for drug review fees instead? And get rid of ALL direct-to-consumer advertising (like in Australia) while forcing drug companies to get real about their pricing.

I like the idea that we the people would "own" the FDA, rather than the drug companies.

Anonymous said...

The FDA and Its Damaging Lack of Citizen Protection

The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications.

Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should.

The presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.

A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.

This FDA protocol described and proposed is called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.

Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.

However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval.

Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest we as citizens demand, and should be enforced than it appears to be presently.

“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung

Dan Abshear