PDUFA Fees to Raise Money for Ad Reviews

J0385970 And now, for a commercial break.

At the precipice of the Congressional turnover, the FDA has reached a tentative agreement regarding the review by the agency of television commercials.

According to the Wall Street Journal last week, pharmaceutical companies would pay a sum from $40,000 – $50,000 for each television commercial that they plan to air during the year.  The goal of the agency is to raise $6 million dollars in order to hire new staff to review those ads. 

If you ask me, it would seem like they could get that off the commercials run during the Evening News Hour alone.

Notably, for the Wall Street Journal piece (to which I would link you, but unlike most newspapers that are on-line, they require a subscription) neither the FDA nor the industry organizations would comment.  Thankfully, the Kaiser family foundation has a synopsis for you. 

But this PDUFA development does beg the question that has been raised here before.  As Congress demands more mandate upon the FDA, the costs associated with them go up.  Congressional critics cannot increase the mandates on the FDA over industry and still decry the amount of funding coming from the industry through PDUFA fees, unless it is going to cough up the money. 

According to the WSJ article, a synopsis of which you can find at the Kaisernetwork.org, PDUFA fees generated about $300 million this year for the FDA and under the new negotiations, this would boost by a whopping 30%. 

FDA reform, it would seem, has to be considered in its totality, along with the price tag, or individual mandates will keep upping the PDUFA portion of the FDA budget.  That’s fine with me, but for those who have a problem with it, they better speak up about the big picture, rather than talk each reform on an individual basis. 

This agreement also makes one wonder whether heavier scrutiny of Direct to Consumer advertising will satisfy those critics in Congress who want to bring a moratorium on DTC, or at least reign it in.  And does the agency’s acceptance of fees to monitor advertising affect its policy position on that question?  I don’t know the answer, but the question is an interesting one. 

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2 Responses to PDUFA Fees to Raise Money for Ad Reviews

  1. John Mack says:

    Another interesting question, which I pose on Pharma Marketing Blog (see http://pharmamkting.blogspot.com/2006/11/pay-per-dtc-ad-view-update.html), is what else besides quick review turnaround the drug industry wants in return for the additional money.
    At one point, AZ suggested that any pre-approved ad should be exempt from a subsequent finding by the FDA that the advertisement is misleading or inaccurate. Since the deal is sealed from public view, we don’t know if this is part of it or not.
    PUDFA is just one piece of legislation to watch in the new Congress. I have a list of other potential legislative actions affecting the industry. I am asking experts like you to take my survey on how likely these acts may pass in Congress: See http://www.surveymonkey.com/s.asp?u=764552912613

  2. Dan says:

    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