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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