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House Health Subcommittee PDUFA V Hearing Yields Little Talk of Marketing – For Now

Feb. 2, 2012 – More than four hours of testimony before the House Energy and Commerce Committee’s Subcommittee on Health — and members’ follow-up – nearly exhausted the issues related to the Prescription Drug User Fee Act V (PDUFA V) legislation yesterday, but just one question focused on drug marketing.

“It has taken hard work so far to keep direct-to-consumer [DTC] and other marketing on the back burner in PDUFA V,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “But I’m still worried. Consumer and other groups pressed FDA at several points last year in the FDA phase. I don’t think they are going to give up now, so we’re watching carefully and remain prepared for a challenge.”

During the Feb. 1 hearing, medical marketing was raised just briefly. “Do you actually have any resources for DTC advertising monitoring to ensure that consumers do have a balanced understanding of the drugs and the risks advertised to them and the accuracy of those?” Rep. Jan Schakowsky (D-Ill.) asked Commissioner of Food and Drugs Margaret Hamburg, M.D. “Where are we with monitoring these DTC drug ads?” she queried.

“We do have a

group that is charged with working on the oversight of DTC advertising and there is a process that involves the screening of the DTC advertisements,” Hamburg said, adding that “we don’t have fees associated with that.” Hamburg explained that although advertising was considered in previous PDUFA negotiations, “it is not part of PDUFA V.”

Hamburg said she gathered “that in the last PDUFA negotiation this had been identified as a possible area of focus, but actually including it was moved away from for a number of reasons that I think may have included the willingness to … include budget authority.”

“Hamburg’s response is right and appropriate,” Kamp said. “May it be the last word. However, we’re not betting the farm,” he added.

Indeed, although the exchange between Schakowsky and Hamburg was the only mention of drug advertising during this comprehensive hearing, it is unlikely to be the last, especially considering Schakowsky’s ending remark: “Given the prevalence of those ads on television, I would think that should be a major focus and I hope we can work together to make that happen,” she concluded.

Recent efforts by other entities to push for drug marketing restrictions or greater regulation of DTC ads as a part of PDUFA V are worth noting. An Aug. 31, 2011, letter from the Pharmaceutical Care Management Association (PCMA) to the Joint Select Committee on Deficit Reduction called suppressing the use of branded drugs and eliminating the tax deduction for DTC advertising “debt-reducing solutions” that it claims, combined with other prescription drug measures, could save the federal government $100 billion over 10 years.

In highlighting the PCMA recommendation to ban the DTC advertising tax deduction, the letter states that “while the First Amendment allows for such advertising, it does not require tax payers to subsidize promoting the most expensive drug treatments.”

Further, a last-minute plea from a coalition of consumer groups to Department of Health & Human Services Secretary Kathleen Sebelius asked that more marketing rules – including expanded capacity for monitoring of DTC advertising – be added to PDUFA V language.

In tandem, these proposals forward the view that further discussion of marketing in the context of PDUFA reauthorization legislation is likely to rear its head again.

“Once groups like PCMA and Consumers Union take a position, they seldom give up easily,” said Kamp. “It would be naïve to think that our fight is over.”