As Congress Grumbles, Pharma Biz Scrambles

September will be a make-or-break month for direct-to-consumer pharmaceutical advertising, predict two industry insiders who spoke at Rodale Publishing's 10th annual national survey on the subject. With interest in DTC reaching a "fever pitch" in the wake of last year's Democratic sweep, Congress is considering several pieces of legislation that could restrict--or even end--DTC advertising.

Lori Reilly, the vice president for policy and research at PhRMA, a pro-industry lobbying group, said the single biggest threat comes from debate over an odd-sounding acronym, PDUFA (pronounced like "Paducah"), or the "Prescription Drug User Fee Act." PDUFA, up for renewal in September, mandates fees to be paid by pharmaceutical companies to support the FDA review of new drugs. That allows the FDA to hire more staffers, thus shortening the review process.

until now, the PDUFA legislation has not included any provisions regarding pharmaceutical advertising, but members of the Senate have appended various rules and restrictions on advertising to this year's bill.

The final form of the bill is still up in the air, according to Reilly, as a joint House-Senate conference committee wrangles over its actual wording.

In the worst-case scenario, the new bill could include a two- to-three-year ban on DTC advertising. Less drastic, but still costly, would be civil fines of $150,000-$300,000 to be levied every time a "misleading" drug ad is aired or printed. Congress is also considering mandating "black triangle" warnings in DTC advertising, reminiscent of the warnings in cigarette ads. Conveying the anxiety felt by big pharmaceutical manufacturers, Reilly emphasized, "we have no idea where this is going to end up."

And it gets worse. According to Reilly, disagreement between the House and Senate over these extra provisions means there's a chance that PDUFA won't be renewed by the Sept. 30 deadline, in which case the whole pharmaceutical industry--not just its marketing arm--will be disrupted. If PDUFA doesn't pass, the FDA's funds for drug review will dry up, and new drug approvals will slow. It will also limit the FDA's capacity to review and approve drug advertising.

It's no surprise, in this context, that advertisers and publishers are scrambling to defend DTC ads. At the same conference, Cary Silvers, Rodale's director of consumer and advertising trends, presented a variety of data from Rodale's 10-year longitudinal studies debunking some of the most prevalent criticisms about DTC ads. Rather than encouraging consumers to put pressure on their doctors, Silvers argued, DTC ads are seen for what they are--marketing messages that may or may not provide useful information.

Rodale's study suggests DTC ads spur consumers to do more research on the subject, with 47% of respondents saying they encouraged them to "seek more information" about the drug, and 27% saying it prompted them to have a conversation with their doctor. Within this last figure, 73% said they simply discussed the medication with their doctor, while 25% actually asked their doctor for it--or just 8% of the total group who saw DTC ads. Of this group, in turn, 76% actually got the medication they requested--or about 6% of the total.

Furthermore, consumers operate in an increasingly information-rich consumer environment, where the Internet provides a broad array of drug-research capabilities. Indeed, the Rodale study found that more than half of people who asked their doctor about a medicine after seeing a DTC ad continued to seek more information about the drug and related medical conditions afterward; Internet research proved the most popular follow-up.

Curiously, 29% of consumers who begin taking a drug after seeing a DTC ad continue to look at DTC ads about it later, apparently for further fact-gathering. Meanwhile, 41% ask their pharmacists about the medicine, 33% talk with a friend or family member who's taken the drug, and 25% re-contact their doctor about it.