More than seven months after announcing new draft guidelines for direct-to-consumer pharmaceutical ads, the Food and Drug Administration still isn't finished tinkering-leaving drug companies and their advertising agencies in marketing limbo.
The FDA in February announced proposed changes that would affect the $3.18 billion DTC advertising industry. Those changes included a request for more disease-awareness, or unbranded, spots, as well as a reduction in the brief summary, the tiny-type listing of possible side effects that sometimes takes up a full page in magazine ads.
A 90-day public comment period was supposed to have ended in the spring, and an FDA announcement was expected this month. But now industry observers are wondering when a more formal adoption of the guidelines will take place.
"We haven't heard a thing since winter," said Andrew Schirmer, exec VP-managing director for Interpublic Group of Cos.' McCann Humancare. The result is that agencies are continuing to create ads based on the old guidelines that may well have to be revised later.
"We haven't changed a thing," said a VP-marketing for one of the major pharma companies. "It's been business as usual. We haven't changed the brief summary, and we haven't necessarily done more unbranded ads. And I haven't seen anybody else who has done so, either."
The delay in adopting the draft guidelines appears to be a convergence of factors that one pharma marketing chief quipped was "the perfect storm." One is a reluctance on the part of the FDA to make any major changes prior to the presidential election. The other is that two big DTC advertising proponents, FDA Commissioner Mark McClellan and Associate Commissioner for External Relations Peter Pitts, both have stepped down since the February draft guidance.
"I just don't think you're going to see anything regarding these proposed guidelines this year," said the healthcare agency president. "We went to our clients and said `Hey, we'd like to show you some ideas for creative that incorporate the new guidelines' and they cut us right off and said `Don't worry about it. With a temporary [FDA] commissioner and an election coming up, you won't see anything until 2005."'
Dr. Kathryn Aikin, part of the FDA's Division of Drug Marketing, Advertising and Communications research team, declined to comment and referred calls to the FDA's general press office. Calls to Thomas Abrams, director of DDMAC, and Kristin Davis, regulatory counsel for its Policy and Enforcement Team, were not returned.
DDMAC later released a statement that read: "The FDA is in the process of evaluating the comments submitted. FDA also plans to do research related to the brief summary for DTC ads. That is still in the planning stage at this point."
That surprised some in the industry. "They're going to do more research on the brief summary? It was their idea in the first place to reduce the brief summary," said one healthcare agency president.
feeling the heat
While Novartis did introduce an unbranded campaign for high blood pressure after the February draft guidelines were announced, it was in the works long before the FDA called for more disease awareness spots. And no pharmaceutical company has done any print work that has featured truncated risk information.
The FDA is also feeling some heat from AdvaMed, a trade association for the medical device community. The FDA issued a guidance on broadcast DTC ads for devices such as pacemakers and hearing aids. That guidance asked that ads state the product's intended use and relevant risk information (AA, Feb. 16). In public comments, AdvaMed said the requirements for such devices carry a significantly lesser burden than for prescription drugs and should be treated as such by the FDA.