Industry Missing A Public Health Opening With DTC Ads, FDA’s Hamburg Says

The messages conveyed through pharmaceutical direct-to-consumer advertising, and FDA’s role in regulating such promotions, are ripe for re-examination, Commissioner Margaret Hamburg said July 25.

During a talk at the headquarters of the consumer group Public Citizen, Hamburg suggested that manufacturers are missing an opportunity to use their DTC campaigns for broader public health messages.

Public Citizen President Robert Weissman asked Hamburg what she thought about the idea of prohibiting DTC advertising for the first two years a new drug is on the market.

Such proposals, which previously have failed to gain enough traction to pass Congress, have again been floated by consumer groups in connection with the upcoming Prescription Drug User Fee Act reauthorization (Also see "Pressure For More DTC Ad Regulation Begins Again With PDUFA V" - Pink Sheet, 19 Apr, 2010.).

“I have not heard specific calls for the ban that you were discussing, although I’ve certainly heard it talked about as a possibility,” Hamburg said, adding, “I think it’s a good time to look at how we do this.”

"One of the discussions that I’ve been engaged in with industry is how can we use some of the time and money that they’re putting into this to really address broader public health concerns," Hamburg said.

There currently is “a lot of energy” spent by industry and FDA on DTC issues, Hamburg said. “I think it’s a missed opportunity to do something much better if we’re going to be talking about drugs and health to the public at large. Certainly one of the discussions that I’ve been engaged in with industry is how can we use some of the time and money that they’re putting into this to really address broader public health concerns and broader education with the public about important health issues.”

Hamburg sounded a similar note very early in her tenure as FDA commissioner. During an interview with reporters in June 2009, just one month after she joined the agency, Hamburg expressed a desire to work with drug companies to ensure that their product ads contain general information about the conditions being treated (Also see "FDA Chief Hamburg Says Rx Ads Need Broader Disease Information" - Pink Sheet, 18 Jun, 2009.).

FDA’s current regulatory role also warrants another look, she suggested. Although the agency is responsible for reviewing ads, their dissemination is not dependent upon FDA clearance, she noted.

“I think that does create real challenges for us especially with limited capacity, and I think that is something to look at,” she said.

“I am hearing more discussion within industry about the role of direct-to-consumer advertising. I think it has caused them some headaches but obviously it also has some of the benefits and I think it’s an interesting, important time for more discussion.”

A DTC user fee program for FDA advisory review of TV ads prior to airing was included as part of the PDUVA IV agreement in the FDA Amendments Act of 2007. However, the program failed to get off the ground because Congressional appropriators blocked the funding (Also see "DTC User Fee Program’s Demise Leaves Advertisers Bobbing In Its Wake" - Pink Sheet, 21 Jan, 2008.).

By Sue Sutter