Last year's Pharmaceutical Executive's GUIDE TO BRANDING took a look at the state of direct-to-consumer (DTC) marketing 10 years after the FDA relaxed its guidelines
on advertising pharmaceuticals in broadcast media. The industry's 2006 DTC expenditure was $4.5 billion, representing a 220
percent increase over the 1997 expenditure of $1.4 billion, according to IMS. And while ROI is not always easy to determine,
the median return on investment for brands that employed DTC advertising in the IMS normative database was $2.20 for each
Dale Taylor, AbelsonTaylor
There was, however, a cloud on the horizon that threatened to change the future of DTC promotion—the pending legislation in
both the House and Senate that would authorize FDA to screen all advertisements before public release and impose a multiyear
moratorium on TV advertising after a product had been approved for marketing.
Well, the future is here. And between the courts and Congress, DTC's storm clouds have only gotten thicker. While FDA's plan
for premarketing review of television advertisements legislation was shelved in 2008, it is expected to rear its head again.
The agency's 2009 budget includes a telling increase of $14 million for DTC television ad review.
As for a multiyear moratorium on DTC advertising, that too remains a suspended threat. In June, Merck, Schering-Plough, Johnson&Johnson,
and Pfizer agreed to a voluntary six-month moratorium on advertising new drugs to consumers.
The move came in response to requests from House Energy and Commerce Committee Chairman John Dingell (D-MI) and Rep. Bart
Stupak (D-MI), who heads the committee's oversight and investigations panel.
Dingell and Stupak sought a two-year voluntary moratorium on DTC advertising, and possibly even longer in the case of drugs
for which not all studies have been completed. The lawmakers also asked for limits on the use of doctors in ads and agreement
to Black Box warnings on ads, if requested by FDA.
The drug companies agreed to follow AMA guidelines regarding use of doctors and actors portraying doctors, and not to advertise
off-label uses in DTC ads. In addition, the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed to hold further
meetings with the committee.
Nancy Beesley, HC&B Healthcare Communications
The drug companies informed the committee that the six-month moratorium only formalized an industry practice already in place—to
educate doctors before moving to consumer communications. "We have adopted internal guiding practices on direct-to-consumer
advertising for prescription drugs that requires that our operating companies spend at least six months after approval of
a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign," wrote William
C. Weldon, chairman and CEO of Johnson & Johnson.
Bill Drummy, Heartbeat Digital
Dingell and Stupak said they were pleased by the drug companies' response, but that they still wanted a two-year limit. Stupak
stated: "Although we appreciate the drug companies' willingness to change some of their business practices, they have not
agreed to all of our requests, which would protect consumers from misleading and deceptive advertising. We accept PhRMA's
offer to discuss these issues seriously. We hope the discussions with PhRMA will result in an industry position that addresses
the concerns that Pfizer, Merck, Schering-Plough, and Johnson & Johnson continue to ignore."
Ken Begasse, Concentric Pharma Advertising