Ideas under consideration as PhRMA draws up its draft DTC guidelines include more help-seeking ads, fewer branded ads with more risk information and pre-clearance by the FDA or an industry association.
The trade group is taking a wide-open approach as it circulates ideas among members for comment. One source close to the discussions told MM&M "Everything is on the table."
To address lawmaker concerns about the tastefulness of ED ads running in primetime, drug makers could emulate the distilled spirits industry by restricting such spots to slots with overwhelmingly adult audiences. Brief summaries and risk information might be simplified to a more consumer-friendly format and written at a fifth- or sixth-grade reading level, as Pfizer has done. And companies could, as Pfizer chief Hank McKinnell suggested yesterday, agree to some form of pre-clearance of DTC promotion by the FDA, provided that the agency is capable of vetting materials in a timely fashion.
Though few of these ideas are new, the urgency with which PhRMA is pursing them is. The group has dabbled in establishing DTC guidelines for years, but previous efforts have foundered amid member disagreement and concern that regulators might view such a code as collusion. But with a sensitive period approaching on Capitol Hill and some influential lawmakers eager to rein in the industry, PhRMA chief executive Billy Tauzin has loudly jump-started talks. While a concrete draft is unlikely to emerge until later in the summer, the talks give Tauzin a bargaining tool to use through July 4, when Congress adjourns and legislative inertia sets in.