Earlier Senate bill
Already, the industry faces legislation from Sens. Ted Kennedy, D-Mass., and Michael Enzi, R-Wyo., that could dramatically curb direct-to-consumer advertising for prescription drugs. The Senate bill requires a two-year ban.
Reps. Henry Waxman, D-Calif., and Ed Markey, D-Mass., today unveiled the House version, which carries a three-year moratorium.
Besides adding a year to any new-drug ad bans, the House bill also requires packaging to carry a symbol letting consumers know a drug is new to the marketplace. Both bills also mandate pre-clearance of drug ads by the FDA.
Marketing and pharmaceutical groups already upset about the Senate bill are even more unsettled by the House version. Ad groups have been especially worried about the issue this year because Congress needs to reauthorize drug-approval user fees by this fall, making passage of some drug legislation pretty certain.
Jim Davison, a lobbyist for ad groups, said a big fear is that the FDA will impose a blanket ban for all new drugs to avoid the risk that the FDA could be seen as favoring one company over another if it was to selectively block new-drug ads.
"If a two-year moratorium is bad idea, a three-year [moratorium] is worse," he said. "What is the government's interest in grabbing away truthful and non-misleading advertising? If we believe that information helps consumers and helps them to do positive things, then how do we justify taking information away from them? It seems to be counterintuitive, taking the information away from consumers."
Ken Johnson, senior VP of the drug industry's trade group PhRMA, said the nation's pharmaceutical companies are committed to providing accurate educational information and that the group's principles for DTC, adopted in July 2005, are working. He noted a new accountability report tracking the impact of the changes is due within the next several weeks.