March 27, 2007
The government would like to see your marketing plan
A bill drafted by Rep. Henry Waxman (D-CA) and Rep. Ed Markey (D-MA) would require preclearance of all drug advertising, empower FDA to impose a moratorium on DTC advertising for up to three years after a drug is approved and require companies to present their marketing plans for drugs on demand.
Washington wags are already calling the “Enhancing Drug Safety and Innovation Act of 2007” “Kennedy/Enzi on steroids,” after a similar bill sponsored by Sens. Kennedy (D-MA) and Enzi (R-WY). The Waxman/Markey bill would:
*require that labeling and consumer ads for new drugs include a “unique symbol” indicating newly approved status for the first two years after approval “or for such period as the secretary determines on a case-by-case basis to be appropriate”;
*Require that the applicant submit to the secretary advertisements of the drug for preclearance, if the secretary determines that such preclearance is necessary,” to be reviewed within 45 days of submission;
*Empower the secretary to require that ads for a particular drug carry “specific disclosures” of the date the drug was approved, noting that “existing information may not have identified or allowed for full assessment of all serious risks of using the drug,” or warnings about a particular “serious adverse event” listed in the labeling;
*Allow for a temporary moratorium on consumer ads for a new drug “not to exceed three years”;
*Empower the secretary to require that manufacturers submit a marketing plan for a given drug “as to allow the secretary to determine whether any of the proposed or ongoing marketing activities undermine any of the requirements of the risk evaluation and mitigation strategy.”
Other sections of the legislation deal with advancing the FDA’s Critical Path initiative and establishing clinical trial registry and results databases.
John Kamp, executive director of the Coalition for Healthcare Communications, said a blanket ban on DTC would violate the First Amendment. “The Supreme Court has never approved censorship as a way to promote an informed population,” said Kamp. “Ignorance is never preferable to education. Congress should never force Congressman Markey to submit his often pithy remarks to a censor before he is allowed to utter them, nor should Congress silence drug companies until some censor can pass judgement.”