Per their agreement with legislators, Merck, Johnson & Johnson, Pfizer and Schering-Plough will now have to wait at least six months after a drug is approved by the FDA before marketing it directly to consumers. The agreement, confirmed in letters to Dingel and Stupak, was actually far more lenient than the terms originally demanded by the congressmen, who asked for a voluntary two-year moratorium on DTC ads after a drug is approved.
In addition to the six-month moratorium, the companies agreed to limit or halt the use of actors playing doctors in TV ads, and will also include "black box" warnings on ads, if the FDA requests them.
The drug companies are betting that voluntary self-regulation will avert more drastic action by Congress, where Democrats are said to be considering a variety of legal restrictions on DTC ads--the most extreme being a total ban.
Although welcoming the drug companies' decision, Dingell and Stupak nonetheless said they still want a two-year moratorium. And while they are unlikely to see legislative action this year, anti-DTC activists are hoping that a November victory by Barack Obama would give them the political clout needed for stricter legal measures. Obama is said to favor some restrictions on DTC advertising.
The threat to DTC advertising parallels a similar debate about ads for unhealthy foods targeting children.
Under pressure from public health lobbyists like the Center for Science in the Public Interest, last year a group of 11 major food manufacturers led by Kellogg agreed to curtail or eliminate advertising for foods that are high in fat or sugar during TV programs targeting children under the age of 12.
However, their opponents do not consider these voluntary restrictions sufficient; like the anti-DTC activists, CSPI is hopeful that Democrats will pass laws restricting children's advertising sometime after the election.