In the decade since the FDA began permitting Big Pharma to market drugs directly to consumers, the ads have become ubiquitous on TV and radio and in print media.
The industry spends $5 billion per year on DTC and no one argues the ads move mountains. For example, ads for the highly effective cholesterol-lowering statins have increased their utilization and almost certainly saved lives as a result.
Rep. Bart Stupak (D-Mich.) for example, never did warm to the DTC concept. In May, he called out Pfizer for Lipitor ads featuring Robert Jarvik, the well-known inventor of the artificial heart because Jarvik is not a practicing physician.
So Big Pharma knew what to expect from Stupak when PhRMA, its trade group announced last week it was tightening its own guidelines governing DTC practices.
The new “voluntary guiding principles” include halting the practice of using actors to role-play physicians on DTC ads, requiring that celebrities cease claiming they use drugs unless they actually do, and ceasing the promotion of drugs for indications not approved by the FDA.
The guidelines also limit ads with adult-oriented DTC content (that would be Viagra and congeners) to programs that normally draw adult audiences.
Stupak offered lukewarm praise and quickly added that the guidelines don’t go far enough.
He wants Big Pharma to wait 2 years after drugs are marketed before releasing ads DTC to assure all drug effects are fully understood. He also wants the FDA’s toll-free number to appear on DTC ads to facilitate reporting of side effects.
Industry spokespeople indicated they’d be happy to review the issue in a few years if critics remained unsatisfied. There’s no chance the issue remains quiet that long.