Drug ads on the agenda in the House


The Energy and Commerce Committee's Subcommittee on Health is looking over a multi-pronged bill concerning health in the US. Among the items being considered is a lengthy amendment to the Federal Food, Drug and Cosmetic Act "to improve drug safety."

Among the proposals being considered are a trio that concern advertising policy. For starters, an ad may need government approval: "[t]he risk evaluation and mitigation strategy for a drug may require that the applicant submit…advertisement of the drug for pre-clearance."

The appropriate authorities would have 45 days for review. Second, if there have been any "significant adverse events" or other risk associated with the drug, this must be part of an advertisement, and "advertisements lacking such disclosure would be false or misleading."

Finally, the bill states that "the risk evaluation and mitigation strategy for a drug may require that for a fixed period after initial approval, not to exceed three years, the applicant not issue or cause to be issued direct-to-consumer advertisements…"

SmartMedia observation: On a personal level, we've always wondered about going to our own doctor and announcing our own prescription. However, those in favor of pharmaceutical advertising point out that along with advertising a drug, symptoms are advertised which may inspire someone to seek help when they otherwise might not. It seems possible that the ultimate effect of this would be to simply move a pharma campaign three years down the road. It may be possible to challenge these provisions on First Amendment grounds, but it will be trickier than normal since commercial speech has always been more restricted than most other forms. Stay tuned.