Last week, the US Department of Health and Human Services (HHS) adopted a new rule mandating, at some point later this year after Paperwork Reduction Act approval, that prescription drug advertising on TV contain certain price information. Specifically, HHS will require TV ads for prescription drugs covered by Medicare or Medicaid to include the list price for a month’s supply or for the usual course of therapy, if that price is $35 or more. While some advertising groups argue that this requirement is an unconstitutional infringement on free speech (see this article from the ANA – the Association of National Advertisers), assuming that the rule goes into effect as planned, what effect will the rule have on TV?
Most importantly, the new rules do not impose obligations on TV stations themselves. Instead, the rule looks to the Lanham Act for enforcement. As noted in the HHS rulemaking order, that means that the primary means of enforcement will be by one drug manufacturer suing another for failing to meet the new guidelines under Lanham Act provisions governing false and misleading advertising. Thus, it appears that TV stations themselves will not be principally in the line of regulatory fire on this issue. But, as with any other government-mandated advertising disclosure, broadcasters should be aware of their clients’ obligations to make sure that clients are not putting themselves at risk, and be sure that in any production done for an advertiser, the ads are placed appropriately and presented against a contrasting background for sufficient duration, and in a size and font style that allows the information to be read easily. So far, the rules have not been extended to radio or online, but HHS says that they will monitor advertising to see if future additions are warranted. Obviously, check with your own counsel for more details on this new requirement – and be prepared when one more disclosure likely comes your way later this year.