Direct-to-consumer (“DTC”) prescription drug advertising has been the subject of a great deal of criticism lately. Critics say that all of the money that drug companies are spending on DTC advertising is leading to higher prescription drug costs for consumers. They say that the advertising causes more consumers to ask for (and receive) drugs that they don’t really need. They also say that DTC advertising misleads patients by not fully informing them about a drug’s actual risks. In July, U.S. Senate Majority Leader Bill Frist warned, “It’s time for drug companies to clean up their act. If they don’t, Congress will.”
In August, responding to concerns, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) released its “Guiding Principles” for DTC advertising, which are intended to serve as a set of voluntary advertising rules for drug companies. PhRMA President and CEO Billy Tauzin said, “with these principles, we commit ourselves to improving the inherent educational value of advertisements.” Not everyone is convinced, though. Gary Ruskin, the executive director of consumer advocacy group Commercial Alert, said that the new guidelines are “a public relations exercise that cloaks doing nothing in a stream of verbiage that sounds like doing something.”
PhRMA Guidelines
The new PhRMA guidelines will go into effect in January 2006. Here are some of the key provisions:
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Advertisers should no longer use “reminder” advertising to promote prescription drugs on television. “Reminder” ads are those ads that mention the name of the product, but don’t tell you anything about what it does. The guidelines say that all television advertising “that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.” In addition, both television and print advertising should attempt to present, in a balanced manner, both the risks and the benefits of the advertised drug.
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All new DTC television advertising should be submitted to the FDA before it is broadcast. By requiring advertising to be submitted to the FDA early in the process, this could change production timelines for agencies and production companies.
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When a new drug is released, advertisers should hold off before launching a DTC campaign. The guidelines say that advertisers should “spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication . . . .” PhRMA didn’t specify how long a company should wait • but Senator Frist has argued that companies should hold off for two years.
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DTC television and print advertising should make it clear that the drug advertised is a prescription drug.
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DTC television and print advertising should include information about other options available to patients, such as diet and lifestyle changes. All DTC advertising should also, where feasible, include information about help for the uninsured and underinsured.
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Advertisers should also “respect the seriousness of the health conditions and the medicine being advertised.” According to PhRMA, this doesn’t mean the end to humor in DTC advertising. Rather, this new guideline just asserts that humor and entertainment “may not be appropriate in conveying all messages . . . .”
To give the guidelines some teeth, PhRMA has said that it will establish an “office of accountability” to, among other things, receive comments about compliance with the guidelines and issue periodic reports to the public regarding the comments received and the companies’ responses. While it’s too soon to tell how dramatically these new guidelines will affect the DTC landscape, if you’re going to be producing prescription drug advertising, this is the time to get up to speed.
This column presents a general discussion of legal issues, but is not legal advice, and may not be applicable in all situations. Consult your attorney for legal advice.
Jeffrey A. Greenbaum ESQ. is a partner at Frankfurt Kurnit Klein & Selz, New York. If you have a suggestion for a topic to be covered in a future column, send an e-mail to jagreenbaum@fkks.com
