Drug Makers Set Voluntary Ad RulesDec 11, 2008 | Parker Waichman LLP direct-to-consumer (DTC) drug ads, some in big pharma are looking to enhance advertising to consumers, says Reuters. DTC advertising has come under enormous fire of late for running ads that do not fully explain to consumers the risks and adverse events possible with the advertised drugs.
According to a report on Pharmalot.com, Waxman,—the soon-to-be head of the House Energy & Commerce Committee— said he was looking to give more power to the U.S. Food and Drug Administration (FDA) to regulate DTC drug advertisements. Waxman , who made the remarks while peaking at an industry conference last week, is working to have such ads for newly-marketed drugs banned, Reuters said last week. Such drugs are often available to consumers before a medication’s risks have come to full light, which can place consumers in danger of a drug’s unrevealed adverse effects.
Now, the industry group Pharmaceutical Research and Manufacturers of America (PhRMA) says drug makers will be taking additional steps when it comes to DTC marketing, Reuters said. Among the new voluntary rules being instituted is one that informs consumers when an actor is being used. That rule may be in response to ads Pfizer once ran for Lipitor that featured Dr. Robert Jarvik. In the ads, an actor was used to portray Jarvik participating in vigorous physical activity, such as rowing. The spot was pulled by Pfizer after much criticism.
PhRMA also noted that advertisements geared to adults and not appropriate for children should only be run in media meant for adults, said Reuters. As Reuters pointed out, male impotency drug ads run during programs that children might watch have outraged lawmakers and consumer groups.
According to Reuters, critics of PhRMA point out that the guidelines are voluntary, not FDA-enforceable, not embraced by all in the pharmaceutical community, and exclude device makers and over-the-counter (OTC) drugs. Also, Reuters noted that some advocacy groups feel the guidelines are simply a way to circumvent increased regulation.
"What is needed is meaningful FDA regulation," Peter Lurie of Public Citizen's Health Research Group told Reuters. Lurie was referring to a “ban on celebrity endorsements and allowing the FDA to warn companies without prior review by the agency's lawyer,” said Reuters.
Many lawmakers agree, including Edward Kennedy (D-Mass), chair of the Senate’s health committee. "Voluntary industry guidelines on direct-to-consumers drug advertising are no substitute for effective enforcement of strong regulatory requirements. Patients deserve no less," Kennedy told Reuters.