PhRMA's New Drug Ad Rules Still Lack an Enforcement Mechanism

Last Updated Dec 10, 2008 8:06 PM EST

henry-waxman_20734_20735.JPGPhRMA has published new rules for direct-to-consumer drug advertising. Although the new rules are more strict than the previous ones, they still have one giant hole in them -- enforcement is non existent. Plus, Rep. Henry Waxman D-Calif., just announced that as head of the Committee on Energy and Commerce, he wants to enact a new ban on pharmaceutical advertising -- raising the question of whether PhRMA's new rules will all be for naught.

Let's look at the rules first and discuss the problems second. These two rules are new:
Companies that choose to feature actors in the roles of health care professionals in a DTC television or print advertisement that identifies a particular product should acknowledge in the advertisement that actors are being used. Likewise, if actual health care professionals appear in such advertisements, the advertisement should include an acknowledgement if the health care professional is compensated for the appearance.
Where a DTC television or print advertisement features a celebrity endorser, the endorsements should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user of the product if applicable.
Interestingly, there seems to be a dovetail between PhRMA's new standards for endorsers and the FTC's new interest in regulating celebrity endorsements in ads. Perhaps PhRMA was trying to head off new regulations?

This is also new:
Companies are encouraged to consider individually setting specific periods of time, with or without exceptions, to educate health care professionals before launching a branded DTC television or print advertising campaign.
Most large companies have already done this, so it isn't too onerous. One rule that hasn't changed is this:
DTC television and print advertising of prescription drugs should clearly indicate that the medicine is a prescription drug to distinguish such advertising from other advertising for non-prescription products.
On its own, this rule should prevent drug sponsorships. But I saw a sports news broadcast earlier this week that was sponsored by Pfizer's Chantix. The logo appeared on the screen, the anchor gave the brand a shout-out, but there was no indication of what the product does.

There are also new rules on providing phone numbers for adverse event reports.

The problem with PhRMA's "guiding principles" remains that there is zero enforcement. PhRMA produces a report giving stats on consumer complaints, but that report comes out about six months after the end of the year that the report covers -- way too late to be of use. Most significantly, the report never names any companies or brands that stepped across the line. If you still want to read the report, you can see it here. Note that there are about 1,000 complaints. That's double the previous year's number.

The lack of accountability is made all the more stark when you compare PhRMA's "zero sanctions" policy to the British Pharmaceutical Industry's Code of Practice. If you break that code, you're expelled from the organization. Last September, Roche was kicked out -- named and shamed, as the Brits like to say -- for selling supplies of Xenical to a guy running a weight-loss clinic who wasn't even a doctor.

The entire exercize may be academic if Waxman gets his way. He told a conference Tuesday that he wants a two-year ban on all advertising of new drug brands. It's hard to believe that's the only new regulation that will be bundled into such a bill, especially as Rep. John Dingell and Rep. Bart Stupak, , both D-Mich., do not think the new rules go far enough.

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