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Healthy Skepticism Library item: 14809

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Edwards J.
PhRMA’s New Drug Ad Rules Still Lack an Enforcement Mechanism
BNET 2008 Dec 10
http://industry.bnet.com/pharma/1000485/phrmas-new-drug-ad-rules-still-lack-an-enforcement-mechanism/


Full text:

PhRMA 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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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909