In testimony prepared for a Food & Drug Administration hearing on direct-to-consumer (DTC) prescription drug ads Wednesday, Consumer Alert Executive Director Gary Ruskin called for a ban on all such TV and radio ads.
Ruskin said that DTC print advertising should continue only if it includes the "full FDA-approved label." He also said such ads should not make emotional appeals. Ruskin said it would be impossible for TV and radio ads to meet those criteria, and thus they should be prohibited entirely.
"There is a fundamental flaw in the concept of advertising prescription pharmaceuticals directly to the patient, and that is the inability to provide them complete, meaningful and useful information," said Ruskin. But those were not his words alone. He said he was reading from a statement made by a drug company executive to Congress 20 years ago, when many of those companies were arguing against the DTC ads they are now fighting so hard to preserve.
Ruskin argued that DTC ads do not present accurate, balanced, or understandable information on prescription drugs.
Why not? Ruskin says that drug companies have inherent conflicts that prevent them from presenting unbiased information, primarily that they are out to make a buck, which means to sell more medicine, which means their financial interest is in direct conflict with the public interest in unbiased information.
The same holds, he says, for ad agencies, which he called "institutionally incapable of fairly presenting the risks and benefits of their clients’ drugs. Corporations do not pay millions of dollars to these agencies to sell fewer products, whether of drugs or anything else,"he said.
Responding to Ruskin's testimony, the Association of National Advertisers' Dan Jaffe Wednesday called Commercial Alert's proposal "radical, misguided and unconstitutional."
Ruskin said DTC ads "provide tremendous benefits to consumers and promote public health. FDA studies have found that more than 24 million Americans have discussed a health issue with their doctor for the first time after seeing a prescription drug ad," he said.
Drug company Pfizer in August agreed to at least a six-month waiting period between the time it starts telling doctors about a new prescription drug and the time it starts pitching it to potential patients through DTC ads.
As a member of PhRMA (Pharmaceutical Research and Manufacturers of America) Pfizer had already committed to some form of waiting period, but PhRMA President Billy Tauzin was not committing the association to any set time, saying the waiting period would depend on the drug.
Drug manufacturers last August adopted the new voluntary code for DTC ads, including
- submitting TV ads to the FDA before they run; they have traditionally discussed potential campaigns but have never committed to letting the government pre-screen them
- better balancing risk and benefit info in those ads;
- banning "reminder" ads that don't include educational information, and;
- targeting erectile dysfunction (ED) ads to appropriate age groups.
ED ads, including one in the 2004 Super Bowl, prompted some of the most recent outcry over DTC ads. Ruskin cited the Super Bowl ad—for Cialis—in arguing of the ban.
The drug company moves were also in response to pressure from Washington, particularly Senate Majority Leader Bill Frist, who is a physician. Frist called for a two-year waiting period before advertising prescription drugs as well as the FDA approval to which the industry has since agreed.