WASHINGTON — Hoping to head off tighter federal regulation, the pharmaceutical industry announced voluntary curbs Tuesday on consumer advertising, particularly television ads that critics say are skewing medical decisions, glossing over risks and helping to drive up the cost of prescription drugs.
The 15-point plan, announced in Dallas by the main drug industry lobbying group, calls for making sure doctors are fully informed about a new drug's risks and benefits before a public advertising campaign is launched. It would also eliminate one type of commercial -- the brief, so-called reminder ad that mentions a drug by name but makes no reference to possible risks. And, responding to complaints that children are inappropriately exposed to ads for erectile dysfunction drugs such as Viagra, the plan effectively would keep such commercials off programs most likely to be watched by children.
It was not clear, however, whether the industry's relatively modest steps would be enough to hold off growing complaints by some lawmakers, consumers and physicians. The Food and Drug Administration said it was beginning a review of the effect of drug advertising, but it set no timetable for completing it. And some members of Congress have urged stronger measures.
The plan stopped short of setting a specific waiting period before a new drug can be advertised to consumers, a step many consider to be a crucial reform. Experts say that would allow more time to detect rare but dangerous side effects that might not emerge in limited pre-approval clinical trials. Some critics, including Senate Majority Leader Bill Frist (R-Tenn.), have called for a voluntary two-year waiting period.
In a statement Tuesday, Frist said he hoped individual drug companies would seriously consider adopting such a policy. And he refused to rule out congressional intervention.
Defending the industry plan, Karen Katen, a Pfizer Inc. vice chairwoman who was closely involved in drafting the advertising code for the Pharmaceutical Research and Manufacturers of America, an industry group, said, "The heart of the [matter] is that the public wants to see some changes in our ads while preserving the educational benefit of engaging the consumer."
One frequent industry critic, Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, a consumer advocacy organization, dismissed the plan as an industry ploy, saying: "When I saw these guidelines, what it brought to mind was a misleading direct-to-consumer ad. The guidelines appear to be more effective than they really would be."
