WASHINGTON - Pharmaceutical companies and the Food and Drug Administration announced separate steps yesterday aimed at curbing misleading advertising that can lead to unnecessary prescriptions.
The industry's trade group issued voluntary guidelines for marketing prescription drugs to consumers, while the FDA said it planned to take a look at advertising practices, the impact of the ads and the agency's monitoring of them.
The announcements come as drug companies and regulators face mounting criticism from members of Congress and consumer groups. The attacks have especially intensified since the heavily advertised painkiller Vioxx was removed from the market last September for a link to heart problems.
The code of conduct unveiled by the pharmaceutical firms yesterday urges drug companies to educate doctors about new drugs before advertising them to the public and recommends that ads better educate consumers about diseases and the risks of taking drugs promoted for treatment.
"You'll see continuing changes about how ads are run - less warnings and less concerns about how ads are run," said Billy Tauzin, who heads the Pharmaceutical Research and Manufacturers of America.
The FDA, which is supposed to make sure drug promotions are truthful, will solicit comment about its advertisement approval process for the first time since lifting limits on marketing directly to consumers in 1997.
"We are looking forward to hearing from consumers, experts in advertising and healthcare professionals to get their reaction and input," said Suzanne Trevino, a spokeswoman. The Wall Street Journal first reported the agency's plan yesterday.
Both announcements were criticized by watchdogs, who have complained that drug companies, with little fear of FDA oversight, are deliberately overstating the benefits and minimizing the risks of drugs in order to increase sales.
Rob Schneider, director of Consumer Union's prescription drug reform effort, said the manufacturers' guidelines "fall short" of the measures needed to make sure consumers receive safe and appropriate prescriptions.
And he said the FDA could without any additional study take substantive steps, such as enforcing a requirement that ads fairly represent the risks, as well as benefits, associated with taking the medicines being promoted.
Sidney Wolfe, director of the Health Research Group at Public Citizen, said: "The industry knows the best way to sell drugs is to oversell the benefits and understate the risks. If industry knows they can get away with that, they will."
