FDA and medicine companies act to curb advertising abuses

Industry issues guidelines on marketing prescription drugs to consumers

August 03, 2005|By Jonathan D. Rockoff | Jonathan D. Rockoff,SUN NATIONAL STAFF

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."

Senators also voiced concerns. In statements, Sen. Charles E. Grassley, the Iowa Republican who has conducted hearings on the FDA and proposed a bill that would require the agency to review advertisements before they run, said the industry guidelines weren't enough.

"The Food and Drug Administration needs to stop dragging its feet and start exercising its authority to closely monitor the marketing of pharmaceuticals," he said. "It doesn't make sense to rely on drug companies to police themselves."

Senate Majority Leader Bill Frist called the industry guidelines an "important first step" but expressed the wish that they had "gone further."

The Tennessee Republican, who is also a surgeon, has urged manufacturers to wait two years before advertising drugs to consumers, so doctors have time to learn about the products. The guidelines leave it up to the companies to determine how long to wait before advertising.

Drugs marketed directly to consumers, rather than to doctors, are often the biggest sellers.

Since the FDA lifted limits, the direct marketing of drugs to consumers has surged, with ads appearing during the Super Bowl. Drugs for erectile dysfunction and other health conditions are regularly promoted in print and on television.

Drug company spending on advertising has increased 70 percent since 1998, according to TNS Media Intelligence, which tracks the spending. Last year, manufacturers spent $4.1 billion.

But the General Accounting Office reported in 2002 that some companies continue misleading pitches despite FDA warnings, and some fail to submit revised ads for review.

An FDA survey last year found that doctors believe marketing confuses consumers about the risks.

Facing criticism, some companies have already taken voluntary steps. Bristol-Myers Squibb has said it would wait a year before advertising new drugs; Pfizer has said it would submit advertising claims to the FDA before airing them.

The industry-wide guidelines urge manufacturers to stop running television "reminder ads" that don't give the health conditions a drug is designed to treat or the risks of taking the medication. They recommend airing ads at "age-appropriate" times and withdrawing them upon learning of a new safety risk.

The trade group would set up a hot line for receiving complaints and issuing reports to the public. It would also establish an independent board to review the calls and make recommendations.

The association said 23 companies, including such industry leaders as Johnson & Johnson, Merck and Schering-Plough, have agreed to follow the code since its approval Friday.

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