- The Washington Times - Tuesday, August 2, 2005

The pharmaceutical industry yesterday released stricter regulations for its direct-to-consumer advertising as consumer watchdogs call for tighter government control.

The Pharmaceutical Research and Manufacturers of America (PHRMA), the industry’s trade group, announced a set of 15 guidelines that include requirements such as getting pre-approval from the Food and Drug Administration (FDA) for new direct-to-consumer ads.

“While direct-to-consumer advertising has drawn fire from some quarters, and some of this is well deserved, it is a powerful tool for informing consumers,” said William Weldon, chief executive of Johnson & Johnson, in a conference call yesterday.

Pharmaceutical companies spent more than $4 billion on direct-to-consumer advertising last year, according to data from IMS Health Inc., a Fairfield, Conn., health care services company.

Already 23 major drug companies have pledged to follow the advertising guidelines. Critics argued that the guidelines are voluntary, and they expect marginal enforcement of the rules.

PHRMA plans to collect complaints from the public on direct-to-consumer drug ads and send them to the drug manufacturers. The trade group also will set up an independent panel to report how well the drug companies handle the complaints.

But none of the companies will be expelled from the organization for failing to comply with the rules, said Billy Tauzin, president and chief executive officer of PHRMA.

“We will have a healthy discussion with companies that sign up with the code of conduct and do not follow it,” Mr. Tauzin said yesterday in a conference call.

One of the stronger rules would require drug companies to preview their new direct-to-consumer ads with the FDA, which regulates U.S. prescription drug sales and ads.

Critics say the guidelines do not go far enough to protect consumers from misleading ads.

Public Citizen, a Washington consumer advocacy group, said increased FDA power over direct-to-consumer ads would be the only way to keep the pharmaceutical industry in line.

“The new PHRMA guidelines are a meaningless attempt to fool people into believing the guidelines are stronger than they really are,” said spokesman Sidney Wolfe.

Although the American College of Physicians also advocates more FDA control over drug ads, the Philadelphia medical organization called the guidelines “a good first step.”

“The fact that drug companies are giving the ads to the FDA for approval is a very good step,” said President Dr. C. Anderson Hedberg.

Another guideline would ban “reminder” ads, which the industry has used to mention the name of a drug, but not say what condition the drug treats or its side effects.

The National Consumers League, a Washington-based consumer group, added that it was surprised the drug industry stepped up its efforts to balance the discussion of risks and benefits about a drug in its ad.

“We are encouraged that PHRMA has come up with these principles and that some of them call for the basic information we have been calling for over the years,” said President Linda Golodner. “But I am not quite sure how the accountability is going to work.”

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