The drugmaker will provide more details on risks of medications and submit ads to the FDA before they're made public.

01:00 AM EDT on Friday, August 12, 2005

BY NICOLE OSTROW and KERRY DOOLEY YOUNG
Bloomberg News

Pfizer Inc., the world's biggest drugmaker, said yesterday it is changing the way it promotes medicines to consumers in response to the threat of regulation by Congress.

Pfizer said that by the end of the year it will provide more detail on risks, involve doctors at least six months before marketing begins and suggest alternative treatments in some cases. The New York-based company, which announced the changes in a statement, was warned by regulators in April about problems in ads for its Zyrtec allergy drug.

In its statement, Pfizer said it will submit consumer ads to the Food and Drug Administration for comment before they are made public. Next year, the company said it will also invest a "meaningful amount" to create more disease awareness with advertising that doesn't mention a product and address public health issues, including health literacy and compliance.

Drugmakers have been under intense criticism about the $4 billion they spend annually on consumer advertising. A federal advisory panel last year raised concerns about Vioxx ads after Merck & Co. withdrew the drug because of heart risks. Members of Congress, including Bill Frist, the Senate majority leader, have threatened to pass restrictive legislation.

The companies "want to do something before it's done to them." said Les Funtleyder, a health strategist at Miller Tabak & Co. in New York. "Pfizer is the biggest, they spend the most. If they want to declare a truce in accelerating advertising spending I'm sure everyone will be glad to go along."

Some of Pfizer's guidelines are more specific than those set last week by the Pharmaceutical Research and Manufacturers of America. Other large drugmakers, including Roche Holding AG, Novartis AG and GlaxoSmithKline PLC, yesterday endorsed the trade group's rules without issuing additional statements. Eli Lilly & Co. said it is still reviewing the initiative.

"Our advertising is meant to do two things. We want people to be aware of serious medical conditions and our medicines that treat those conditions, and we want to motivate them to talk to their doctors," said Pat Kelly, Pfizer's U.S. pharmaceuticals president, in the statement. "It's our responsibility to communicate this information effectively so patients can work with their health-care providers."

Pfizer spent $667.8 million on consumer advertising last year, compared with Merck's $348.5 million and Johnson & Johnson's $335.3 million, according to data compiled by TNS Media Intelligence in New York. Between January and May, the world's biggest drugmaker spent about $188 million, compared with J&J's $189.6 million and Merck's $113.8 million.

It is not unusual for drugmakers to submit planned advertising to the FDA's drug-ad monitoring unit before running the promotions, said attorney Edward Basile, a senior partner with King & Spalding LLP, who focuses on the FDA, in Washington.

The "companies certainly seem to be taking steps to be more conservative," Basile said yesterday. "Whether they will impose their own restrictions, it is a little bit early to tell."

This year, the FDA sent Pfizer four complaints on its advertising, according to the agency's Web site. Two were official warning letters: one concerned a print ad on Pfizer's Zyvox antibiotic that was intended for a professional journal, and one warned of three "direct-to-consumer advertisements" for its Zyrtec allergy drug.

The Zyrtec ads made "superiority claims" that the agency said "have not been demonstrated."

Last year, Pfizer said it would stop airing some Viagra television commercials after regulators found the impotence treatment ads omitted stating the effectiveness and some risks.

The industry's trade group last week said that 23 drugmakers agreed that direct-to-consumer ads for drugs must clearly describe risks, and that television ads should be age appropriate for the time of day in which they're aired. As part of the agreement, Pfizer and Eli Lilly & Co. said they won't advertise male impotence drugs during the Super Bowl.

The trade group's guidelines, set to take effect in January, suggest companies consider educating doctors about a new drug before advertising to the public. Pfizer has committed to at least a six-month "educational" waiting period.