Pfizer Promises to Provide More Detail on Serious Side Effect Risks in DTC Advertisements

Pfizer — the world’s largest pharmaceutical company and the biggest "direct to consumer" (DTC) advertiser of prescription drugs — is changing its ways, perhaps in response to increasing pressure from the FDA and federal lawmakers about DTC advertising.  On August 11, 2005 Pfizer said that by year’s end it will make certain fundamental changes to its promotional efforts, including DTC ad campaigns for its drugs.

As background, in April 2005 Pfizer was warned by the FDA about problems concerning advertisements that the drug company had placed for its allergy drug Zyrtec.  In addition, members of Congress, including Senator Bill Frist, the Republican majority leader, have recently raised the prospect of federal legislation to restrict DTC drug advertising by drug companies.

Just last week, the Pharmaceutical Research and Manufacturers of America — the drug industry’s main trade group — announced that 23 drug companies had agreed to certain new restrictions.  Among those purported reforms, all future DTC drug ads must clearly describe serious side effect risks, and television DTC drug ads should be age-appropriate for the time of day that they are shown (think along the lines of Viagra and the like, here).

Some of the self-imposed guidelines announced by Pfizer go beyond the trade group accord.  In particular, going forward, Pfizer says it will do the following:

• involve doctors at least six months before marketing begins;
• suggest alternative treatments in some cases, such as exercise and lifestyle changes;
• submit consumer ads to the FDA for comment before they were made public;
• ads will provide drug safety information in plain language, starting with an easy-to-read "Important Facts" section (as opposed to the current format, where there is hard-to-read tiny type on the reverse side of print ads);
• invest a "meaningful amount" to create more awareness about diseases with advertising that did not mention a product; and,
• would address public health issues.

Pfizer’s United States pharmaceuticals president, J. Patrick Kelly made this statement in support of the change in course by Pfizer:

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. It’s our responsibility to communicate this information effectively so patients can work with their health care providers.

Insofar that Pfizer is the dominant force in DTC advertising, one hopes that its lead will be followed by the other drug companies.  In 2004 Pfizer spent about $668 million on DTC advertising, compared with $348 million by Merck, and $335 million by Johnson & Johnson, according to a source in the advertising sector.

(Posted by: Tom Lamb)