Pfizer supports stronger "external oversight" of direct-to-consumer advertising, CEO Hank McKinnell says in his recently released book A Call To Action: Taking Back Healthcare for Future Generations.

"DTC education must meet high standards of accountability," the book says. "It makes no sense for us to develop an ad that we think meets these standards, and then be told later that it doesn't."

"We're ready to find a better way, including working with the FDA to get their views on an advertisement before it is run. We will do whatever we can to support FDA's role in ensuring that patients benefit from thoughtful and appropriate healthcare messages."

Enhanced external oversight is one of four ideas for improving DTC outlined in the book. The others are: (1) improving the content, especially the communication of risk and the availability of alternative therapies; (2) promoting public health; and (3) promoting access to medicines.

McKinnell elaborated on his views about the regulation of DTC advertising during a May 17 press conference in Washington, D.C. as part of the book's launch.

"It seems kind of silly to me that we put an ad on air which later the FDA tells us is not acceptable....They may not have the resources to actually approve it, but certainly we submit everything before we run it, and if they don't like [it] they ought to tell us before we run it, rather than after," McKinnell said.

McKinnell did not discuss specific ideas for enhancing oversight of ads. However, ideas floated in the context of the user fee program in past years include some form of funding for enhanced DTC oversight.

McKinnell's comments suggest that he would be open to the idea of paying fees for preclearance of ads, provided there was some assurance that a company would not be liable to enforcement action after it airs an ad cleared by the agency.

So far this year Pfizer has received a warning letter for the antihistamine Zyrtec (cetirizine) and two "untitled" letters for the antidepressant Zoloft (sertraline) and the NSAIDs Celebrex (celecoxib) and Bextra (valdecoxib). The company also received a widely publicized letter objecting to its Viagra reminder ads at the end of 2004.

McKinnell stressed that Pfizer is taking steps on its own to improve the quality of its direct-to-consumer advertising; the company is specifically focusing on its risk communications.

During the press conference, McKinnell said that Pfizer is rethinking its "traditional" direct-to-consumer ads. "What we've done is pulled back a lot of our more traditional advertising," McKinnell said.

"We are looking at how best to communicate risk and benefits," he said. In the past, "we did a great job in some of our advertising - I'm talking about not only Pfizer advertising, but others - of creating awareness and creating an image of the product, and then in the ad we had blah, blah, blah, blah, blah of the safety," McKinnell said.

"In hindsight [the ads] didn't communicate as effectively as I would have liked," he acknowledged. "It's not that we weren't communicating, it just wasn't very effective."

"My commitment as the head of Pfizer is to improve communication about risk," McKinnell wrote in the book. "We will work harder to ensure that people understand that no medicine is 100-percent risk-free for every patient."

"To do that, we at Pfizer are already reaching out to patient and consumer groups to see how we can communicate risk information in ways that consumers more readily understand." Pfizer is planning to unveil new principles on DTC advertising to reflect that input (¹ [A#00670150007], p. 12).

Pfizer's new series of depression awareness ads are a first step towards the new communications model, McKinnell suggested during the press conference.

McKinnell also applauded Johnson & Johnson's Ortho Evra contraceptive patch ad campaign as an example of sound principles of consumer education.

The J&J ads "have quite a different look and feel and appearance....I certainly applaud J&J for taking the first step there," McKinnell said. J&J CEO Bill Weldon highlighted the ad in his inaugural address as chairman of the Pharmaceutical Research & Manufacturers of America (² Also see "FDA’s Crawford Praises DTC Advertising; PhRMA’s Tauzin Pushes For Change" - Pink Sheet, 2 May, 2005., p. 12).

McKinnell's comments also confirm that Pfizer is rethinking its plans to resume television reminder ads for Viagra (³ Also see "Pfizer Preparing New Viagra Ad; Early Test Of DTC Climate Under Crawford?" - Pink Sheet, 28 March, 2005., p. 27).

While Pfizer is embracing the need to communicate risk better, McKinnell is concerned that FDA's plans for a drug safety website may prove counterproductive (see ⁴ Also see "FDA Safety Website Has Risks Of Its Own, Pfizer CEO Warns" - Pink Sheet, 23 May, 2005.).

In the book, McKinnell suggests another way to improve the content of ads: highlight the availability of alternative therapies.

"In Pfizer's drive to make DTC education even better, our ads will let patients know when alternative therapies are available, including therapies that do not require a medicine, such as diet and exercise," McKinnell says.

"We will also do more to strengthen the relationship between doctor and patient, emphasizing that doctors are the first and best source for help in making the right therapeutic decisions."

McKinnell also pledged to devote Pfizer resources to ads to improve public health.

"Companies like Pfizer know a great deal about informing and motivating people on health issues. We should use these skills to promote the routes to public health, such as prevention and wellness, compliance with treatment regimens, and disease awareness," McKinnell says.

"I have already asked Pfizer's marketing professionals for a plan that would focus on several important public health issues and promote them with the same approaches and resources as we deploy for marketing a branded pharmaceutical," McKinnell wrote.

Pfizer will also continue to promote access to medicines, McKinnell said.

"In the U.S., nearly all the major pharmaceutical companies have patient assistance programs to help people in need get the medicines they need. Our industry should do a better job in communicating about these programs and encouraging people to enroll in them," he wrote.

McKinnell highlighted the "Partnership for Prescription Assistance," a joint effort by PhRMA and a number of consumer, government and professional organizations to simplify access to prescription drug support programs (⁵ Also see "PhRMA Agenda For 2005 Includes Medicare Start-Up, Liability Reform" - Pink Sheet, 22 November, 2004., p. 24).

"I am also committed to more focused communication about Pfizer's many access programs in America, now offered under the umbrella, 'Helpful Answers,'" McKinnell said.

Pfizer Supports Stronger FDA Oversight Of DTC Promotions

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