Pfizer DTC Guidelines Include New Brief Summary Format

Pfizer intends to use a new "brief summary" format in its direct-to-consumer advertisements, the company said in an Aug. 11 announcement of changes to its DTC policy.

Pfizer has "submitted to FDA for review a new consumer-friendly and consumer-tested print brief summary" as part of an ad for Lipitor .

If FDA approves the "Important Facts" brief summary template, "Pfizer will use this new format in all its print advertising and on all of its product Web sites." A "brief summary" to convey a drug's safety and efficacy information is a required component of full "product and use" print ads.

Pfizer's revised ¹ brief summary format includes seven information boxes: disease awareness; about the product; who the product is for; before you start the product; how to take the product; possible side effects; and a list of sources for further information.

The "possible side effects" section includes lists of both the "most common side effects" and "serious side effects seen in a small number of people."

The bullet-point style of Pfizer's proposed brief summary is similar to the "risk information window" and "highlights" section that FDA is considering as possible alternatives to the current presentation of adverse events and warnings (² (Also see "Risk Information “Window” Proposed By FDA For DTC Print Ads" - Pink Sheet, 9 Feb, 2004.), p. 4).

The new template is based on research performed by Pfizer in partnership with third-party groups including the National Consumers League, the company said.

Pfizer's new DTC policy is part of an effort to "fundamentally change our approach to communicating risk and benefit information," the company said.

"We have come to learn...that there's not much understanding, certainly among the public, among many politicians, and frankly even among physicians about the concept of risk/benefit with drugs," Pfizer Senior VP-Science & Technology Peter Corr said Aug. 9 at the Drug Delivery Technology & Development World Congress in Boston.

Under the new DTC guidelines, Pfizer aims to treat "health as a product" by creating more disease awareness ads, addressing public health issues and promoting its "Pfizer Helpful Answers" program.

"In 2006, Pfizer will invest a meaningful amount - on par with what it spends on a branded advertisement campaign" - on non-product advertising. Pfizer began airing a disease awareness campaign for depression in March (³ (Also see "FDA Takes Relaxed Stance On DTC Ads For Products With “Black Box”" - Pink Sheet, 21 Mar, 2005.), p. 8).

The guiding principles on DTC recently released by the Pharmaceutical Research & Manufacturers of America encourage companies "to promote health and disease awareness as part of their DTC advertising" (⁴ (Also see "PhRMA DTC Principles Compliance To Get Independent Panel Review In 2007" - Pink Sheet, 8 Aug, 2005.), p. 8).

Pfizer's new DTC policies meet, and in many cases exceed, the standards outlined in PhRMA's principles; Pfizer is setting a six-month moratorium on DTC ads for new products, which is not required under the PhRMA guidelines (see ⁵ (Also see "Pfizer Exubera Launch May Demonstrate Impact Of Revised DTC Ad Policy" - Pink Sheet, 15 Aug, 2005.)).

The company will also commence a "dedicated, nationwide TV and ⁶ print advertising campaign" drawing attention to Pfizer's patient assistance programs. TV ads promoting "Pfizer Helpful Answers," the company's umbrella program for its various patient assistance programs, will begin running nationwide Aug. 22. The ads will include information about PhRMA's clearinghouse for patient assistance programs, the Partnership for Prescription Assistance.