Pfizer adopts 6-month DTC moratorium for new drugs, will seek FDA feedback before airing ads

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Pfizer committed to a 6-month moratorium on DTC for new products and vowed to seek FDA feedback before airing new or significantly changed DTC TV ads as the company spelled out its response to PhRMA's guidelines for DTC advertising.

Greg Duncan, senior vice president for U.S. pharma marketing at Pfizer, told MM&M the firm will refrain from advertising to consumers for a minimum of 6 months after a new drug is approved. "This is just a formalization of our long-held belief that we need to educate the physician community before we ask the consumer to have a conversation with their doctor," said Duncan.

PhRMA's new Guiding Principles for DTC say only that firms should spend an "appropriate" time educating physicians about a new product before running DTC ads. Bristol-Myers Squibb has imposed a one-year moratorium on DTC ads for new drugs, and Senate Majority Leader Bill Frist has called for a voluntary two-year ban on consumer ads for new products.

Pfizer also went a step further with its promise to seek FDA feedback before airing TV ads. The PhRMA guidelines pledge signers to submit materials earlier than currently required but do not specify a timetable or require that companies obtain agency approval before running ads.

In addition, Pfizer vowed to spend more on disease awareness promotions and is awaiting comment from the FDA on a simplified brief summary design. A new campaign promoting drug adherence is in the works, and a TV and print campaign touting Pfizer's Helpful Answers patient assistance program will break in the next several weeks.

The company is conducting research into how to effectively communicate risk information, and will apply lessons learned to future ads. "The research suggests that more readily conveying risk information greatly increases the credibility of promotions," said Duncan.

Pfizer ads will also mention other options, such as diet and exercise, that a doctor may recommend for a condition. New Lipitor ads advise patients that the drug "is one of many cholesterol-lowering treatment options in addition to diet and exercise that you and your doctor may consider." The ads, like all Pfizer promotions going forward, also carry information on the Helpful Answers program.

Pfizer promised to air TV ads for Viagra only during programs that have an adult viewership upwards of 90 percent. The PhRMA guidelines mandate adult viewership of 80 percent for products in sensitive therapeutic areas.
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