Charges Drug Marketing Message Overstates Effectiveness Period; Underplays Risk

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WASHINGTON (AdAge.com) -- Consumer-oriented radio and print ads for the day-after contraceptive, Plan B, are inaccurate and overstate the drug's effectiveness period, according to a U.S. Food and
Photos: Women's Capital Corp.
The FDA charges that radio and print ads for Plan B overstate effectiveness and understate risks.
Drug Administration letter to the product's marketer.

Plan B, which has been marketed since 1999 by Women's Capital Corp., can work as a contraceptive if taken within 72 hours after intercourse. Unlike RU-486, it is not an abortion pill.

'Lucky day'
The FDA objected to the phrase in a Plan B 60-second radio ad called "Jane's Lucky Day" that said it was Jane's "lucky day ... because she still has 72 hours after unprotected sex to prevent pregnancy with Plan B emergency contraception." The FDA also chafed at a print ad that read: "Find out how Plan B, taken within 72 hours of intercourse, can be your backup plan in preventing pregnancy. "

The FDA said both ads imply that the product is as effective three days after unprotected sex as it would be if used immediately, and thus does not communicate that "it must be used as soon as possible" for maximum effectiveness. The FDA also wrote that both the radio and print ads don't communicate the drug's risks with the same level of prominence as the potential benefits.

Normally, when the FDA issues a letter of this type, a marketer is forced to pull an ad from circulation. But in this case, the advertising's 10-week trial run on four radio stations in Seattle and in the Seattle Weekly had been completed. The agency was Omnicom Group's DDB Worldwide, Seattle, and the campaign had a budget of $167,000.

Bypassed FDA review
Women's Capital opted not to submit the ads to the FDA for review after the FDA said it would take up to three months to get a review committee together because the emergency contraceptive category was new to DTC advertising, Sharon Camp, Women's Capital president-CEO, told AdAge.com.

Ms. Camp said the company worked with its attorneys to comply with FDA regulations on DTC ads and was frustrated by the FDA's conclusions. Though the FDA wrote the ads "suggest that Plan B is guaranteed to prevent the risk of unintended pregnancy every time," Ms. Camp argued, "I don't think that we were offering any guarantee."

Ms. Camp said the company had planned to launch the ads outside the Seattle test market in Los Angeles in English and Spanish and would have altered them to comply with the FDA's wishes, but it found the ads did not provide a worthwhile return on investment to continue with DTC.

"The really bad news is that we don't appear to have really increased sales in any substantial way in the Seattle area," she said.

She said she did not feel the FDA's letter was politically motivated by the Bush administration since the FDA has supported emergency contraceptives.

FDA constraints
Ms. Camp said she remains frustrated with the challenge of how to advertise Plan B in a way that appeals to young women within the FDA constraints for ads.

"What's frustrating to us is Plan B is the kind of product that if there was ever a reason to do direct-to-consumer advertising, this is the product for which you would do it," she said. "Because unless women know that they have this option they will not be able to use it. Doctors don't market Plan B. They don't market emergency contraception."

Ms. Camp said Women's Capital, which has received funding largely from nonprofit organizations and foundations, plans to file an application in February with the FDA to switch the product to over-the-counter use. The company hopes to turn its first profit in the second quarter of next year.

Plan B can be obtained only by a doctor's prescription except in Alaska, California, New Mexico and Washington. In those states, a person can obtain it from a specially trained pharmacist.

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