Plan B Emergency Contraception Focus Is On Unbranded DTC After FDA Letter

Women's Capital Corp. will emphasize unbranded Plan B (levonorgestrel) direct-to-consumer advertising after receiving an FDA letter citing a "misleading" branded campaign for the emergency contraceptive.

Based on FDA's observations and a disappointing sales impact from the branded DTC effort, Women's Corp. said it would be returning to unbranded ads for Plan B.

A 60-second Plan B radio ad and full-page print spot overstate the efficacy of the contraceptive, "fail to convey important limitations on use, and minimize important information about risks," ¹ FDA's Nov. 19 letter says.

The radio ad, "Jane's Lucky Day," aired on four Seattle-area stations, and the print ad "Oops and Uh-oh" appeared in Seattle Weekly. The ads ran in two four-week segments and ended in late October.

Women's Capital said it has no plans to re-broadcast the Plan B radio campaign in other markets, adding that it does not believe it can adequately address FDA's concerns and restrict the spot to 60 seconds. The print ad could be redone as an unbranded poster, the company noted.

Branded ads are also less cost-effective in the emergency contraception market, Women's Capital added, noting that most patients will use the product only once and that the chance of seeing a branded ad while needing emergency contraception is negligible.

The difficulty in advertising Plan B within DTC guidelines emphasizes the need to switch the drug to over-the-counter status, Women's Capital said. The company was expecting to file a switch sNDA this fall, but decided to delay the submission until early 2003 to incorporate soon-to-be-published data.

The World Health Organization is expected to publish a study in The Lancet Dec. 7 that could help support an OTC switch for the two-tablet regimen. The study is expected to demonstrate that taking Plan B up to 120 hours after unprotected sex, or taking the tablets together still offers reasonable efficacy.

Labeling says "optimal efficacy" is achieved by taking the first tablet "as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later."

A second study, scheduled to be released by the Alan Guttmacher Institute Dec. 16, will show a 30% to 40% decrease in the number of abortions due to the availability of emergency contraception. The other emergency contraceptive on the market is Preven (levonorgestrel/ethinyl estradiol), which is manufactured by Barr and marketed by Gynetics.

FDA's letter maintains the ads overstate Plan B's efficacy. For example, the print ad claims: "Find out how Plan B, taken within 72 hours of intercourse, can be your back-up plan in preventing pregnancy. And find yourself uttering phrases like 'Phew!'"

"These unqualified characterizations suggest that Plan B is guaranteed to prevent the risk of unintended pregnancy every time, and they also fail to convey that Plan B is for emergency use only." Preven was cited for similar claims in 1999 ("The Pink Sheet" Feb. 1, 1999, p. 36).

The statements that "'she still has 72 hours after unprotected sex to prevent pregnancy' and 'taken within 72 hours of intercourse' misleadingly suggest that a woman could take Plan B as late as three days after unprotected intercourse with the same likelihood of reducing the risk of unintended pregnancy," the letter maintains.

FDA also cites the ads for minimizing or omitting risk information. The radio ad does not provide "sufficient context" to explain that a women experiencing severe abdominal pain should contact her doctor immediately because it could signal a serious condition, FDA said.

The agency also calls into question the "faster pacing" of the audio presenting the risk information, and says the more serious risks are not "as audible or as well articulated" as the presentation of efficacy.

The radio spot "fails to clearly communicate" the brief summary, FDA said. While the voice-over mentions the Plan B website and phone number, it says the sources will help find a pharmacist, not drug labeling.

In the print ad, effectiveness claims like "Phew! ACCIDENTS HAPPEN. That's why there's Plan B," are presented in larger type than the risk information, which is taken from labeling and appears in smaller type below, FDA said. Both ads also fail to disclose the generic drug name.