Barr Campaign To Position Plan B As Second Choice After Primary Prevention

Advertising for Barr Labs' Plan B emergency contraceptive will center on the drug regimen as a "second chance" for users to avoid pregnancy, CEO Bruce Downey told shareholders on Oct. 28.

The "Care Program" is a three-fold message system that "really emphasizes the notion of second choice or second chance," Downey said. The recently developed materials have not yet been used in the field, he noted, but would be used in the event that Plan B (levonorgestrel) is switched over the counter.

According to Downey, advertising will communicate to women that "if your primary method of birth control fails, then by using this product, you have a second opportunity to prevent pregnancy."

Another component of the message stresses "the need to have a primary or a 'Plan A' to prevent pregnancy, a regular contraceptive product if you want to avoid pregnancy," Downey added.

The third aspect will highlight that the product does not protect against sexually transmitted diseases, Downey said.

Barr is planning promotions for its Rx-to-OTC switch candidate, which has not yet been approved for nonprescription use. The user fee deadline for the revised switch petition is Jan. 20.

The new deadline reflects Barr's attempt to switch the drug OTC for women aged 16 and over, but keep it Rx for those under 16.

"We had our outside regulatory counsel prepare an analysis of the legality of this concept," Downey explained. "He concluded - and we concluded - that it was feasible and acceptable under FDA law and we submitted that memorandum directly to the general counsel of the FDA."

"We think we are on firm legal grounds even though it's the first time that it's been done," Downey concluded.

FDA denied OTC approval of the drug, citing concerns regarding a lack of data in young women under the age of 16 in its May 6 "not approvable" letter. Previously, members of FDA's Reproductive Health and Nonprescription Drugs advisory committees voted 23-4 to recommend approval of Plan B for OTC use by women of all ages in December 2003.

"I'm really confident that we'll be able to bring this product OTC and make it available to women who need it in the very near future," Downey maintained.