It looks like Plan A hasn’t worked for Plan B.

The emergency contraception pill won’t be hitting store shelves just yet. Barr Labs, sponsor of an application to make Plan B available over the counter, has been issued a “not approvable” letter by FDA. According to FDA, an actual use study did not provide any data for children under 14 years of age and provided limited data for adolescents 14 to 16 years of age. As a result, the agency concluded that the application did not provide enough information to support adolescents’ use of Plan B without a physician’s supervision.

If Barr pursues the latter option to market Plan B as both a prescription and a nonprescription product, packaging will play an important role in the approval process. FDA will require details of how the company plans to implement simultaneous prescription and nonprescription marketing of Plan B for women of different ages in a single packaging configuration.

Currently, the packaging consists of a carded blister that uses a four-panel, eight-sided card in addition to a patient insert. The package won a 2001 Compliance Package of the Year Award from HCPC. According to Sharon Camp, PhD, founder, president, and CEO of distributor Women’s Capital Corp., the challenge was developing an easy-to-understand discreet package that women would feel comfortable carrying and prescribers would feel comfortable prescribing without seeing the patient. Devising a single package that serves a dual purpose—prescription and nonprescription marketing—could bring new challenges. The package labeling must address two very different audiences and achieve different purposes. FDA calls the dual marketing of Plan B as both a prescription and nonprescription product a “novel approach.” It will be interesting to see if that approach gives rise to novel packaging.