FDA defers Plan B decision

FDA deferred a decision on an application from Barr (BRL) to market Plan B levonorgestrel contraceptive over the counter. The move will give the public time to comment on regulatory and policy issues associated with the application, FDA Commissioner Lester Crawford said Friday. BRL has requested OTC status for women 16 and older and prescription status for younger women. The agency informed BRL in a letter that it has determined that "available scientific data are sufficient to support the safe use of Plan B as an OTC product" for women 17 and older.

The letter added, however, that FDA is unable to reach a decision on approvability of the application because of three unresolved issues. FDA said it had never determined whether a drug may be both prescription and OTC based on the age of the individual using the drug, and how an age-based distinction could be enforced. The agency also said it had never been confronted with whether OTC and prescription versions of the same active ingredient may be marketed in a single type of package. ...