Draft Discussion Points


The actual use study (AUS) was conducted in five family planning clinic settings across five states and five pharmacy stores in the state of Washington.A total of 585 subjects ages 14-44 years were enrolled from family planning clinics (94%) and pharmacy stores (6%) in the United States.Subjects were only allowed to purchase one package of Plan B, but were allowed additional purchases after undergoing a re-enrollment process.The duration of the study was 4 weeks.



1.     Does the AUS demonstrate that consumers used the product as recommended in the proposed labeling?



2.     Are the data from the AUS generalizable to the overall population of potential non-prescription users of Plan B?



3.     Based on the data from the AUS and the review of the literature, is there evidence that non-prescription availability of Plan B leads to substitution of emergency contraception for the regular use of other contraceptive methods?



4.     Do the data presented in the NDA demonstrate that Plan B is safe for use in the non-prescription setting?



5.     Are the sponsorís plans for introduction of Plan B into the non-prescription marketplace adequate with respect to consumer access and safe use?In answering this question, you may consider other distribution mechanisms such as non-prescription restricted distribution.



6.†† Based on the data presented in the NDA, do you recommend that Plan B be switched from prescription to non-prescription status?


a)     If yes, are there any additions or modifications you would recommend with regard to the proposed labeling and distribution plan?


b)     If no, what additional information would be required?