SILVER SPRING, Md. — The Food and Drug Administration last month announced that it has approved an amended application submitted by Teva Women's Health to market Plan B One-Step (levonorgestrel) for use without a prescription by women 15 years of age and older. That approval moved Plan B One-Step from behind the pharmacy counter into the family planning section of the pharmacy.
It has been a long process to get Plan B One-Step sold beyond the pharmacy counter with only an age restriction on the sale. Sales for Plan B One-Step totaled $95.4 million for the 52 weeks ended April 21, down 13.4% from the year-ago period, according to IRI sales data across total U.S. multi-outlets. That represents an approximate 53% of the dollar share for the category, which was tracking down 16.1% to $179.6 million in that period.
But the controversy associated with ready access to emergency contraception is not over.
The day following Memorial Day weekend, the FDA was scheduled to plead its case to reverse a district court decision that mandated all levonorgestrel products be placed in OTC sets without any age restrictions at all.