WASHINGTON The lawsuit against Barr Pharmaceuticals and the Food and Drug Administration concerning over-the-counter sales of the Plan B contraceptive was dismissed by a federal judge on Tuesday, according to published reports.
A number of groups including the Association of American Physicians and Surgeons had brought the lawsuit in an attempt to discontinue sales to adults without a prescription. Plan B (Levonorgestrel) was originally approved by the FDA in 1999 and the decision to afford the drug OTC status came in 2006. Barr paid $20 million for the drug and its maker, Women’s Capital, in 2004.
The U.S. District Court for the District of Columbia granted the motion to dismiss the suit—which claimed the drug was not proven safe without a prescription—saying the plaintiffs had failed “to identify a single individual who has been harmed by Plan B’s OTC availability,” Reuters reported.
Barr reported that Plan B sales had contributed to its 12 percent increase in overall drug sales last year.
The AAPS said it was reviewing the ruling and had yet to decide whether to appeal.