Despite an independent review board’s 23-4 vote recommending that Barr Pharmaceutical’s morning-after pill, Plan B, be approved for over the counter sale, the Food and Drug Administration this month rejected the company’s plans to make the drug more easily available.
In rejecting the proposal, the FDA contended that Barr had not provided enough evidence about the ability of young women under the age of 16 to understand Plan B’s direction. In a letter faxed to Barr Pharmaceuticals explaining the rejection, the FDA noted that only 29 of 585 women in a company study of the labeling were under the age of 16.
The FDA told Barr it could either propose a system to sell the drug over the counter only to those 17 and over, or conduct another label study focusing on women under the age of 16.
Those advocating making the drug available over the counter called the FDA’s action a thinly veiled political decision in an election year. Dr. James Trussell, who was on the independent advisory board that recommended approving Barr’s plan, noted that numerous other products have been approved for sale over the counter without the FDA raising the issue of whether or not teenager will be able to adequately understand the labeling.
Whether or not the FDA’s decision was political is questionable, but it certainly was a bad decision that appeared to grasp at straws to keep Plan B prescription-only.
Source:
U.S. rules morning-after pill can’t be sold over the counter. Gardiner Harris, New York Times, May 7, 2004.