The FDA has approved the single-pill Plan B One-Step emergency contraceptive for over-the-counter use without age or point-of-sale restrictions, although the two-pill version remains available to girls younger than 17 only by prescription.
The approval -- announced late Thursday -- complies with an April 4 court order by Judge Edward Korman of the U.S. District Court's Eastern District of New York mandating that all restrictions be removed from use of the emergency contraceptives.
In that ruling, Korman left open the possibility that the FDA could remove restrictions for the one-pill version and not the two-pill version if the agency "actually believes there is any significant difference between the one- and two-pill products."
The FDA exercised that option, keeping over-the-counter access to the two-pill version restricted to those 17 and older while loosening restrictions on the one-pill version. Korman accepted the plan last week.
"On the assumption that the Commissioner of Food and Drugs entertains the good-faith belief that the products should be treated differently, the defendants' proposal is sufficient to comply with my order," Korman wrote.
The complicated history of Plan B goes back to 1999, when the two-pill version of the levonorgestrel-containing emergency contraceptive was approved as a prescription product. In August 2006, over-the-counter access was granted to women 18 and older, although the product would still not be allowed on open store shelves.
About 2-and-a-half years later, in March 2009, Korman found that politics influenced the decision to restrict over-the-counter access to those 18 and older and ruled that the age cutoff should be dropped to 17, as the manufacturer had requested.
That summer, the FDA approved the single-pill version, which was subject to the same age restrictions.
Two years later, the FDA supported removal of all age restrictions for use of the emergency contraceptives, but Department of Health and Human Services secretary Kathleen Sebelius objected, which left the age restrictions in place.
Lawsuits followed, culminating in Korman's April decision to remove all restrictions, which also cited the influence of politics in decision-making surrounding the Plan B products.
But that wasn't the end of it. In May, just a day after approving a plan to expand over-the-counter access to Plan B One-Step to females as young as 15, the FDA appealed Korman's ruling, questioning the judge's legal powers.
Earlier this month, an appeals court stayed Korman's decision to remove age restrictions from Plan B One-Step but denied a similar motion regarding the two-pill version, effectively leaving the Korman ruling in place.
Days later, on June 10, the Justice Department informed Korman that it would no longer appeal his decision and that the FDA would ask the maker of Plan B One-Step -- Teva Women's Health -- to submit a supplemental application for approval without restrictions, which would be approved upon receipt.
Todd Neale
Senior Staff Writer
Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.
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