(CN) – The Supreme Court on Monday declined on Monday to review whether the Food and Drug Administration should make the emergency contraceptive Plan B available without a prescription to women ages 18 and older.
Duramed, which manufactures Plan B (levonorgestrel) had lobbied for over-the-counter availability of its product since 2003. The FDA approved the controversial drug for prescription use in 1999.
Over the years, the agency declined the drugmaker’s applications for general over-the-counter use, and then for such use only by women ages 16 or 17 and older.
After reviewing 47,000 comments in 2006, the FDA approved Duramed’s proposal for a single package for Plan B to be used for both the prescription and over-the-counter populations, labeled “Rx only for age 17 and younger.”
The following year, the Association of American Physicians and Surgeons led a complaint in Washington, D.C., federal court on behalf of groups of physicians, pharmacists and nurses to vacate the FDA’s decision. The court dismissed the complaint in 2008 for lack of standing and noted also that the group failed to exhaust mandatory administrative remedies before filing suit. An appeals court affirmed the decision in a 2009 unpublished order, and the group appealed to the Supreme Court after the appellate declined to rehear the case.
In declining to review the case, the Supreme Court did not issue any comment.
The FDA noted in its response to the group’s petition that the district court rejected each of the group’s contentions for standing, including informational injury, competitive injury, third-party standing and procedural standing.
The association had argued that Plan B’s labeling could mislead its members as to the product’s efficacy information, that making the product available over the counter increased the risk of harm for adult consumers and that its members would lose revenue from office visits by adult patients who no longer need a prescription.