US court lifts restrictions on some emergency contraceptivesBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3760 (Published 10 June 2013) Cite this as: BMJ 2013;346:f3760
A US appeal court has ruled that the Food and Drug Administration must allow sales over the counter of some emergency contraceptives without age restrictions until the court rules on an appeal by the federal government, which seeks to maintain restrictions on the drugs.
The decision is the latest turn in the legal battle over access to emergency contraceptives that began more than a decade ago.
The levonorgestrel based contraceptives, often referred to as “morning after” pills, have been shown to be effective in preventing pregnancy if taken promptly after unprotected sex.
However, the drugs have been controversial,1 because of concerns that they promote promiscuity and undermine parental authority and because opponents of abortion have said that the drugs are abortifacients—though the drugs are thought to prevent pregnancy by suppressing ovulation and impeding fertilization and not by harming a fertilized ovum.
The FDA approved a two pill version of the drug, called Plan B, on a prescription basis in 1999. But two years later, citing the drug’s safety profile and the need for easy access, the advocacy group Center for Reproductive Rights filed a citizen petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available over the counter without a prescription.
A long series of legal and regulatory battles ensued over the next decade, during which time the FDA approved versions of the drug in one pill and made all formulations of the drug available without prescription to women aged 17 and over but maintaining the requirement for a prescription for those aged under 17.2 3 4 5 6
The new decision issued 5 June by the US Court of Appeals for the Second Circuit in New York City was in response to a lower court’s ruling that the FDA must make the drugs available to women of all ages without restrictions.1
In that previous ruling Edward R Korman, US district judge for the Eastern District of New York, denounced what he said was political interference in the FDA’s approval process.
The government’s lawyers then went to the US Court of Appeals for the Second Circuit asking for a stay of Korman’s ruling, pending appeal.
In the latest ruling, issued 5 June, the Court of Appeals agreed to grant a stay for one pill versions of the contraceptives but, on technical grounds, denied to stay Korman’s order concerning the two pill version.
The decision meant that the FDA must approve the over the counter sale without age restrictions of two pill versions of the emergency contraceptives, while the fate of one pill versions remains in the air, pending the appeal court’s review.
The upshot of the decision is that, for now, the less convenient and less popular two pill versions will be available over the counter without age restrictions; that most other one pill versions will be available over the counter only to women aged over 17; and, because of a recent FDA decision, one brand of the one pill formulation, called Plan B One Step, will be available without a prescription to women aged 15 years or older.
The FDA and the Department of Justice, which represents the government in this case, have said that they will review the appeal court’s decision before deciding whether to appeal the case to a higher court.
The Court of Appeals has promised an expedited review of the government’s appeal in regard to the one pill version.
Cite this as: BMJ 2013;346:f3760
bmj.com Observations: Science trumps politics on emergency contraception (BMJ 2013;346:f2217, doi:10.1136/bmj.f2217)