US is to allow sales of emergency contraceptives without restrictionsBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3837 (Published 12 June 2013) Cite this as: BMJ 2013;346:f3837
Ending a 12 year battle, the Obama administration has decided to abandon its efforts to keep age restrictions on the over the counter emergency contraceptives known as “morning after” pills.
The levonorgestrel based drugs can safely prevent pregnancy if they are taken shortly after unprotected sex, preferably within 24 hours, though they can still be effective up to 72 hours.
But concerns that unrestricted sales of the drugs over the counter would promote promiscuity and undermine parental authority had led to political pressure to limit young women’s access to the drugs.
In addition, although the drugs are thought to prevent pregnancy by suppressing ovulation and inhibiting fertilization, many anti-abortion groups maintained that the drugs also blocked implantation of a fertilized egg and were thus abortifacients.
When approved in 1999 the drugs were made available without prescription only to women 17 years of age or older. Younger women needed a doctor’s prescription.
However, two years later, citing the drugs’ safety and the need for timely access to the drugs, the Center for Reproductive Rights, an advocacy group, filed a citizen petition with the US Food and Drug Administration (FDA) on behalf of more than 70 medical and public health organizations to make the drugs available to all women without prescription.
Years of legal and regulatory wrangling ensued, until 2011, when the US Food and Drug Administration ruled that it was safe to lift all age restrictions on the drugs. But before the FDA’s ruling could be implemented, the secretary of health and human services, Kathleen Sebelius, stepped in, over-ruling the decision and ordering the agency to maintain the restrictions.
This action led to further legal battles, which led a US District Court judge in April to order the FDA to lift all restrictions on the sale of the drugs.
In that decision Judge Edward R Korman lambasted Sebelius, an Obama appointee, calling her over-ruling of the FDA’s decision “politically motivated, scientifically unjustified, and contrary to agency precedent.”
The administration appealed to the US Court of Appeals for the Second Circuit in New York City. But in a ruling last week the court agreed to hear the appeal for only one formulation, a one pill version of the drug, and allowed Korman’s decision lifting all restrictions to stand for an earlier two pill version, the version that had been the focus of the original lawsuit.1
After reviewing the appeal court’s decision, the Justice Department announced on Monday 10 June that it would accept Korman’s ruling, and the FDA said that it would ask the manufacturer of the one pill product, Plan B One-Step, to file a supplemental application for its approval for over the counter sale without restrictions.
But Nancy Northup, president and chief executive officer of the Center for Reproductive Rights, said that its fight would not end while the “administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.”
She said, “We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently.
“But we will continue to fight for fair treatment for women who want and need more affordable options.”
Cite this as: BMJ 2013;346:f3837