US approves “morning after” pill without prescription for women 15 years or olderBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2909 (Published 03 May 2013) Cite this as: BMJ 2013;346:f2909
The US Food and Drug Administration has approved the use of one brand of a “morning after” emergency contraceptive without a prescription for women 15 years or older.
Previously, the FDA limited non-prescription sales of the drug, Plan B One-Step, to women aged 17 years or older. Those aged 16 or under could obtain the drug but only with a prescription.
Under the new FDA rules the product will also be available on shelves in store aisles where other family planning and women’s health products are displayed. Previously the product had to be kept behind pharmacy counters and not on open shelves.
The product consists of one 1.5 mg pill of the synthetic hormone levonorgestrel and reduces the risk of pregnancy principally by suppressing ovulation or preventing fertilization. To be most effective it must be taken as soon as possible after sexual intercourse, preferably no more than 24 hours later, although it may still be effective if taken within 72 hours.
Groups arguing for easier access to such emergency contraceptives say that lifting current restrictions on these drugs would make it much more likely that they would be used when they could be most effective.
Anti-abortion groups, however, have long opposed approval of the products, arguing that the drugs also prevented implantation of a fertilized egg, essentially acting as abortifacients, a claim that has been challenged by the manufacturers and independent researchers.
Opponents have also expressed concerns that making emergency contraceptives available to younger women without a prescription undermined parental authority, encouraged underage sexual activity, and put young women at risk of sexually transmitted infections.
In 2011the Obama administration sided with opponents of easier access and ordered the FDA to maintain the age restrictions.
The FDA commissioner, Margaret Hamburg, wrote in a memorandum to the US health and human services secretary, Kathleen Sebelius, “It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages.”
But in response to a lawsuit the US District Court judge Edward R Korman in Brooklyn, New York, ordered in April that the restrictions should be lifted, finding that politics, not science, had guided the government’s decision making process.
In his opinion Korman lambasted Sebelius for forcing the FDA “to ride roughshod over the policies and practices” the agency used to consider changes in drug approvals.
The FDA said that it made the decision to relax restrictions on Plan B One-Step not in response to the judge’s ruling but on the basis of data submitted by the drug’s manufacturer, Teva Women’s Health of North Wales, Pennsylvania.
The company’s data showed that women aged 15 years or older understood that the product was not for routine use and would not protect them against sexually transmitted infections, the FDA said.
The US Department of Justice, however, has filed a notice with Judge Korman that it intends to appeal his ruling and has asked him for a stay, pending the outcome of the appeal.
Cite this as: BMJ 2013;346:f2909