US judge strikes down age restrictions for “morning after” contraceptivesBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2211 (Published 08 April 2013) Cite this as: BMJ 2013;346:f2211
A federal judge has ordered the US Food and Drug Administration (FDA) to make levonorgestrel based emergency contraceptives, the so called “morning after” pills, available over the counter without age restrictions.
Before the ruling, the FDA had approved sale of the contraceptives to women aged 17 years and older without prescription, but required those aged 16 and younger to obtain a prescription before they could purchase the drug.
The FDA approved the emergency contraceptive, Plan B, as a prescription drug in 1999. This formulation consisted of two pills containing 0.75 mg each of the synthetic hormone levonorgestrel, to be taken 12 hours apart after intercourse. A second formulation, Plan B One-Step consisting of one pill containing 1.5 mg of levonorgestrel, was approved in 2009.
According to current FDA labeling, the drug works principally by preventing ovulation or fertilization but may also inhibit implantation, a controversial claim that has been challenged by the manufacturer and independent researchers.
To be most effective, the contraceptives must be taken as soon as possible after intercourse, preferably no more than 24 hours later, although they might still be effective if taken within 72 hours.
In 2001, the Center for Reproductive Rights, an advocacy group, filed a citizen petition with the FDA on behalf of more than 70 medical and public health organizations to make Plan B available to all women without prescription.
The petition argued that the prescription requirement was medically unnecessary and prevented women from obtaining the drug when it could be most effective.
But political opposition to lifting the restrictions was fierce: opponents argued that making the drug available to young girls without prescription encouraged underage sexual activity, put them at risk for sexually transmitted infections, and undermined parental authority.
Anti-abortion groups also opposed use of the contraceptives, citing concerns that by blocking implantation of a fertilized egg, they were, in fact, abortifacients.
In his ruling, Judge Edward Korman criticized the FDA and US health secretary Kathleen Sebelius for allowing political considerations to take precedence over the science.
The case had proven to be controversial, he noted, because “it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs, and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs.”
“The standards are the same for aspirin and for contraceptives,” he wrote. “While the FDA properly recognizes that cognitive and behavioral differences undermine ‘the ability of adolescents to make reasoned decisions about engaging in sexual intercourse,’ the standard for determining whether contraceptives or any other drug should be available over the counter turns solely on the ability of the consumer to understand how to use the particular drug ‘safely and effectively.’”
Cite this as: BMJ 2013;346:f2211