April 17, 2013
With Court Ruling, ‘Morning-After Pills’ May Move to Drugstore Aisles
Central Islip, NY—Will pharmacies soon be stocking Plan B emergency contraceptive pills in their regular aisles?
That could happen according to whether a recent federal court ruling stands.
U.S. District Judge Edward Korman of the Eastern District of New York, based in Central Islip, ruled that the Obama administration’s decision to limit access to Plan B was arbitrary and unreasonable. The 59-page opinion overturned a decision by Health and Human Services Secretary Kathleen Sebelius to restrict access to the so-called morning after pill, only allowing it to be dispensed to those 17 or older.
In making her decision, Sebelius blocked an FDA decision to allow unrestricted access to Plan B, noting “significant cognitive and behavioral differences” between older adolescents and “the youngest girls of reproductive age.” The FDA action was in response to a request by Teva Pharmaceutical Industries, which had sought unrestricted access for the drug.
President Obama supported Sebelius’ decision, according to Jay Carney, White House press secretary. “He believed it was a common-sense approach when it comes to Plan B and its availability over the counter to girls under, I believe, 17, and he believed that was a sensible approach,” Carney said at a press briefing.
Because of the HHS requirement, the drug has been kept behind the counter and dispensed by pharmacists with proof of age.
Noting that the drug is already available to younger girls with a prescription, Korman ruled, “The invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”
While acknowledging the controversial nature of the case because “it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs,” the judge said the HHS decision caused the FDA “to ride roughshod over the policies and practices that it has consistently applied” when deciding whether to grant a drug over-the-counter status. FDA was ordered to make the pill available without a prescription or age restrictions within 30 days.
That could be delayed, however, if the Obama administration appeals the ruling.
Plan B uses high doses of the female hormone progestin to block a potentially fertilized egg from becoming implanted in a woman’s uterus and is considered effective within 3 days after sexual intercourse.
In unusual solidarity with the Obama administration, the conservative Family Research Council expressed concern that the court went against Sebelius’ decision.
“This ruling places the health of young girls at risk,” said Anna Higgins, JD, speaking for the council. “Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment. I am very troubled that the court has not fully taken into account the concerns expressed by HHS Secretary Kathleen Sebelius and many public health advocates that there is not enough data on the health effects of Plan B on young girls.”
Her statement also noted that parental involvement as well as the required role of pharmacists and other medical professionals provides a “safeguard for these young girls. However, today’s ruling removes these commonsense protections.”
|U.S. Pharmacist Social Connect