A federal judge rejected as “frivolous” a government request to delay the effect of his order giving girls including those 16 and younger access to the so-called morning after-pill without a prescription.
U.S. District Judge Edward R. Korman in Brooklyn, New York, refused today to put the ruling on hold while the government appeals his decision that the emergency contraceptive doesn’t require a prescription. He gave officials until May 13 to seek a delay from the U.S. Court of Appeals in New York.
“Significantly, defendants do not take any issue with any of my substantive conclusions,” Korman wrote. “In my view, the defendants’ appeal is frivolous and is taken for the purpose of delay.”
The U.S. Food and Drug Administration in December 2011 was set to approve sales of Teva Pharmaceutical Industries Ltd.’s (TEVA) Plan B One-Step, a branded version of the pill, without a prescription. Health and Human Services Secretary Kathleen Sebelius overruled the action, marking the first time an FDA decision was reversed by a presidential administration.
Korman last month ordered the FDA to lift age restrictions for obtaining levonorgestrel-based contraceptives without a prescription and said the agency was influenced by political pressure. The government is appealing.
F. Franklin Amanat, a government lawyer, declined to comment on the order today and said the Justice Department is evaluating its next steps.
In his order today, Korman called Sebelius’s action “politically motivated, scientifically unjustified, and contrary to agency precedent.”
Referencing a December 2011 memorandum, Korman noted that FDA Commissioner Margaret Hamburg had said “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
Sebelius said at the time that her decision to overrule Hamburg was merited by “cognitive and behavioral” differences in girls of the youngest reproductive age.
Currently, the FDA allows women 17 and older to obtain generic and non-generic versions of the morning-after pill without a prescription. Last month, the agency approved Teva’s application to sell its branded pill Plan B One-Step over-the-counter to girls as young as 15, saying the move was “independent” of the court case.
At a hearing earlier this week, Korman said the approval of Teva’s application offered little additional benefit to women because they would still be subject to age restrictions, requiring photo identification that younger and poorer women might not possess.
Younger teens lacking prescriptions would also only be able to obtain Teva’s more expensive branded drug, costing as much as $60 per dose, rather than generics, Korman said during the hearing.
The contraceptive, which contains a larger dose of the hormone levonorgestrel than found in other birth control pills, prevents pregnancy by inhibiting fertilization. The drugs are most effective when taken within 24 hours of intercourse.
Anti-abortion groups have alleged that the pill can kill embryos by preventing implantation. In April, Charmaine Yoest of Americans United for Life called the pill “a potent and potentially life-ending drug” that young girls should need medical supervision to take.
Korman said in his ruling today that the government has already put off making the contraception more widely available for too long and acted in “bad faith” in past initiatives to do so.
“The effort to convert these levonorgestrel-based contraceptives from prescription to over-the-counter status has gone on for over 12 years, even though they would be among the safest drugs available to children and adults on any drugstore shelf,” Korman said in the ruling. The FDA “delayed as long as it possibly could before it took even one incremental step in the process.”
The case is Tummino v. Hamburg, 12-cv-00763, U.S. District Court, Eastern District of New York (Brooklyn). The appeal is Tummino v. Hamburg, 13-1690, U.S. Court of Appeals for the Second Circuit (Manhattan).
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