Judge, FDA At Loggerheads Over Emergency Contraceptive Pill (Plan B) Ruling

Senior United States District Judge Edward R. Korman has just ruled that the morning-after levonorgestrel-based emergency contraceptive pill should be within the reach of any woman in the U.S., without a need for a doctor's prescription.

In the process, Judge Korman has run into trouble with the Obama Administration over contraception. Instead of acceding to the request from the Justice Department for suspension of his April 5, 2013 order pending an appeal on behalf of the Food and Drug Administration (FDA), Judge Korman, of the Eastern District of New York, accused the government of political interference and bad faith.

He finds fault with the Secretary of Health and Human Services Kathleen Sebelius as the cause of the rejection of over-the-counter sale of levonorgestrel-based emergency contraceptives. In 2011, Sebelius allowed the sale of such drugs  without a  prescription only to women 17 years and older, and currently to all women 15 years and older.

The case Tummino v. Hamburg, --- F. Supp. 2d ----, 2013 WL 1348656 (E.D.N.Y. Apr. 5, 2013) involves Plan B and Plan B One-Step, emergency contraceptives that are indicated to reduce the risk of pregnancy after unprotected intercourse. They "must be taken as soon as possible after unprotected intercourse. The longer the delay, the less effective they become. The effort to convert these levonorgestrel-based contraceptives from prescription to over-the-counter status has gone on for over twelve years, even though they would be among the safest drugs available to children and adults on any drugstore shelf," according to Judge Korman's introductory remarks in his order.

If Judge Korman's order sees the light of the day, any young girl can potentially access the morning-after pill over-the-counter, without a doctor's order (prescription), contrary to the Obama Administration's policy, but in tune with what FDA's position was before Sebelius intervened in 2011.

At a hearing last week, Judge Korman said that the government's decision was politically motivated and indicated he believed the drug should be made more widely available.

"The Secretary's action was politically motivated, scientifically unjustified, and contrary to agency precedent, and because
it could not provide a basis to sustain the denial of the Citizen Petition," Korman wrote.

In his ruling, the judge accused Secretary Sebelius of blocking the drug's wide availability without the legal authority to do so. And he scoffed at the Justice Department lawyers for citing her legal authority as a reason for their appeal of his ruling.

"In something out of an alternate reality, the defendants seek a stay to pursue an appeal that would vindicate the secretary's disregard of the very principle they advocate," Judge Korman wrote. However, "as a courtesy to the Court of Appeals, and to enable it to schedule the motion in the ordinary course," the judge granted "a stay pending the hearing or submission of the defendants' motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013."

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