Judge Escalates Battle with Obama Administration over Morning-After Pill

Monday, May 13, 2013
Judge Edward Korman

Calling the Obama administration's arguments “frivolous,” “silly,” “out of an alternative reality” and evidence of “bad faith,” federal Judge Edward R. Korman last week denied a request from Justice Department lawyers that he stay his April 5 order expanding access to emergency contraception to all women and girls old enough to get pregnant and rejected a “compromise rule” offered by the government.

 

At issue is the contraceptive medication Levonorgestrel, a synthetic hormone formerly marketed as “Plan B” and now sold in generic versions. If taken soon after intercourse (ideally within 24 hours), it prevents fertilization and hence pregnancy. Available by prescription since 1999, and over-the-counter (OTC) for 17-year-olds since 2009, in December 2011 an FDA expert panel approved Levonorgestrel for OTC availability to “all females of child-bearing potential.”

 

Health and Human Services (HHS) Secretary Kathleen Sebelius quickly overturned that decision—the first time in history that an HHS Secretary struck down such a recommendation—by re-instating the minimum age of seventeen. Although Sebelius claimed she based her veto decision on science because of a lack of studies of the drug’s safety for girls as young as 11, her veto was widely seen as a political decision made less than a year before the 2012 elections.

 

It was that decision Judge Korman struck down on April 5, calling it “arbitrary, capricious and unreasonable.” 

 

In light of Judge Korman’s April 5 order, the FDA last week proposed a compromise rule allowing women and girls 15 and older to buy the drug without a prescription and asked for a stay of Korman’s order. Instead, Judge Korman rejected the compromise rule as politically motivated and meant to “sugarcoat” the government’s appeal, but just as fatally unsupported by science as Sebelius’s veto decision.  

 

Using unusually strong language, Judge Korman predicted that “If a stay is granted, it will allow the bad-faith, politically motivated decision of Secretary Sebelius, who lacks any medical or scientific expertise, to prevail—thus justifiably undermining the public’s confidence in the drug approval process.” Government attorneys were understandably tight-lipped in their public comments, making none.

 

Korman also ridiculed government arguments that allowing full OTC access while the case moves forward in the courts would cause “uncertainty” and “confusion” for women, writing that “this silly argument ignores the fact it is the government’s appeal from the order that sustained the judgment of the commissioner of the FDA that is the cause of any uncertainty, and that that appeal is taken solely to vindicate the improper conduct of the secretary and possibly for the purpose of further delaying greater access to emergency contraceptives for purely political reasons.” He characterized the contention that women will be confused “largely an insult to the intelligence of women.”

 

Despite the vigor of his language, Judge Korman postponed enforcement of his order until Monday to allow government lawyers to go to the appeals court with their request for a stay.

-Matt Bewig

 

To Learn More:

Judge Refuses to Drop His Order Allowing Morning-After Pill for All Ages (by Michael D. Shear, New York Times)

Judge blasts Obama administration request for a stay to his Plan B as ‘alternative reality’ (by Megan Carpentier, Raw Story)

Obama Administration Seeks Compromise in Heated Emergency Contraceptive Debate (by Noel Brinkerhoff and Aaron Wallechinsky, AllGov)

Judge Slams FDA for Delaying Emergency Contraception to Girls under 17 (by Matt Bewig, AllGov)

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