U.S. to Defend Age Limits on Morning-After Pill Sales
- 05/02/2013 by PAM BELLUCK and MICHAEL D. SHEAR (NY Times)

The Obama administration moved Wednesday to keep girls under 15 from having over-the-counter access to morning-after pills, as the Justice Department filed a notice to appeal a judge’s order that would make the drug available without a prescription for girls and women of all ages.

The appeal reaffirms an election-year decision by Mr. Obama’s administration to block the drug’s maker from selling it without a prescription or consideration of age, and puts the White House back into the politically charged issue of access to emergency contraception.

The Justice Department’s decision to appeal is in line with the views of dozens of conservative, anti-abortion groups who do not want contraceptives made available to young girls. But the decision was criticized by advocates for women’s reproductive health and abortion rights who cite years of scientific research saying the drug is safe and effective for all ages.

“Age barriers to emergency contraception are not supported by science, and they should be eliminated,” Cecile Richards, the president of Planned Parenthood Federation of America, said in a statement on Wednesday.

In December 2011 the secretary of health and human services, Kathleen Sebelius, blocked the sale of the drug to young girls without a prescription, saying there was not enough data to prove it would be safe. In doing so, Ms. Sebelius took the unprecedented step of overruling the Food and Drug Administration, which had moved, based on scientific research, to lift all age restrictions.

Last month, Judge Edward R. Korman of United States District Court for the Eastern District of New York criticized that decision as overtly political and ordered the administration to make the contraceptive widely available. The Justice Department’s appeal will not say at what age girls should have access to over-the-counter morning-after pill.

Instead, it will contend that Judge Korman did not have the authority to order the F.D.A. to take a specific action and should have sent the issue back to the agency for further action. And it will say the judge did not have the right to extend his order to versions of the pill not included in the lawsuit.

The decision to appeal is striking in part because, before Ms. Sebelius overruled it in 2011, the F.D.A. — the Justice Department’s client in this case — had moved to do exactly what Judge Korman ordered last month.

“We aren’t focused in this appeal on the merits of the secretary’s decision,” said a Justice Department official, who spoke on condition of anonymity. “What we’re focused on is that the remedies that the judge ordered were beyond his authority.”

For Mr. Obama’s administration, the decision to appeal the judge’s ruling provides an opportunity to reaffirm a moderate position in the broader abortion debate that had drawn praise from conservative groups that are normally highly critical of the president.

The appeal also reinforces Ms. Sebelius’s original 2011 decision, which proved to be very good politics for Mr. Obama at the time. Facing a difficult re-election battle, the Democratic president enthusiastically supported Ms. Sebelius, saying that as a father of two young daughters, he thought it was the right call to have made.

“And I think most parents would probably feel the same way,” he added.

Wednesday’s announcement came a day after the F.D.A. said one well-known morning-after pill, Plan B One-Step, would be made available without a prescription for girls as young as 15 — instead of only to girls ages 17 and over, as has been the case. That decision also will make the drugs more accessible by putting them on the shelves with other over-the-counter medications.

The Justice Department’s action will not affect that F.D.A. decision. Instead, the department is seeking to overturn a much broader order by the judge that removed restrictions for all ages and for generic versions of the pill, not just Plan B One-Step. The order, issued on April 5 by Judge Korman, gave the F.D.A. 30 days to comply.

On Wednesday, the Justice Department also asked Judge Korman to stay his order pending the results of the appeal.

In his ruling, Judge Korman said the Obama administration had put politics before science in restricting access to the drug. At the time, Ms. Sebelius said the pill had not been studied for safety in girls as young as 11. But advocates on both sides of the highly divisive issue of emergency contraception interpreted her decision in a political context, particularly since it fell during a presidential campaign cycle.

In 2011, a decision to allow distribution of emergency contraceptives to very young girls might have sparked a firestorm of criticism from anti-abortion groups. And it might have made it more difficult for the president, politically, when it came to other battles over contraception, including an effort to require some religious institutions to provide contraception free of charge.

By appealing the judge’s ruling, Mr. Obama’s Justice Department is essentially renewing the objections that Ms. Sebelius — backed by the president — had more than a year ago. In recent weeks, conservative groups had urged the Justice Department to appeal the judge’s ruling so that the contraception would not be available to very young girls.

On Wednesday, a Justice Department official said the appeal would concentrate on the two areas where the department believes the judge overstepped his legal authority. The official also said the White House had not been involved in the decision of whether to appeal Judge Korman’s ruling.

“This is a decision that the Justice Department is making in representing our client: F.D.A.,” the official said. “This is not a political decision. It’s not had White House intervention or involvement. This in our judgment is the right legal step to take in this case.”

Officials at the White House declined to comment on Wednesday, referring all calls to the Justice Department. A spokesman for Ms. Sebelius also referred questions to Justice, saying it was an “ongoing legal matter.”

The Justice Department official said the lawsuit before Judge Korman referred only to Plan B, the earliest morning-after pill, which is a two-pill dose of a drug called levonorgestrel. There are also two generic versions of Plan B.

And there is a newer single-pill version, called Plan B One-Step, which is the product that the F.D.A. this week made available over the counter to girls as young as 15. While scientists say the one- and two-pill versions are essentially identical, the Justice Department official said its appeal was not just a semantic matter.

“It is a deeply held belief on the part of F.D.A., when two different drugs are at issue, that F.D.A. has to keep those two different drugs separate,” the official said.

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