Judge refuses to back down on “Plan B”
on May 10, 2013 at 2:05 pm
A federal judge in New York, in a blistering new denunciation of the Obama administration for what he said was playing politics with women’s health, refused on Friday to lift his order that the Plan B emergency contraceptive be made available over the counter to women of all ages. He did give the government until Monday to start pursuing an appeal to the Second Circuit Court, but criticized that appeal as “frivolous.”
Senior U.S. District Judge Edward R. Korman of Brooklyn aimed most of his harsh critique at Secretary of Health and Human Services Kathleen Sebelius, saying once again that she has abused her position and has frustrated women’s access to Plan B even though the government’s own scientists say it is safe and effective in preventing pregnancy if taken soon after unprotected intercourse. He derided the arguments that the Justice Department plans to make in its appeal, saying that Sebelius herself has undercut those arguments. One argument, he said, was “silly.”
Korman went even further, accusing the administration of making a “sweetheart arrangement” with the company that makes Plan B pills, negotiated one day before the government filed a formal notice that it would appeal, lowering the age of no-prescription action to the contraceptive from seventeen to fifteen. That deal was worked out, the judge asserted, to “provide a sugarcoating” for the appeal the government was planning. The government waited as long as it could to respond to the judge’s April 5 order requiring broader access to the drug, the judge said.
Under that arrangement, Korman said, the Plan B maker — Teva Women’s Health, Inc. — stands to gain a commercial advantage in selling the contraceptive, and women may find it harder to obtain the drug than they would have under the judge’s order. Women will have to prove their age to a pharmacist or drugstore retail clerk to obtain Plan B, under the Food and Drug Administration’s new arrangement.
The Justice Department told the judge last week that it would challenge his order with two legal arguments: first, that the judge had no authority to order open access to the one-pill version of Plan B (known as Plan B One-Step) because the two-pill version was the only one at issue before him; and, second, that his order intruded on the FDA’s normal process of reviewing when to switch a prescription drug to over-the-counter status.
Judge Korman sought to answer both arguments on the way toward suggesting that the appeal on those grounds would be “frivolous.” He said the issue of which pill version was before him was no longer an issue, because Teva — instead of taking advantage of the wider access that the judge ordered — had made its new deal with the FDA to restrict access to any version to those fifteen years old and older. That issue, he said, is probably moot now.
The judge rejected the argument that he was infringing on FDA’s expertise by issuing a specific order on over-the-counter access. That is precisely what the experts at FDA had wanted, before Secretary Sebelius overruled them, the judge said, so it was the Secretary who engaged in “undermining the public’s confidence in the drug approval process.” Sebelius, he remarked sharply, made a “bad-faith, politically motivated decision,” and she “lacks any medical or scientific expertise.”
By refusing to delay his own order as the government asked, the judge said, he was vindicating FDA’s expert judgment that Plan B should be available without a prescription and over the counter to women of all ages.
To a separate argument by Justice Department lawyers that the judge’s access order will only lead to public confusion about which contraceptive is available to women, Judge Korman replied that it is the new arrangement made with Teva that is going to result in confusion. The judge ticked off the multi-layered system of access that would result from the arrangement FDA has just made with Teva.
It was “nonsensical,” the judge said, to work out that arrangement: first, women fifteen years of age or older will be allowed to buy the one-pill version, but only from a store with an on-site pharmacy and only if they can prove their age; second, other versions of the contraceptive with the same basic ingredient as Teva’s Plan B will only be available from behind the counter and only for women over the age of seventeen who can prove their age with a government-issued ID; and, third, women who do not have a government ID or who are under the age of fifteen will not have any access to Teva’s one-pill version and must get a prescription for a competing product, such as a generic version.
This system is sure to cause confusion, much more than the judge’s order on wide access, he said.
While he denied the requested postponement of his order pending an appeal, he said he would not implement his order over the weekend, giving the Justice Department until noon Monday to file a request for a delay with the Second Circuit Court.
