Government: No promises on “Plan B” (UPDATED)
on May 13, 2013 at 5:07 pm
UPDATED 6:05 pm. The Second Circuit Court said Monday it will submit the government’s request to a motions panel on May 28. In the meantime, the judge’s order on unlimited access for all ages will remain on hold. There is no timetable for the Circuit Court panel to act.
—————-
Saying it cannot say at this point whether it would ever allow younger girls to get access to an emergency contraceptive, the Obama administration on Monday asked the Second Circuit Court to block a federal judge’s order to make the drug available to all women of any age, without prescriptions. The government’s motion, in Circuit docket 13-1690, can be read here.
If the Circuit Court approves the request, the one-pill version of so-called “Plan B” will be available without prescription to women who are fifteen years old or older, but only if they can prove their age with a government-issued form of ID. For younger girls, they will need a doctor’s prescription, and will be able to get the drug only at a pharmacy.
At issue in Monday’s filing was a ruling by Senior U.S. District Judge Edward R. Korman of Brooklyn, N.Y., that the Food and Drug Administration must lift all restrictions on access to either the one-pill version of Plan B, or the earlier, two-pill version. The one-pill version now accounts for about eighty-five percent of sales of the drug.
The administration complained to the Second Circuit that, at most, Judge Korman should have sent the issue back to the FDA, for it to go through a normal review process to switch Plan B from a prescription drug to over-the-counter access, and what conditions, if any, should be imposed on its availability. The FDA cannot know in advance how such a review would occur, the motion argued.
The motion also suggested that, if the dispute were returned to the FDA, the Secretary of Health and Human Services, Kathleen Sebelius, would still have a role in deciding on further availability of the drug. Judge Korman in recent rulings has been sharply critical of Sebelius, for vetoing full access to Plan B for what the judge said were political reasons. Moreover, the judge said flatly, Congress gave to FDA, without any role for the Secretary herself, the role of deciding as an expert agency how drugs should be marketed.
Monday’s motion said pointedly that, if the access issue were returned to the FDA, the head of FDA along with Secretary Sebelius “will consider” any new information that is submitted on that question. “There is no basis for assuming in advance the conclusions of the agency or the Secretary,” the filing said. That appeared to be a direct retort to Judge Korman’s conclusion that federal drug law gives no role whatsoever to the HHS chief in the drug access process.
As expected, the government’s motion made two legal criticisms of Judge Korman’s action: first, that he assumed the authority to act on access to both the one-pill and two-pill versions, when only the two-pill version was actually before him in the test case, and, second, that he directly ordered unlimited access to the drug rather than returning the issue to FDA for another look.
It is unclear when the Second Circuit will act on the motion. The challengers to the FDA’s refusal to lift all restrictions on access, for all ages, said they plan to file a response within ten days.
