“….I do not dwell on this aspect of the prejudice suffered by the population of the youngest adolescents, although it should not be ignored, because the number of these adolescents who actually use levonorgestrel-based emergency contraceptives is miniscule, and they have been invoked in the debate over access to these contraceptives mostly as a red herring to justify the continued burdens suffered by older women who seek access to the drug….”
On Friday Judge Edward Korman of the United States District Court for the Eastern District of New York rejected the administration’s request for a stay while they appeal his ruling on lifting restrictions on the the availability of Plan B contraception.
The language is scathing:
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
ANNIE TUMMINO, et al.,
– against –
MARGARET HAMBURG, Commissioner
of Food and Drugs, et al.
MEMORANDUM & ORDER
No. 12-CV-763 (ERK)(VVP)
….This salutary principle was flagrantly violated by Secretary Sebelius, who completely lacks the “necessary information and scientific expertise to assess the data and information required to make a determination that a drug is safe and effective,” and whose role in the process has been circumscribed by Congress as well as by the delegation to the Commissioner of any authority that the Secretary may have-a clear recognition by Congress and the Secretary of her lack of competence in this area. See Tummino v. Hamburg, 2013 WL 1348656 at *21. Yet, 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….
And, living in the real world:
….Moreover, while there are some retail establishments that are open for longer hours than their pharmacy counters, the unjustifiable point-of-sale restrictions left in place under the Teva-FDA agreement will continue to present barriers to all women. Many women do not live near a store with an on-site pharmacy, and even when the drugstore or comparable facility has an on-site pharmacy, the difference between the hours of the pharmacy and the store itself is often significant. Indeed, a research letter published in the journal of the American Medical Association found that “of the 943 pharmacies called” in a survey of emergency contraceptive availability in five geographically diverse cities, “only 4.7% were open 24 hours.” Tracey A. Wilkinson et al., Research Letter: Access to Emergency Contraception for Adolescents, 307 J. Am. Med. Ass’n 362 (January 25, 2012)….
As anyone who lives in the real world can tell you, a twenty-four hour store with a pharmacy doesn’t necessarily have a twenty-four hour pharmacy. And that can depend on where you live. There’s a significant difference in availability from “on the shelf” to “behind the counter and you have to ask for it and present ID”.
And, further, the administration’s motivation for opposing availability of Plan B contraception gets attention:
….This argument ignores the fact that the FDA found that the drug was safe and could be used properly without a doctor’s prescription, and was prepared to make it available over-the-counter for all ages. As Commissioner Hamburg observed, “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.” Statement from FDA Commissioner Margaret Hamburg, M.D., on Plan B One-Step (Dec. 7, 2011). Thus, if a stay is denied, the public can have confidence that the FDA’s judgment is being vindicated, and 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….
And, even more smack down of the administration:
….Nor is there any merit to the related argument that a stay will “prevent public uncertainty regarding the status of the drugs at issue here pending the government’s appeal to the Second Circuit.” Defs.’ Br. at 13. 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. Whether my order is stayed or not will not resolve any uncertainty….
And, the “I can’t believe anyone with a grandmother, mother, sister, or daughter wrote that” quote:
….The defendants also argue that “if the status of these drugs is changed and later reversed, it can lead to situations in which women mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be available, but is no longer.” Defs.’ Br. at 13. This argument assumes that defendants have a likelihood of success on the merits, an issue that I will shortly address, and is largely an insult to the intelligence of women….
This is not a happy judge:
….On remand, defendants engaged in the same bad faith that resulted in my initial remand. They delayed the decision for three years and, ultimately, improper political influence prevented the FDA from granting the petition. Nor do they claim a reasonable probability of success on appeal in challenging my analysis of their flagrant misconduct….
And, the final say:
….The motion for a stay pending the appeal is denied. Indeed, in my view, the defendants’ appeal is frivolous and is taken for the purpose of delay. Nevertheless, as a courtesy to the Court of Appeals, and to enable it to schedule the motion in the ordinary course, I grant 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….
This will be interesting.