Reprinted from Pharmalive.com
In a scathing decision, a federal judge criticized the Obama administration for a “frivolous” stalling tactic to defend age restrictions for the morning after birth control pill. And so, US District Court Judge Edward Korman refused to suspend a ruling he issued last month that ordered the FDA to make the morning after contraceptive pill available on an over-the-counter basis to girls of all ages (back story).
But at the same time, Korman postponed enforcement until Monday to give the agency time to file an appeal. The ruling was not surprising, given that Korman had previously accused the Obama administration of imposing “impermissible political and ideological considerations” on the ability of the FDA to make the Plan B pill available to girls and women of all ages without a prescription.
In December 2011, the White House blocked the agency from allowing the pill to become more widely available prior to the most recent Presidential election, prompting charges the administration was trying to appease conservatives and, in doing so, placed politics ahead of science. Some believe that Plan B prevents a fertilized egg from implanting in the womb, which some equate with abortion (read more here).
However, Korman accused the White House of acting in “bad faith,” causing “intolerable delays,” engaging in “political interference” and allowing the FDA to exercise an “administrative agency filibuster.” Up until that point, the controversial pill was available without a prescription only to women who are 17 years of age and older.
Two weeks ago, though, the FDA approved the use of the newer Plan B One-Step, which involves ingesting only one pill, for girls who are 15 years of age and older without a prescription. The FDA maintained the decision was made in response to an amended request by Teva Pharmaceuticals shortly after the December 2011 rejection to loosen distribution (see this).
In rejecting the government arguments, Korman attempted to box the Obama administration into a corner, by reiterating a statement issued by FDA commish Margaret Hamburg in December 2011. At the time, she said “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 non-prescription use for all females of child-bearing potential.”
He then pointed out that if he were to reject the FDA request to stay, or postpone, or his order, “the public can have confidence that the FDA’s judgment is being vindicated.” But if he grants the request for a stay, “it will allow the bad faith, politically motivated decision of (US Secretary of Health & Human Services Kathleen Sebelius), who lacks any medical or scientific expertise, to prevail, thus justifiably undermining the public’s confidence in the drug approval process." And he again called her December 2011 decision "so unpersuasive as to call into question her good faith" (HERE IS HIS RULING).
HERE IS THE TRANSCRIPT FROM THE RECENT HEARING
He also criticized the White House for arguing that a stay is needed to avoid the possibility of confusion among women and girls if a stay is not ordered, Korman criticized the FDA for instituting “nonsensical rules” and a “convoluted, triple-tiered marketing scheme that will only increase the confusion that already prevents women from obtaining timely access to emergency contraceptives.”
To wit, women who are 15 years or older can only obtain Plan B One-Step from stores with on-site pharmacies and must have government-issued proof of age; other pills with the same active ingredients will remain behind counters and only available to those 17 or older with proof of age, and women who lack proof of age or are under 15 will need a prescription for another pill with the same ingredient.
He then chastised the Obama administration for failing to note that many women do not live near stores with on-site pharmacies and that many such pharmacies are not open at all hours, which would continue to “present barriers to all women” who would seek contraception on a timely basis. Korman also noted that for the pills to be effective, they should be taken as soon as possible.
He then cited a research letter published last year in the Journal of the American Medical Association that pointed out of 942 pharmacies called in a survey of emergency contraceptive availability in five geographically diverse cites, only 4.7 percent were open 24 hours. “The difference between the hours of the pharmacy and the store itself is often significant,” Korman wrote.
He also noted that requiring government-issued photo identification is another difficult hurdle, since 15-year-old girls would not have a driver’s license and many would not have a driver’s permit, depending upon the state in which they live. And Korman cited a 2006 study by the Brennan Center for Justice that found many African-Americans earning less than $35,000 a year do not have such identification.
Korman also criticized the recent FDA approval by noting that girls who are younger than 15 – who would be required to have a prescription – cannot be expected to benefit from the latest arrangement, because they will need to visit a doctor to obtain a prescription. And he again noted that such a requirement takes time that can negate the benefit of the pill.
“President Obama is seeking to sacrifice the reproductive rights of women of all ages at the altar of his political strategy,” Mara Verheyden-Hilliard, executive director of the Partnership for Civil Justice Fund, which represented the plaintiffs. “He wants to placate the political right wing at the expense of the health needs and reproductive rights of women. It is as plain as day that the Obama administration has used deception and distraction as a tactic to avoid complying with the court order to make the Morning After Pill available without age restriction or identification barriers.”