Bombshell – Judge Rules Morning After Pill Should Be Available to All

Bombshell – Judge Rules Morning After Pill Should Be Available to All

April 5th, 2013 // 3:17 pm @

Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission

In what some are calling a landmark decision, a federal court judge has ruled that the morning after pill should be made available “without a prescription and without point-of-sale or age restrictions within thirty days.” The ruling follows more than a decade of contentious debate over access to the contraceptive, which is also known as Plan B and is currently available only to women age 17 and older without a prescription, but behind counters.

April 16 – cGMP Inspection Tips and War Stories – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, and 21 Tips and Tricks for Your Next Audit

The controversy over the pill has been characterized by fierce bickering over public policy issues that often pitted science versus politics. Some believe that Plan B and the newer Plan B One Step prevent a fertilized egg from implanting in the womb, and some equate this with abortion. Many doctors and pharmacists still refuse to provide the pill (see this). But US District Court Judge Edward Korman took the Obama administration to task for its handling of the issue, which began when several non-profit advocacy groups filed a citizen’s petition in 2001 asking for unrestricted over-the-counter status for women and girls of all ages.

Five years later, the FDA denied the petition and decided only women ages 17 and older would be able to buy the pill without a prescription, but not before the top FDA official in charge of women’s health issues resigned to protest against an agency decision to delay a final ruling on accessibility. The advocacy groups, however, pressed their fight by filing a lawsuit and, four years ago, Korman chastised the FDA for being “arbitrary and capricious,” making decisions in “bad faith” and being influenced by “impermissble political and ideological considerations” imposed by the Bush White House.

The scenario was largely repeated in late 2011, however, when the FDA was about to ease access and US Health & Human Services Secretary Kathleen Sebelius took the extraorindary step of overruling the move at the last minute. The FDA was willing to make the pill available in store aisles, which would have made it possible for younger teenage girls to purchase without assistance or a prescription (back stories here and here). But Sebelius maintained “the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.” The move prompted criticism of the Obama adminstration for pandering to conservatives during the run-up to the 2012 presidential election and politicizing the FDA.

The chain of events prompted Korman yesterday to again speak harshly of the Obama administration, pointedly accusing the White House of “bad faith,” “intolerable delays,” “political interference” and allowing the FDA to effectively exericse an “administrative agency filibuster.” In his 59-page order issued yesterday, he wrote that “the motivation for [Secretary Sebelius’] action was obviously political. … [I]t was an election year decision that ‘many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.’ ” He added that the administration offered arguments that were an “excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions” (HERE IS HIS RULING).

The advocacy groups expressed joy. “This decision is a welcome advance and affirms what feminists have been fighting for all along – the Morning-After Pill should be available to females of all ages, on the shelf at any convenience store, just like aspirin or condoms. Women and girls should have the absolute right to control our bodies without having to ask a doctor or a pharmacist for permission,” says Annie Tummino, the lead plaintiff and coordinator of National Women’s Liberation, in a statement.

Similarly, Andrea Costello, an attorney with the Partnership for Civil Justice Fund, which represents the NWL plaintiffs, says: “Women and girls have won a landmark victory today for reproductive justice,” said . “The denial of full access to the Morning-After Pill has been an outrageous political decision and wholly without scientific basis – under both the Bush and Obama Administrations. The court’s decision dramatically expands access to a safe and effective form of birth control and is a ruling in favor of science and for justice for women.”

An FDA spokeswoman writes us that this is an “ongoing legal matter for the agency and so we won’t have any comment.”


Subscribe Now

Featured Partner