A decade-long heated debate regarding the availability of the morning after pill, Plan B One-Step, to all without prescription is now over. On April 5, a federal judge ruled that that the government must make the emergency contraceptive available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. In his ruling, Edward R. Korman of Federal District Court, also accused the federal government of “bad faith” in dealing with the requests to make the pill universally available, and said its actions had been politically motivated. He ruled that the government’s refusal to lift restrictions on access to the pill was “arbitrary, capricious, and unreasonable.”
Judge Korman ordered the F.D.A. to lift any age and sale restrictions on the pill, Plan B One-Step, and its generic versions, within 30 days. The decision thwarts an unprecedented move by the Obama administration’s Health and Human Services secretary, Kathleen Sebelius, who in 2011 overruled a recommendation by the Food and Drug Administration (FDA) to make the pill available for all ages without a prescription. The judge wrote: “More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced. The F.D.A. has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.” He added, “The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.”
After the ruling was announced, the FDA and the Department of Health and Human Services declined to comment on the ruling or the judge’s harsh criticisms or to indicate whether the government would file an appeal; however, they did note that the decision was being reviewed. “The Department of Justice is reviewing the appellate options and expects to act promptly,” noted Allison Price, a department spokeswoman.
For years, healthcare professionals, including those at the F.D.A., have been recommending unrestricted access for years; in addition, major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics supported unrestricted access to the morning after pill. The organizations claim that the restrictions effectively keep many adolescents and younger teenagers from being able to use a safe drug in a timely way to prevent pregnancy, which carries greater safety risks than the morning after pill.
In 2011, F.D.A. commissioner, Dr. Margaret A. Hamburg, issued a statement saying that after rigorous study, it was safe to sell Plan B One-Step over the counter for all ages. However, she was overruled by Secretary Sebelius, the Health and Human Services secretary, the first time such a public countermanding had ever occurred. In her decision, Secretary Sebelius said that Plan B’s manufacturer had failed to study whether the drug was safe for girls as young as 11, about 10% of whom are physically able to bear children. However, her decision was viewed by many as a political move because emergency contraception has become an issue in the abortion debate and because allowing freer access to adolescents would prompt critics to accuse the Obama administration of supporting sexual activity for girls of that age. At the time, President Obama supported Secretary Sebelius’s decision, saying, “I will say this, as the father of two daughters: I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.” He added: “And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.”
Plan B was approved in 1999 as a prescription-only product; in 2001, the Center for Reproductive Rights filed a citizens’ petition for it to be made available over the counter or without a prescription. Healthcare professionals, including an expert advisory panel to the FDA, gave early support to that request. However, the FDA rejected the application because some officials expressed concern that they worried they would be fired if they approved it. The drug’s manufacturer, Teva Pharmaceuticals, declined to comment on the court decision. However, beginning in 2003, it had petitioned the FDA for Plan B to be available over the counter.
In 2006, the Bush administration allowed over-the-counter sales to women 18 and older; however, it required a prescription for those 17 and younger. Then in 2009, Judge Korman issued a ruling in the court case directing that the pill be made available over the counter for those 17 and older. In his 2009 ruling, the judge said the government’s actions on the pill had been driven by politics and not science.
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