PHARMACY ACCESS TO EMERGENCY CONTRACEPTION (EC)
In 2006, after three years of stalling, the U.S. Food and Drug Administration (FDA) finally approved over-the-counter access to the emergency contraceptive Plan BA for individuals age 18 and older. Emergency contraception, also known as the "morning-after" pill, can substantially reduce a woman's chance of becoming pregnant after unprotected sex. In 2009, the FDA approved Plan BA, and its generic equivalent Next ChoiceA, for over-the-counter (OTC) use for individuals age 17 and over.
In 2010, the FDA approved the emergency contraceptive ellaA, which is safe and effective for use up to five days (120 hours) after sex. ellaA is available only by prescription.
In 2011, Teva, the manufacturer of Plan BA and the one-dose version, Plan B One-StepA, filed an application with the FDA requesting that the contraceptives be made available OTC for individuals of all ages. Unfortunately, in December 2011, the Department of Health and Human Services (HHS) announced that, despite FDA's recommendation to the contrary, it would not lift the age restriction on the medications Plan BA and Plan B One-StepA.
In February 2012, advocates who had previously filed suit against the FDA's age restrictions reopened the case and added HHS Secretary Kathleen Sebelius as a defendant. In April 2013, a federal judge ruled that HHS and FDA must lift all age or point-of-sale restrictions placed on levonorgestrel-based EC and make the medication available OTC. The judge added that Secretary Sebelius' decision to overrule the FDA's recommendation was "politically motivated, scientifically unjustified, and contrary to agency precedent." Also in April 2013, HHS announced that it had approved an amended application from Teva, thereby lowering the age restriction on this particular type of EC to those younger than 15. The medication would be allowed to be on the shelf, but would include a "proof of age" requirement to be triggered at the cash register. Additionally, the medication would only be sold on the shelf at stores that include a retail pharmacy.
The very next day, the Department of Justice (DOJ) filed an appeal to challenge the court decision. The judge in the case refused to grant DOJ a stay, stating that the appeal "is frivolous and is taken for the purpose of delay." However, he did allow DOJ to seek a stay from the court of appeals before the order went into effect. DOJ appealed the decision and a federal appeals court temporarily granted a stay. Before a decision was handed down, however, the Obama administration dropped its appeal. With that decision, Teva and the FDA reached a compromise that Plan B One-StepA would be available OTC without an age restriction. To confuse the matter further, an age restriction of 16 years and younger remains in place for all other brands of EC.