On May 1st, the Justice Department (DOJ) filed notice that it will challenge the ruling of a federal court judge requiring the FDA to allow women of all ages to buy emergency contraception over the counter. This is just the latest event in the long history of the struggle over issues of access to the controversial drug.
Struggles Over Access to Emergency Contraception
Just the day before, the Food and Drug Administration (FDA) approved over-the-counter sales of emergency contraception to women 15 and older. This decision went into effect immediately, and is not affected by the recent actions of the DOJ.
Judge Edward Korman of the U.S. District Court of the Eastern District of New York ruled that the FDA must reverse a 2011 decision restricting access to emergency contraception, stating that it should be available over the counter to women of all ages. The April 5th ruling stated that the FDA had 30 days to comply. The DOJ is requesting a stay on this order.
Korman argued that the FDA’s decision to restrict access was not based on the science, which shows that the drug is safe for women of all ages, but was politically motivated. Nancy Northrup of the Center for Reproductive Rights supported Judge Korman’s position, stating that age and other point-of-sale restrictions were “unjustified and burdensome.”
Opponents are worried that with unrestricted access to emergency contraception, young teens might put themselves at risk by using it without the supervision and advice of a doctor or parent. Some pro-life groups oppose the drug altogether, likening it to an abortion. Others think that emergency contraception tacitly encourages unprotected sex.
Sidestepping these arguments, the DOJ stated that it filed notice because the court exceeded its authority by ordering the FDA to comply.
Plan B: From Prescription to Behind-the-Counter to Over-the-Counter
The drug, sold under the brand name Plan B and also known as “the morning-after pill,” contains the synthetic hormone levonorgestrel and works either by disrupting ovulation or by preventing fertilization of the egg. Plan B does not affect an egg that’s already fertilized. When used within 72 hours of unprotected sex, it reduces the likelihood of a resulting pregnancy.
Plan B was first approved by the FDA in July 1999 with a prescription. In August 2006, it became available behind the counter (that is, without a prescription, but only from a pharmacist) for adults over 18. A prescription was still required for girls under 18. Since March 2009, that nonprescription access became available for those 17 and over, maintaining the need for girls under 17 to have a prescription.
In 2011, the FDA decided to make Plan B available to younger teens, but Secretary Kathleen Sebelius of Health and Human Services overruled that decision, and the availability without prescription remained only for women 17 and older.
The April 30th ruling of this year by the FDA allowed Plan B One-Step to be sold over the counter to anyone over 15 with proof of age. Other kinds of emergency contraception – the two-pill Plan B and the generic form of Plan B – are still available from a pharmacist only. The ruling also gave marketing exclusivity for three years for Plan B One-Step to Teva Pharmaceutical Industries.
The Future of Emergency Contraception
The outcome of the DOJ’s challenge will be sure to anger people on one side of the debate or the other. The history of emergency contraception has been one of slow and steady increased accessibility for women, but this could be where that stops. Korman is expected to give his decision on whether to grant a stay in the next few days.
