FDA (finally) approves non-prescription access to Plan B for 17-year-olds

Apr 24, 2009 4:49 PM

The Food and Drug Administration announced this week that it would comply with a court order to make the emergency contraceptive levonorgestrel (Plan B) available to 17-year-olds without a prescription. The court order comes several years after the FDA approved adult over-the-counter use of the contraceptive, sometimes called the morning after pill.

The decision is a victory for evidence-based drug approval. In 2004 the FDA limited availability of Plan B for 17-year-olds to prescription only, despite evidence that it was safe and effective for that age group. A 2005 report by the non-partisan Government Accountability Office found the decision "unusual," and reported that the FDA’s then acting director "did not follow FDA’s traditional practices."

According to the court filing, the FDA argued that 18 was the appropriate cutoff point, because of the "difficulty of enforcing an age-based restriction." But the court called that position "implausible," and ruled that the denial of OTC status for plan B "runs counter to the evidence." The court also said the FDA should reconsider its decision for OTC use of Plan B for those under 17.

Our medical advisors believe this was the proper decision. Dr. John Santa, Director of Consumer Reports’ Health Ratings Center, says "women 17 and over deserve to have access to the personal health options they choose."

Plan B can prevent pregnancy in the event of a failure of traditional contraceptives, after unprotected sex, or after sexual assault. They contain higher levels of a common hormone used in oral contraceptives, and are not for routine use. Plan B is best taken as soon as possible after sex within 72 hours, and may work up to 5 days after sex. There are no serious, or long-term side effects, but it does have some short-term side effects similar to oral contraceptives, including nausea, headache, and stomach pain. It is only available behind the counter at pharmacies staffed with a licensed pharmacist.

—Kevin McCarthy, associate editor

We'd like to hear from you: Tell us what you think about the FDA's decision to make Plan B available to 17-year-olds without a prescription.