Reproductive rights groups sue FDA over EC

April 1, 2005

The Center for Reproductive Rights filed a lawsuit against the acting commissioner of the Food and Drug Administration in January for failing to approve an emergency contraceptive (EC) for over-the-counter access.

The Center for Reproductive Rights filed a lawsuit against the acting commissioner of the Food and Drug Administration in January for failing to approve an emergency contraceptive (EC) for over-the-counter access. The lawsuit was filed hours after the FDA decided it would delay a decision to make the EC product Plan B available to women aged 16 and older without a prescription.

Last year, the FDA rejected a similar request to make Plan B available without a prescription to women of all ages. The FDA cited a lack of information on whether the EC could be taken safely by women under the age of 16 and whether it would promote risky sexual behavior.

In response, Plan B's manufacturer modified its application for over-the-counter status by limiting access to those aged 16 or older. The FDA responded by delaying its decision.