TOPICS > Health

Morning-After Pill Maker Reapplies for Over-the-Counter Status

BY Admin  July 22, 2004 at 5:34 PM EST

The Food and Drug Administration in May denied Barr’s original request to make its Plan B emergency contraceptive available over the counter to women of all ages.

Despite a 23-4 vote from an FDA advisory panel of outside experts in favor of allowing sales without a prescription, the agency rejected Barr’s application citing insufficient evidence that girls aged 11 to 14 could use the drug safely. The FDA typically follows the recommendations of its advisory panels.

“We are pleased to be responding to the FDA with a submission that we believe will lead to approval of use of Plan B emergency contraceptive as an over-the-counter product for women 16 and older [and] will maintain the availability of Plan B as a prescription-only product for women age 15 years and younger,” Dr. Carole Ben-Maimon, president and COO of Barr Research, said in a statement.

The FDA had no comment on Thursday’s announcement.

The American College of Obstetricians and Gynecologists (ACOG) has called for the drug to be made available without a prescription, arguing it would increase women’s ability to get the pills in time to prevent pregnancy. Although Plan B is highly effective for 72 hours — cutting a woman’s chance of getting pregnant by up to 89 percent — it works best in the first 24 hours.

“ACOG and other organizations have estimated that greater access to emergency contraceptives could significantly reduce the U.S. abortion rate. Everyone should support measures that help decrease the number of abortions in the U.S. The FDA, by failing to take action based on sound scientific evidence, apparently does not,” the group said in a statement released in response to the FDA’s May decision.

Some opponents of easing the availability of Plan B are concerned that it might cause fewer teenagers to use condoms.

“There is a real concern that this is going to be exposing our teenagers to more STDs because they’ll be tempted to use it instead of condoms, which are preventing their STDs. It will be keeping them from getting the medical attention that they would now need to go and get if they had a crisis with a potential pregnancy,” Dr. Susan Crockett, who served on the FDA advisory committee, told the NewsHour in May.

When the FDA first issued its May “not approvable” letter to Barr, Acting Director of FDA’s Center for Drug Evaluation and Research Dr. Steven Galson opened the door for the pharmaceutical company to reapply for over-the-counter status.

“Although we did not have sufficient data to approve this application now, I will be working toward the expeditious evaluation of Barr’s response to the not approvable letter. If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward in contraceptive availability in the United States,” Galson said in a May statement.