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FDA Delays EC OTC Decision by 90 Days

A week before the deadline for deciding whether Plan B emergency contraception will be made available over the counter, the U.S. Food and Drug Administration (FDA) requested a 90-day extension to continue reviewing the pending application. By law, some type of decision was expected by February 20, but the extension may postpone the decision until May.

In December, two advisory committees to the FDA overwhelmingly recommended by a 23 to 4 vote that Plan B be made available over the counter and without a doctor’s prescription. Given that emergency contraception can reduce the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sexual intercourse, and is most effective within the first 24 hours, timely access to the back-up contraceptive option is imperative. Public health advocates are now concerned that politics may be influencing the FDA’s delay.

"We remain hopeful that the FDA will heed the advice of its experts," said Kirsten Moore, President of Reproductive Health Technologies Project, in a statement. "But this latest announcement raises deep concern that political pressure is being brought to bear on the FDA – and that women’s health and well being will suffer as a result."

Opponents of making emergency contraception available without a prescription have expressed concern that increased availability of Plan B would encourage adolescent sexual promiscuity and sexual risk-taking, despite evidence that this has not been the case when emergency contraception is made easily available to young people. Additionally, the two FDA committees unanimously agreed that no data shows that non-prescription availability of Plan B leads to a substitution of emergency contraception for a regular contraceptive method. Further, the increased access to emergency contraception is not associated with increased risk for STDs or pregnancy in young women.

In a letter to Health and Human Services Secretary Tommy Thompson supporting the application to make Plan B available over the counter and without age restriction, the American Academy of Pediatrics and the Society for Adolescent Medicine (SAM), wrote: "There is no evidence to suggest that refusal to provide contraception to adolescents results in abstinence or postponement of sexual activity. In fact, if adolescents perceive obstacles to obtaining contraception and condoms, they are more likely to have negative outcomes to sexual activity."

In a recent development affecting the FDA’s decision, President Bush has nominated current FDA commissioner Dr. Mark McClellan to run the federal Medicaid and Medicare programs. McClellan’s departure from the FDA would mean an interim replacement would assume responsibility for shepherding the Plan B application and final decision.

Barr Pharmaceuticals, Inc., manufacturer of Plan B, remains committed to gaining FDA approval. "We will continue to work closely with the Agency to assist in the timely completion of the review and we are committed to providing any additional data that they may need to reach their decision," said Bruce L. Downey, Barr’s Chairman and CEO. "We believe that availability of the Plan B emergency contraceptive as an OTC [over the counter] product meets a significant unmet medical need, and that OTC status will remove barriers that currently delay the timely availability of Plan B for women who have had unprotected sexual intercourse or experienced a contraceptive failure."

As co-sponsors of the Back Up Your Birth Control campaign, and supporters of increased access to emergency contraceptive options, including the approval of Plan B emergency contraception as an over the counter option, SIECUS will continue to provide timely updates on the FDA approval process.

More information about emergency contraception.