Contraception - Chemical Methods / Hormonal Contraception / Emergency / Morning After Pill

Approval for Over-The-Counter EC/Plan B Withheld (1/05)

Keeping women and adolescent girls safe for a little longer, the Food and Drug Administration announced its intention on Friday, January 21, to put off its decision on whether to allow over-the-counter availability for Plan B, an emergency contraceptive.

Barr Laboratories applied for over-the-counter status for Plan B in May of 2004 and were told by the FDA at that time that it was “not approvable.” Barr Laboratories resubmitted its request later this past summer with the new requirement that it be available only for girls 16 and older.

The reluctance to approve the emergency contraceptive for teen use may have something to do with similar cases in Europe, where the drug was made available to adolescents without parental consent or physician referral.

In places where over-the-counter contraceptives have been made available, premarital sex has increased.

A recent JAMA study also gives credence to the FDA’s decision to wait. The report, “Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial” found that women who relied on emergency contraceptives did not lower their rates of premarital pregnancy, compared to similar women who did not take contraception pills. [Jessemyn Pekari, Abstinence Clearinghouse E-Mail Update, 01/26/05]