FDA delays decision on ‘morning-after’ pill
- Feb 15, 2005
The U.S. Food and Drug Administration failed to meet a Jan. 21 deadline for making a decision about over-the-counter (OTC) sale of a “morning-after” pill that many pro-life advocates oppose as an abortifacient.
Barr Pharmaceuticals Inc. confirmed it had received notice from the FDA it had been unable to complete its review of the New Jersey-based firm’s application for OTC sales of the pill.
If its application is approved, Barr would be able to sell the Plan B “emergency contraceptive” without a prescription to women 16 years of age and older. Plan B is now available by prescription only.
The FDA rejected a request from Barr in May for OTC sales, citing a lack of evidence about the pill’s effect on girls 16 and younger. It gave the company an option of reapplying for OTC sales for females 16 and older and prescription sales for girls 15 and younger. Barr resubmitted its request under those guidelines.
The pill works by restricting ovulation in a woman. Supporters argue it will prevent unplanned pregnancies and abortions. Foes of “emergency contraception” say the method also can work after conception, blocking implantation of a tiny embryo in the uterine wall. In such a case, an abortion occurs, pro-lifers point out.
The “morning-after” pill is basically a heavier regimen of birth control pills begun within 72 hours of sexual intercourse.