Deadline set for ruling on ‘morning-after’ pill
- Jul 29, 2005 -
The Food and Drug Administration has set September 1 as the deadline for deciding on over-the-counter (OTC) sale of a “morning-after” pill that can act as an abortifacient.
If the FDA approves the application of Barr Pharmaceuticals Inc., the New Jersey-based firm 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 2004 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. 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 dose of birth control pills. Under the regimen, a woman takes two pills within 72 hours of sexual intercourse and another dose 12 hours later. In addition to Plan B, the FDA has approved prescription use of another “morning-after” pill, Preven.