FDA may be ready to OK over-the-counter sale of 'morning-after' pill


WASHINGTON — The Food and Drug Administration has signaled it may be prepared to permit an emergency contraceptive with abortion-causing qualities to be sold over the counter.

The federal regulatory agency announced July 31 it is working with Duramed, a subsidiary of Barr Pharmaceuticals, toward possible approval of Plan B on a non-prescription basis for women 18 years of age and older. Barr previously had asked the FDA to approve over-the-counter sale of Plan B, which also is known as a "morning-after" pill, to females 16 and older.

Plan B, as well as another "morning-after" pill known as Preven, 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. The "morning-after" pill can act after conception, thereby causing an abortion, pro-lifers point out. The method can block implantation of a tiny embryo in the uterine wall.

Plan B and Preven are now available only with a prescription.

"If the conversations go smoothly and everyone works expeditiously through this, we think this is something that could be wrapped up in a matter of weeks, not months," a FDA official told Reuters News Service.

Judie Brown, president of the American Life League, said her organization was "aghast that the [FDA] has caved to mounting political pressures."

"The FDA, as an arm of the federal government, is supposed to protect its citizens — not put them at risk for death," Brown said in a written statement. "The FDA should not have authorized any use of this risky drug regimen in the first place and it certainly should not make it readily available over the counter."

The FDA postponed last August a decision on Barr's request to sell Plan B over the counter. In May 2004, the agency rejected Barr's appeal for over-the-counter 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 over-the-counter sales for females 16 and older and prescription sales for girls 15 and younger. Barr resubmitted its request under those guidelines.