FDA approval of new contraceptive stirs reaction

Posted: 9/06/06

FDA approval of new contraceptive stirs reaction

By Robert Marus

ABP Washington Bureau

WASHINGTON (ABP)—After a three-year-long debate, the federal Food and Drug Administration has approved wider distribution of a “morning-after” contraceptive, angering some religious conservatives and anti-abortion groups.

FDA officials recently announced they had approved non-prescription sales of “Plan B,” a drug designed to prevent ovulation and fertilization of a woman’s egg. The decision, however, only allows women 18 years of age or older to have over-the-counter access to the drug.

The decision came just days after the agency’s acting director said he was prepared to expand the drug’s availability and President Bush expressed solidarity with that decision. Both actions angered some groups opposed to abortion rights.

“Unfortunately, the responsibility for the deaths of an untold number of preborn children rests on the shoulders of our federal government,” read a statement issued immediately after the decision by the American Life League.

Plan B is different from RU-486 (also known as Mifeprex or mifepristone), which the FDA has already approved amid similar controversy. It is intended to end pregnancies after an egg has been fertilized.

Plan B has been available for several years on a prescription basis to women of all ages. It contains higher doses of chemicals used in common birth-control pills. The two-pill regimen is supposed to be taken as soon as possible after sexual intercourse, in order to prevent an unintended pregnancy.

Some research has shown that the drug can, in rare circumstances, also prevent the implantation of a fertilized egg in a woman’s womb. Pro-life groups consider that tantamount to abortion, and have opposed widening availability of Plan B for that reason. They also have opposed the drug on the basis that it may lead to more promiscuity.

Some contend the drug may be dangerous for adolescent girls to use without a doctor’s supervision.

Due to the opposition, making Plan B available on a non-prescription basis has been tied up in FDA approval channels since 2003. That year, an advisory panel of outside scientists voted overwhelmingly to approve the manufacturer’s request to allow over-the-counter availability.

But a Bush appointee at the agency decided not to accept the recommendation—spurring charges that the agency was reacting to President Bush’s conservative religious backers rather than experts on the drug.

The agency continued to delay a final decision on the issue, and controversy over it continued to mount, until mid-August of this year. That’s when President Bush’s current appointee to head the FDA, Andrew von Eschenbach, said he would support allowing over-the-counter Plan B sales to adult women. President Bush said he backed von Eschenbach’s position.

FDA officials reached an agreement with the pill’s manufacturer to limit non-prescription sales of the drug to pharmacies and health clinics, and they will still require women to show identification when requesting the drug.

In a memorandum the FDA released along with the announcement, von Eschenbach said that using “well-established state and private-sector infrastructures will allow for comprehensive and effective enforcement of the age-based restrictions.”