Charlie Riedel/AP
Pharmacist Matt Hartwig holds up a dose of Plan B, which is commonly referred to as the
morning-after pill.

FDA Won’t Challenge “Plan B” Ruling

April 23, 2009 04:30 PM
by findingDulcinea Staff
The FDA will make a controversial pill available to 17-year-old women without a prescription.

Court Battle Ends

The Food and Drug Administration is going to allow 17-year-old women to obtain a pregnancy prevention pill called Plan B without a prescription, the Los Angeles Times reports.

Last month, a federal court in New York ruled that the FDA had to make the drug, known as Plan B, available without a prescription to 17-year-olds. The agency decided not to appeal the ruling, the Los Angeles Times reported.
It’s not clear when Plan B might actually be available to 17-year-olds. According to an FDA news release, the agency “notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription” to people who are above the age of 17.

Currently the contraceptive, also known as “the morning after pill,” is only available without a prescription for women 18 and over. The controversial pill prevents pregnancy and works best when used within 24 hours of sexual intercourse.

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Background: Controversial ruling on plan B

Reproductive rights advocates applauded the judge’s decision.

“Emergency contraception is proven safe and effective, and today we have succeeded in expanding access to 17-year-olds and are one step closer to making it fully available to all women,” said Nancy Northrup, president of the Center for Reproductive Rights.

Many advocates had hoped that such changes would be made to rules governing the pill under the Obama administration.

Emergency contraception opponents, such as the New York State Catholic Conference, which opposes over-the-counter sales of the drug, said less strict rules could cause young women to overuse it as a primary source of birth control.

“It’s a scary situation when a judge who is not a doctor can overrule the FDA on the proper age when someone can take a medication,” conference spokesman Dennis Poust said after the ruling was issued.

The FDA was criticized during the Bush administration for repeatedly bowing to conservative views in its treatment of emergency contraception. Judge Korman wrote that the “the FDA acted in bad faith” and in response “to political pressure” and “repeatedly and unreasonably delayed issuing a decision on Plan B.”

Background: The politics and science of Plan B

Plan B is made up of a hormone called levonorgestrel, which works by preventing the fertilization of an egg or the implantation of a fertilized egg in a woman’s uterus.

Emergency contraception is recommended for women whose primary source of contraception has failed, and is to be used up to 72 hours after intercourse. The sooner the drug is taken, the more successful it is, which is why many advocates have pushed for over-the-counter sales and no prescription.

Some opponents claim that the drug ends a human life; many abortion opponents oppose emergency contraception as well.

It's been a controversial subject for years. Plan B’s manufacturer, Barr Pharmaceuticals, first asked the FDA for permission to sell over-the-counter in 2003, the L.A. Times said, though it took three years for the agency to agree. The L.A. Times said “two independent scientific advisory committees that reviewed the issue for the FDA concluded that the pill was safe,” but the approval occurred “amid stiff opposition from socially conservative interest groups and members of Congress.”

Last month, U.S. District Judge Edward Korman of the U.S. District Court for the Eastern District of New York issued a 52-page ruling that said Plan B must be made available to 17-year-olds without a prescription.

Judge Korman wrote that the “the FDA acted in bad faith” and in response “to political pressure” and “repeatedly and unreasonably delayed issuing a decision on Plan B.”

Reuters reported that the ruling also included that the Food and Drug Administration review its decisions on rules for the drug’s over-the-counter sales; currently Plan B is only available behind the pharmacy counter. The FDA’s initial response after the ruling was that the agency was reviewing the decision. There was no mention of over-the-counter sales in this week's FDA announcement.

Korman’s decision, predictably, was lauded by reproductive rights groups and panned by right-to-life organizations.

Emergency contraception does not cause an abortion, according to a site run by Princeton University’s Office of Population Research and the Association of Reproductive Health Professionals. 

“No, using emergency contraceptive pills … prevents pregnancy after sex. It does not cause an abortion (In fact, because emergency contraception helps women avoid getting pregnant when they are not ready or able to have children, it can reduce the need for abortion.)”

Related Topic: Refusing to sell contraceptives

Much of the controversy around contraceptives, emergency and otherwise, has played out in actual pharmacies: Some pharmacists have refused to sell the drug, and have refused to sell birth control pills.

State regulations regarding the rights of pharmacists to refuse to dispense certain prescriptions vary widely in scope and language. Many follow the American Pharmacist Association’s policy, which states that a pharmacist may refuse to fill a prescription, provided that he or she then refers the customer to a fellow pharmacist or a different pharmacy. Some states mandate that pharmacists fill all lawful prescriptions.

Reference: The decision; women’s health


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