FDA Stymies Choice

Catriona Stuart Feb 10, 2005

By Catriona Stuart

In a lawsuit filed against the Food & Drug Administration (FDA), women are demanding that they be able to buy an emergency birth control pill without a prescription. Nine individuals and two advocacy organizations are the plaintiffs in the suit, which was filed in federal District Court in Brooklyn. They argue that the FDA is stalling on making the emergency contraceptive, Plan B, available over the counter is restricting women’s access to a safe form of emergency birth control. The agency has been deliberating on the matter for nearly two years.

“It is clear that the FDA has been dragging its feet for a very long time on an issue that is really very simple,” said the lead plaintiff in the case, Annie Tummino, vice chairwoman of the New York Reproductive Rights Task Force.

FDA officials declined to comment on the suit.

Taken within 72 hours of unprotected sexual intercourse, Plan B can reduce the risk of unwanted pregnancy by up to 89 percent, though the drug is most effective when taken within 24 hours after intercourse, according to the drug’s manufacturer, Barr Laboratories.

Getting a doctor’s appointment and finding the medication within the 24-hour window can be difficult and expensive, Tummino explained. Advocates of the drug contend that making emergency contraceptives available on drugstore shelves would be preferable. Anti-abortion groups opposed to the drug have said, however, that making Plan B available without a prescription could pose a threat to women’s health and increase rates of unprotected sex and sexually transmitted diseases among teenagers.

A study published in the Jan. 5 issue of the Journal of the American Medical Association reported that women who have ready access to emergency contraception are no more likely to engage in unprotected sexual activity than women who do not have access to the pills. The study also found similar pregnancy rates among women whether or not they had nonprescription access to an emergency contraceptive.

Last May, the FDA rejected Barr Laboratories’ petition to make Plan B available without a prescription – against the recommendations of two of the agency’s advisory committees. The FDA’s “non-approvable letter” to the manufacturer cited inadequate data regarding the impact of the drug on adolescents.

The FDA was expected to issue a decision on Barr Laboratories’ amended application last month, which would have made the drug available without a prescription only to women 16 and older. Instead, the agency said it had not yet completed its review. The application is still pending, an FDA spokeswoman said, and no target date for a decision has been set.

“The FDA’s mandate is to approve drugs when it is in the public interest to do so, and by delaying that, they are violating federal law,”said Priscilla Smith, director of the domestic legal program for the Center for Reproductive Rights.

Smith said the FDA’s foot-dragging on its decision is effectively infringing on a right outlined 40 years ago by the Supreme Court in the case of Griswold v. Connecticut.

More than 70 medical and advocacy organizations sent the FDA a letter in 2003 that stated the rates of unintended pregnancy and abortion in America could be reduced by up to one-half should emergency contraceptives be widely available.

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