 |
|
The New York Sun, January 26, 2005 Women Sue FDA
For Right To Buy Emergency Pill In what is described as the first lawsuit of its kind, women are suing the Food and Drug Administration, demanding to be able to buy a type of emergency birth control without a prescription. Plaintiffs in the suit, which was filed in federal District Court in Brooklyn late last week, include nine individuals and two advocacy organizations. They argue that FDA foot-dragging on making the emergency contraceptive, Plan B, available on an over-the-counter basis is restricting women's access to a safe form of emergency birth control, which they say amounts to a kind of sex discrimination. They want to force the federal agency to make a decision on the matter, which it has now been deliberating 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," the lead plaintiff in the case and vice chairwoman of the New York Reproductive Rights Task Force, Annie Tummino, said. "We have been pressuring the FDA in public campaigns over the past year, and at this point, legal challenges are our next best recourse." 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%, 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, Ms. Tummino said. Advocates of the drug believe that making emergency contraceptives available on drugstore shelves would be preferable to having women face a choice later between motherhood and abortion. 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. "They are demanding what they want with no concern with how this drug will impact innocent women and girls," the senior policy director of Concerned Women for America, Wendy Wright, said. A study published in the January 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. In 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. Last week, the FDA was expected to issue a decision on Barr Laboratories' amended application, 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 of the matter. The application is still pending, an FDA spokeswoman said, and no target date for a decision has been established. "Emergency contraceptives are really the best thing since sliced bread for women," the director of the domestic legal program for the Center for Reproductive Rights, Priscilla Smith, said. "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." Ms. Smith said the FDA's foot-dragging on its decision is effectively restricting access to the contraceptive for all women, infringing a right outlined 40 years ago by the Supreme Court in the case of Griswold v. Connecticut. Ms. Smith accused the FDA of ignoring accepted medical data that the drug can prevent unwanted pregnancies. More than 70 medical and advocacy organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, endorsed Barr Laboratories' application in a December 2003 letter to the FDA. If emergency contraceptives are widely available, the rates of unintended pregnancy and abortion in America could be reduced by up to one-half, according to the letter. Though a spokeswoman for Barr Laboratories, Carol Cox, declined to comment on the newly filed suit, she expressed hope that the FDA would allow over-the-counter sales of Plan B soon. Groups fighting against expanded access to the drug issued a caution against court intervention in the drug approval process. Ms. Wright said that if the plaintiffs in the
Brooklyn case prevail, "then the FDA would
be peppered with lawsuits from advocacy groups
looking for their drug to be approved."
Home About Us Newsletters News Archives Donate
|