Allowing Plan B drug maker

The FDA has complied with a federal court order issued on March 23, 2009, by allowing Plan B drug maker, Barr Pharmaceuticals Inc, now part of Teva Pharmaceutical Industries Limited, to submit an application for approval for the pill to be made available to women 17 and older without a prescription. The court order directed the FDA to comply with within 30 days of the decision. Based on scientific findings made in 2005 by the Center for Drug Evaluation and Research, the agency has decided not to file an appeal. In as little as ten months, seventeen-year-old girls will have access to the emergency contraception, commonly called the "morning after" pill, without a prescription. Prior to the March court order, the nonprescription use of Plan B had been restricted to those eighteen and older, although Barr Pharmaceuticals had previously sought access for girls sixteen years of age and older.Many conservative groups oppose nonprescription access to Plan B, arguing that it's easy access could lead to promiscuity and could possibly become a tool for sexual predators and criminals running prostitution rings. However, women's health advocates are exuberant over decision with their belief that because Plan B is safe and effective in preventing unwanted pregnancy, it could help reduce the number of abortions. In addition, many believe that Plan B should be made available with no age restrictions arguing that it is crucial for women to have fast access to the drug, as it is highly successful in preventing pregnancy when used within twenty-four hours of having sexual intercourse. In a statement, Wendy Wright, president of the conservative group Concerned Women for America said, "The FDA violated its standards when it made the high dose Plan B available nonprescription to adults. But now the FDA is making the drug available to minors without parental consent." She then added, "The FDA should have challenged the decision." Others who oppose the relaxed access to the contraceptive say that Plan B is the equivalent of an abortion pill as it can prevent a fertilized egg from attaching to the uterus. Recent research suggests that this is a possibility, although an unlikely one. According to Nancy Northup, president of the Center for Reproductive Rights, which initiated the lawsuit in 2005, "It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science." Amy Allina, policy director of the National Women's Health Network, stated that the FDA's decision "gets us part way to where we believe the FDA should be." However, she also noted, "Putting it behind the counter does not make it safer or more effective. In fact, because it creates another barrier it's likely to make it less effective." The Plan B dosage consist of two pills that contain higher amounts of progestin than are used in prescription birth control pills. It works by preventing ovulation or fertilization and when taken within 72 hours of having unprotected sex, it can reduce the chances of pregnancy by as much as 89 percent. The treatment sells for $35 to $60 and women must ask for Plan B at the pharmacy counter and provide identification having proof of age. According to Teva, even with restrictions, sales of Plan B "have more than doubled" since becoming available to adults from pharmacists in 2006.