Morning-After Pill Is Over the Counter
FDA OKs 'Plan B' to Be Sold Without Prescription to Women 18 and Older
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What Plan B Is and Isn't continued...
Plan B is one of two approved emergency contraceptives. The other is Preven from Gynetics Inc. Gynetics has not asked for over-the-counter status, so today's FDA action applies only to Plan B.
Plan B works like other birth control pills to prevent pregnancy. Plan B acts primary by stopping the release of an egg from the ovary. It may prevent a sperm from fertilizing the egg.
If fertilization does occur, Plan B may prevent a fertilized egg from attaching the womb. If a fertilized egg is implanted prior totaking Plan B, it will not work and pregnancy proceeds normally.
Plan B is not the same as RU-486, the so-called "abortion pill," which causes a chemical abortion after pregnancy occurs.
Path to Over-the-Counter Approval
Plan B has been available by prescription to women of any age since 1999. Its maker, Barr Pharmaceuticals, has long sought FDA approval to market Plan B available over the counter.
In April 2003, Barr applied to market Plan B an over-the-counter drug. In December 2003, an FDA advisory committee met to discuss Barr's application.
The committee backed Barr's application. But the FDA decided it needed more information about how Plan B could be safely used by adolescents without supervision by a licensed practitioner.
In March 2004, Barr submitted another application, this time limiting Plan B's over-the-counter sales to women at least 16 years old.
In May 2004, the FDA declined to complete its review of that application, calling Barr's proposal "preliminary and incomplete."
Barr subsequently submitted more information in support of its application. In August 2005, the FDA again delayed a decision.
Lester M. Crawford, DVM, was FDA commissioner at the time. He issued a statement on Aug. 26, 2005 citing "unresolved regulatory and policy issues" as the reason for the delay.
In his statement, Crawford noted that the FDA had concluded "the available scientific data are sufficient to support the safe use of Plan B as an over-the-counter product, but only for women who are 17 years of age or older."
Susan Wood, assistant FDA commissioner for women's health and director of the Office of Women's Health, resigned in August 2005 in protest over the FDA's delays on Plan B.