News flash: Plan B files for OTC status
Over-the-counter (OTC) status for emergency contraception has moved a step closer with the Washington, DC-based Women’s Capital Corp.’s April 2003 filing with the Food and Drug Administration (FDA) to switch its levonorgestrel drug Plan B from prescription to OTC status.
"We look forward to working with the FDA over the next 10 months as it reviews the safety and efficacy of OTC status for Plan B," says Sharon Camp, PhD, company founder and chief executive officer. "We believe that removing the prescription requirement is critical to giving women timely access to backup birth control."
If the FDA approves the application, U.S. women would be able to buy Plan B without a prescription sometime in 2004. Emergency contraception is available without a prescription in California, Washington, and several other states, but it remains a "behind-the-counter" drug that must be requested from a pharmacist, who provides counseling in its use. Similar "morning-after" contraceptives are available without prescription in Europe.
The 59-volume, 15,000-page application contains clinical study data on nearly 11,000 women who have taken the drug after sex to prevent pregnancy. The research encompasses the results of 39 studies, including the recently published label comprehension study1 and the OTC actual use study, which has been accepted for publication by Obstetrics & Gynecology. The actual use study, which at press time was scheduled to appear as early as this summer, was designed to mimic OTC distribution.
The FDA approved Plan B in July 1999; Health Canada approved it in February 2000. Canada is considering nonprescription status for Plan B under an expedited review process.
1. Raymond EG, Dalebout SM, Camp SI. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstet Gynecol 2002; 100:342-349.