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FDA announced today it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option. The Agency and the Sponsor will discuss the Sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older. FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor's amended application and the framework by which this medicine can be made available over-the-counter. The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.
Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills—only in the case of Plan B—each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B is currently available to all women as a prescription drug.
In the letter to Duramed, the Agency communicated its plan to proceed working with the Sponsor in order to move Plan B from prescription only to over-the-counter status for woman ages 18 and older. The steps FDA has taken with respect to this application and the letter it issued to the Sponsor of Plan B today underscores FDA's commitment to public health and safety.
This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor's amended application. Foremost in the Agency's concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use. The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency's broad and critical agenda forward.
Letter issued 7.31.06 to Duramed Research (subsidiary of Barr Pharmaceuticals)
http://www.fda.gov/oc/planb/duramed073106.html
Summary Report of Comments Received in Response to ANPRM
http://www.fda.gov/cder/drug/infopage/planB/default.htm
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