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FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older

Prescription Remains Required for Those 17 and Under

BETHESDA, MD -- August 24, 2006 -- The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older.

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 has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.

Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:

· Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;
· Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;
· Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and
· Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan B to OTC use. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package.

The agency remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans.


SOURCE: Food and Drug Administration

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