August 25, 2006 -- FDA Approves Plan B for Women Over 18 Years

The following is the text of an announcement by the federal Food and Drug Administration yesterday concerning over-the-counter availability of the “morning after” contraceptive known as Plan B:

"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 an 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 younger. Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, and distribution program."

The FDA noted that the announcement "concludes an extensive process that included obtaining expert advice from a joint meeting of two 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."