Generic Plan B Pregnancy Prevention Approved for Teens

A generic version of the morning-after-pill known as Plan B has received Food and Drug Administration (FDA) approval for prescription use by women aged 17 and under. For the present the pill is available only to those under 17, but it will be available for other ages after August 24 when the exclusive market rights of Duramed Pharmaceuticals, Inc. manufacturers of the original Plan B expires. The new generic version is manufactured by Watson Pharmaceuticals of Corona, California. They call their version “Next Choice.”

The original pill was approved in 1999 for women of all ages and was dispensed by prescription only. In 2006 non-prescription use was approved for women ages 18 and older, but younger women could obtain the pill only by prescription. The 18-year-old age limit had been imposed by the Bush Administration. In April 2009 a federal court decided that this age limit was politics and not science and the FDA was directed to make Plan B available to those 17 years and younger without a prescription.

This did not mean that 17 year olds had immediate access to the drug, only that the manufacturer could make an application for over-the-counter sales to those 17 and younger. To date there is no information that such an application has been filed. If the drug was approved for OTC sales it would not be on open shelves, but would be available through the pharmacy.

If taken within 72 hours of intercourse the generic version (levonorgestrel 0.75 mg) reduces the risk of pregnancy. According to scientists it does not terminate a pregnancy. The drug is a contraceptive only, and it will not protect against sexually transmitted diseases, including HIV.

The morning-after-pill has generated controversy since it was first available, and the current decision to make it available to teenagers without prescription has disturbed conservatives.  They believe that it will degrade the family by allowing teenagers access to contraceptives without their parents approval. Some pro-life advocates consider the concept of the pill not as “emergency contraception” but a form of abortion.

In MedPage Today, Cecile Richards, president of Planned Parenthood Federation of America, called the announcement “a strong statement to American women that their health comes before politics. This decision is commonsense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women.”