National NOW Times >> Fall 2004 >> Article
Emergency Contraception Remains Inaccessible to Many
by Michele Keller, Internet Communications Manager
Ignoring a 23 to 4 vote from its own expert panel and disregarding staff recommendations, the Food and Drug Administration rejected Barr Pharmaceuticals' application in May for over-the-counter (OTC) sale of Plan B emergency contraception (EC), also called the "morning-after pill."
The FDA barred the OTC-release of the medication, which prevents pregnancy if used within 72 hours, saying insufficient evidence existed to prove its safety for teenage girls who might use the drug.
"This is an outrageous politicization of an important public health issue," said NOW President Kim Gandy, who testified at the FDA advisory committee hearing about over-the-counter EC sales in December 2003.
"The medical experts are clear that EC is safe to sell over-the-counter, and we know it enhances women's ability to prevent unwanted pregnancies. Our rights and health are being traded away for political gain. We will fight back."
Currently, only six statesAlaska, California, New Mexico, Maine, Hawaii and Washingtonallow pharmacists to provide EC without a prescription.
In some statesMississippi, Arkansas, Illinois and South Dakotapharmacists and medical providers may refuse even to fill EC prescriptions if doing so conflicts with their religious beliefs. South Dakota's law specifically states that pharmacists may refuse to fill a prescription if "there is reason to believe it will destroy an unborn child"despite the fact that EC prevents embryo implantation, but does not affect an existing pregnancy.
Often no official policy exists, so women seeking EC do not know which doctors, pharmacists or hospitals will dispense it and which will not.
EC must be taken within 72 hours after sexual intercourse to be most effective in preventing pregnancy. Any delay in a woman taking EC could add one more to the 3 million unplanned pregnancies in the United States each year. More than half of these pregnancies end in abortion. Barr Pharmaceuticals Inc. submitted a revised proposal to United States regulators July 23 to allow OTC sales of Plan B for women 16 and older. A decision by the FDA is pending.
Reproductive-rights advocates say the lack of consistent policy on OTC sales of EC keeps medication from women who most need it, including those needing EC over a weekend when doctors are inaccessible.
"This drug is about responding to emergencies, a result of unwanted sex or contraceptive failure," Gandy said.
"Making Plan B available for over-the-counter sale to all women would reduce the stress and trauma experienced by women in these emergency situations, while preventing thousands of unwanted pregnancies."
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