CWA Agrees: FDA Needs Further Input     8/26/2005

Buying restriction cannot ensure patient protection if drug is available OTC.

The Food and Drug Administration (FDA) announced today it needs public input to decide whether Plan B, the “morning-after pill,” can be sold both without a prescription for those over a certain age, yet require a prescription for those under. Concerned Women for America (CWA) testified against over-the-counter sales of the drug, explaining that easy access puts women’s and young teens’ health at risk.

“Studies show that easy access to the morning-after pill does not decrease abortions or pregnancies, but it does increase sexually transmitted disease rates,” said Wendy Wright, senior policy director for CWA. “What’s more, experts have found that men will frequently buy it, and some slip it to unsuspecting women. An age restriction would not hinder men who would buy the drug and give it to underage girls.”

The FDA denied over-the-counter status in 2004 because the drug manufacturer could not prove that Plan B was safe for adolescents.

Barr Labs had submitted a marketing scheme whereby anyone over 16 years of age could buy it without a prescription.

“It is naive to assume any over-the-counter scheme for the morning-after pill would be effective,” Wright said. “A 17-year-old could buy it for a 13-year-old girl. Or worse yet, a pedophile could purchase this drug for his victims. The proponents’ own study, published in the January 2004 Journal of the American Medical Association, found no decrease in the pregnancy rate – refuting the primary argument for easy access.”

“Making the morning-after pill over-the-counter would only benefit those that profit from its increased sales – but the real price will be paid by women and girls who would suffer the health consequences,” Wright said.

For more information and research, see CWA’s paper, written after the FDA’s 2004 decision: Click here.

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