OTC Morning After Pill mired in ongoing controversy

by pharmacy on January 24, 2012

Amid a storm of controversy swirling around hot button political issues like abortion, personhood, birth control, and sex education in schools, RU486 – a contraceptive sold as Plan B One-Step, Ella, and Next Choice – was an understandable target.

The contraceptive must be taken within 72 hours after sex to prevent conception, but it cannot abort an established pregnancy. More than 40 clinical trials have shown that the pill is safe for young women of childbearing age. The average cost of the pill runs between $25 and $50, and it comes as a single dose.

FDA commissioner Margaret Hamburg made it clear that she agreed with the FDA recommendation that the contraceptive be widely available to all women without a prescription, saying, “There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription used for all females of child-bearing age.” The drug has been on the OTC market for women age 17 and over since 2006.

The resounding endorsement from the FDA made the decision by Democrat Kathleen Sebelius, head of the U.S. Department of Health and Human Services, that much more surprising. On December 7, she announced that she would override the FDA decision and decreed that the contraceptive would remain prescription-only for women under 17.

Sebellius cites her reason for overruling the FDA as lack of studies that included 11-year-old girls. About 10% of girls that age could potentially get pregnant. Sebellius said, “I do not believe enough data were presented to support the application to make Plan B One-Step available over-the-counter for all girls of reproductive age.” Part of her reasoning is that adolescent girls may not be mature enough to use the pill wisely.

Women’s rights groups have been harshly critical, calling it a strictly political machination. Kirsten Moore of the advocacy group Reproductive Health Technologies Project said, “We are outraged that this administration has let politics trump science. There is no rationale for this move.”

Cynthia Pearson, executive director of the National Women’s Health Network, said “What else can this be but politics? It’s not science. It’s not medicine. It’s not women’s health.”

Using Sebellius’ reasoning, shouldn’t Nyquil be available to children under 17 only by prescription? How about Flintstones Chewable Vitamins? Advil? Listerine? Drano? What happens if a child buys Listerine and tries to make her breath EXTRA fresh by swallowing?

What do you think? Is it better to err on the side of caution and restrict all OTC medications (and other common household products that might cause harm) from children who may not have the capacity to understand how to use them? Or is it right to restrict access to this medication from 16-year-olds because someday an 11-year-old might somehow misuse a single pill?

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