Health Secretary and FDA Clash over Morning-After Pill for Minors
Friday, December 09, 2011
The Obama administration created an uproar in women’s health circles on Wednesday when Health and Human Services Secretary (HHS) Kathleen Sebelius overruled the Food and Drug Administration’s (FDA) decision to allow the Plan B emergency contraceptive to be sold over the counter to teenagers under 17 years old.
Never before had an HHS secretary publicly squashed a decision by the FDA. But with the 2012 presidential election less than a year away, observers pointed out that the decision removed a potentially divisive issue for President Barack Obama’s reelection campaign.
On Thursday, Obama publically supported Sebelius’ decision. “And as I understand it,” he said, “the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old, going to a drug store, should be able to, alongside bubble gum or batteries, purchase a powerful drug to stop a pregnancy. I think most parents would probably feel the same way.”
Plan B One-Step has been available without a prescription to women 17 and older. Sebelius’ decision means anyone 16 and younger will still need doctor’s approval to purchase the drug.
The former governor of Kansas justified her move by saying that the drug’s manufacturer had failed to study whether girls as young as 11 years old can safely use Plan B.
The FDA’s top official, Margaret Hamburg, objected to Sebelius’ rationale. She said in a statement that her agency’s scientists “determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.”
Women’s health advocates criticized HHS for continuing to restrict the so-called “morning after” pill.
Susan Wood, an associate professor at George Washington University's School of Public Health and former FDA assistant commissioner for women’s health during the George W. Bush administration, said “doctors and researchers have repeatedly stated” that “ample research shows Plan B to be safe for women of all ages and appropriate for over-the-counter access. It is deeply disappointing that this administration would repeat the mistakes of the previous one.”
Wood resigned from her post after President Bush kept delaying approval of Plan B for non-prescription use by adults. The Bush administration eventually allowed over-the-counter sales for women 18 and older. Obama lowered the age to 17 in 2009.
Plan B One-Step tablets (levonorgestrel) are manufactured by Teva Pharmaceuticals.
Obama Defends Administration’s Refusal to Relax Plan B Restrictions (by Rob Stein and Anne E. Kornblut, Washington Post)
Plan to Widen Availability of Morning-After Pill Is Rejected (by Gardiner Harris, New York Times)
Women's Groups Outraged by Ruling on Morning-After Pill (by Julie Rovner, NPR)
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