President Obama said las week that he would support the Department of Health and Human Services overruling an FDA decision to allow an emergency morning-after contraceptive pill to be sold to girls younger than 17 without a prescription.
Obama spoke at a White House news conference, “I did not get involved in the process…[but] as the father of two daughters,” he supported HHS Secretary Kathleen Sebelius' decision, which activists, doctors and scientists have criticized as political.
On Wednesday, the FDA approved the sale of Plan B One-Step emergency contraception as an over-the-counter medication to girls younger than 17. It was already and will continue to be available to women 17 and older without a prescription. FDA Commissioner Margaret Hamburg said in a statement, “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 non-prescription use for all females of childbearing potential.”
Sebelius and now Obama decided 10- and 11-year-olds should not be able to buy the drug “alongside bubble gum or batteries” because it could have an adverse effect if not used properly. He said "most parents" probably feel the same way. White House press secretary Jay Carney emphasized Thursday that Obama had no influence on Sebelius' decision.
Sebelius said she made the decision because she was not sure young girls would understand how to use the medication, and that there had been no studies to show that young girls — potentially as young as 11—could understand the label. It was the first time an HHS secretary overruled an FDA decision. “It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius said in a press statement. “If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
Sebelius has the right to make policy about Plan B, but she undermined the FDA's ability to decide based on the best scientific research, said Francesca Grifo, director of the Union of Concerned Scientists' scientific integrity program. “FDA reviewed all of the research that was in hand and found that it was safe,” Grifo said. “Secretary Sebelius used that cloak of science for not approving Plan B. Who is she to be reviewing the work of scientists at the FDA?”
If the decision is political, it needs to be debated that way, said Cora Breuner, a University of Washington medical school professor who wrote an American Academy of Pediatrics paper on the issue. Breuner said she didn't think 11-year-olds would be asking for Plan B, in part because it costs $40 to $50. Very few 11-year-old girls would need the pill, Breuner said, and if they did, it would probably be the result of sexual abuse. If so, a family member or doctor should be involved.
Among older teens, Breuner said, 10% to 15% of girls 15 to 17 who have unprotected sex didn't give consent. They should be able to get Plan B quickly, she said. And, even older teens or young women shouldn't have to go through the barriers of asking a pharmacist behind a counter for the medication, she said. “Safety really isn't the issue,” she said. “The FDA went through this with a fine-toothed comb and found it was safe.”
“When President Obama took office, he pledged the administration's commitment to scientific integrity,” said Cynthia Pearson of the National Women's Health Network. “This decision is a betrayal of that promise.”
“When it comes to FDA drug approvals, contraceptives are being held to a different and non-scientific standard — in a word, politics,” said Nancy Northup, president of the Center for Reproductive Rights. She said the comments by Obama and Sebelius would suggest no FDA-approved drug — not a Tylenol or a Sudafed — should be on drugstore shelves.
Susan Wood, who resigned from the FDA in 2005 because she Plan B approval was delayed for political reasons, called Sebelius' decision “stunning.” Wood is now executive director of the Jacobs Institute of Women's Health at George Washington University. “Sadly, once again, FDA has been over-ruled and not allowed to do its job,” she said in a press statement. “I cannot understand why Secretary Sebelius would reach in and overturn the FDA's decision to allow timely access for all those who need safe and effective emergency contraception.”
According to the Guttmacher Institute, fewer than 1 percent of 11-year-old girls are sexually active, but almost half of girls have had sex by their 17th birthdays, most of those beginning at age 15 or 16. Teva, the manufacturer of the Plan B pills, said a study showed the contraceptive safe for 12-year-old girls to use. To use the contraceptive, women must take one pill within 72 hours of having unprotected sex, according to the medication's label.
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