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Women's health advocates decry Plan B decision

Pharmacist holds package of "Plan B" emergency contraceptive tablets
Pharmacist holds package of "Plan B" emergency contraceptive tablets, on texture with FDA logo, 2006/8/24 AP

Abortion rights groups and women's health advocates are expressing disappointment and anger today after the Health and Human Services Department decided to keep the Plan B morning-after pill from being sold over the counter.

Some are suggesting the move -- which overrules a decision from the Food and Drug Administration and the agency's scientists -- was made for political reasons. At least one former FDA official is calling on President Obama to reverse the decision.

"This is really unprecedented in terms of overturning a decision about a drug approval," Dr. Susan Wood, former FDA Assistant Commissioner for Women's Health and a professor of at the GW School of Public Health and Health Services, told Hotsheet. "This is taking decision making out of the hands of the FDA, and that is a terrible precedent not just for contraceptive products, but for all things the FDA does."

Wood resigned from the FDA on principle in 2005 over the continued delay in approving emergency over-the-counter contraception. She said she's surprised by today's development because it "seems counter" to the memo Mr. Obama issued in 2009 promising to restore "scientific integrity to government decision-making."

"I call on President Obama to enforce that directive that he gave and to not tell FDA what decision to make, but to tell the [HHS] secretary to let the FDA to do its job," Wood said. "He's the only one he can do it at this point."

Currently, Plan B is sold behind pharmacy counters and is available without a prescription only for those 17 or older. The Food and Drug Administration was prepared to lift the controversial age limit and make Plan B One-Step available over the counter, when HHS Secretary Kathleen Sebelius overruled the decision at the last minute.

Nancy Keenan, president of NARAL Pro-Choice America, expressed "profound disappointment" in the decision in a statement today, pointing out that experts like American Academy of Pediatrics endorsed moving emergency contraception to drug store shelves years ago.

"We had every confidence that this Bush-era policy would come to an end," Keenan said. "The Obama administration has broken a key promise to the American people that it would base its decisions on sound science and what's in the best interest of women's health. In short, this is a failure to deliver change."

The age limit has already been contested in court -- in 2009, a federal judge said the FDA had set the restrictions initially based on politics, not science, and ordered the agency to rethink its decision.

Jodi Jacobson, editor in chief of the reproductive rights site RH Reality Check, wrote that the move once again came down to politics. "If we have been reminded of one thing in the past several months, it is that politicians and religious leaders alike will, when it suits them, marginalize the rights and needs of women to advance their own interests and need for power," she wrote.

In a statement, Sebelius said she made the call because the maker of Plan B didn't prove that all girls of a reproductive age -- as young as 11 -- would be able to understand how to use it without help from an adult. However, FDA Commissioner Dr. Margaret Hamburg said in her own statement that there was "well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential."

Wood says she respectfully disagrees with Sebelius' assessment. Sebelius may have some other source of medical expertise on the issue, "but that's what the FDA is there for," Wood said.

The decision to overrule the FDA was applauded by some, including the conservative Family Research Council.

Jeanne Monahan, director of Family Research Council's Center for Human Dignity, said in a statement that allowing over-the-counter sales of Plan B "would not have been in the interest of young women's health."

Monahan pointed to correlations between Plan B use and high rates of sexually transmitted diseases among adolescent girls. She also argued that making the drug readily available could make adolescent girls more susceptible to sexual abuse and exploitation, since they could be given the drug under coercion.

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