After the Obama Administration's Morning-After Pill Decision

National Journal

President Obama has made a series of speeches in recent weeks, delighting scientists who work on controversial areas of research and advocates for reproductive and abortion rights.

Then his administration disappointed them this week with a pair of decisions that would help keep over-the-counter access to emergency contraception restricted by age, despite Food and Drug Administration scientific findings that the medication was safe to offer without such limitations.

The administration’s decisions—to fight a judge’s ruling that would make the drug called Plan B freely available, while approving a new application that would allow girls as young as 15 to buy it over the counter—may appear to be a good political compromise. But it has infuriated reproductive rights activists, and groups of doctors and scientists, who feel that drug policy should not be influenced by political considerations.

 “It’s something beyond the science, beyond medicine and beyond the FDA’s normal process,” said Susan Wood, an associate professor of public health at George Washington University in a conference call with reporters. Wood, a former assistant FDA commissioner, resigned from the agency in 2005 in protest against the Bush administration’s management of the emergency contraceptive application.

In addition to many women’s and reproductive rights groups, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Union of Concerned Scientists oppose the administration’s recent Plan B decisions.

Earlier this week, Obama told the National Academy of Sciences that it was important to protect the “integrity of our scientific process.” “We’ve got to make sure that we are supporting the idea that they’re not subject to politics, that they’re not skewed by an agenda, that, as I said before, we make sure that we go where the evidence leads us.”

Last week, he spoke at the annual conference of Planned Parenthood, making him the first sitting president to do so. “We shouldn’t have to remind people that when it comes to a woman’s health, no politician should get to decide what’s best for you,” he said. 

Advocates are more upset about what the Obama administration did in 2011 than its actions this week. In reality, this week’s actions actually expand access to Plan B significantly. But the new events have stirred up old anger by reminding advocates that the administration did not follow the advice of its own scientists.

“I would love to believe that President Obama would live up to his soaring and very inspiring rhetoric at the Planned Parenthood dinner last week,” said Terry O’Neill, the president of the National Organization for Women, who said she was disappointed by the administration’s record on Plan B.

In 2011, Health and Human Services Secretary Kathleen Sebelius stepped in to overrule an FDA determination and to prevent approval of the drug for unrestricted over-the-counter sales. The FDA found that the drug was effective in preventing many pregnancies when taken shortly after unprotected sex, and that it was safe enough that it could be taken by women and girls at all ages without a doctor’s supervision. At the time, Sebelius said that the company had not prevented ample evidence that young girls would be able to use the drug appropriately.

In an interview with National Journal Thursday, Sebelius defended that decision. “I felt there was a lack of data around the youngest girls, because they had no clinical data,” she said.

The administration’s actions this week are more technical in nature than its election-year decision to overrule the agency. First, FDA approved an updated application by the drug’s manufacturer, which had asked to offer the drug over-the-counter to women 15 and older. The FDA’s approval means that older teenagers wont need a prescription to buy the drug, which prevents pregnancy by delaying ovulation. But they will need to prove their age with a government-issued form of identification, a requirement that advocates worry could be a barrier to poor women who don’t have identification, or younger teens who are not eligible for drivers’ licenses. (FDA says they can use a passport or a birth certificate instead.)

Then, the Justice Department appealed a recent federal court decision, in which the judge had ordered the FDA to make the drug available over-the-counter without age restrictions. The challenge is focused on procedural concerns, but it still asks an appeals court to overturn the order.

In 2011, Obama defended Sebelius saying that he didn’t think it would be appropriate to allow girls as young as 10 or 11 to buy contraception “alongside bubblegum or batteries.” “I think most parents would probably feel the same way,” he said.

The administration’s newest moves echo this commonsense, intuitive approach. But it does not reflect a change in scientific judgment. And that means that supporters of expanded access aren’t cheering for this partial victory.

 

 

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