Plan B Ruling Ignores Solid Science, Says FDA Head

Staff Writer

The Obama Administration took power with the promise that politics wouldn't trump science, but many now argue that it has not always lived up to that pledge.

Fallout continued today from yesterday's announcement on emergency contraception by Kathleen Sebelius, head of the U.S. Department of Health and Human Services (HHS). For the first time anyone could remember, HHS overruled a decision by the Food and Drug Administration (FDA).

Specifically, Sebelius said she would not allow Plan B, the emergency contraceptive, to be sold without a prescription to those under 17, a step that FDA had endorsed. (Currently, it's available over the counter only to those 17 years and older; younger teens and preteens need a prescription to access it.) In a statement, Sebelius said that 10% of the younger cohort who might use Plan B are barely 11 years old and may not use the drug properly. Those girls have "significant cognitive and behavioral differences" as compared with older teenagers, she explained.

The decision was immediately attacked by reproductive health groups, who said Sebelius's argument runs counter to the science. In a carefully worded statement, FDA Commissioner Margaret Hamburg also stood up to Sebelius. Hamburg noted that "I reviewed and thoughtfully considered the data, clinical information, and analysis provided by" FDA's drug experts, "and I agree ... that 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 use for all females of child-bearing potential."

Plan B was the source of much controversy during George W. Bush's presidency. Then, FDA was accused of putting politics before science and resisting a move to provide Plan B over the counter to adults and teens alike. Now critics are seeing something similar in the current Administration. As The New York Times noted in a news story, "the Obama administration is taking a more socially conservative stance on Plan B, one closer to that of the Bush administration than to many of its own liberal supporters."

Numerous professional groups, including the American Academy of Pediatrics (AAP), endorse making Plan B available over the counter to everyone. In part, that's because time is of the essence: For Plan B to prevent pregnancy, it should be taken ideally within 72 hours of unprotected sex, although some studies say it can work up to 120 hours later. In a 2005 paper endorsing nonprescription Plan B for girls, AAP lamented that pharmacies often didn't stock the drug and that only 35% of 320 Pennsylvania pharmacies surveyed said they could fill a prescription the day it was requested.

President Barack Obama, asked at a press conference today whether politics had trumped science in the Plan B decision, walked a delicate line. He defended Sebelius and said he agreed with her decision but noted that he had stayed out of the process. Sebelius, he said, "could not be confident" that preteen girls would know how to use a medication that "could end up having an adverse effect. ... When it comes to 12-year-olds or 13-year-olds, the question is, 'Can we have confidence that they would potentially use Plan B properly?' And her judgment was that there was not enough evidence" for that. (The former head of FDA's Office of Women's Health, Susan Wood, was quoted elsewhere as saying that many other much riskier drugs, such as acetaminophen, are widely available without a prescription.)

This isn't the first time the Obama Administration has overruled scientists, including its own. In September, President Obama rejected new air pollution standards proposed by the Environmental Protection Agency. In late 2009, facing an outcry, Sebelius declined to endorse the recommendations of a task force that questioned the value of mammograms given before age 50.

Posted in Health