Was HHS Correct To Overrule The FDA On Plan B?

Was HHS Correct To Overrule The FDA On Plan B?

December 9th, 2011 // 2:00 pm @

In an unprecedented move, the US Human & Health Secretary Kathleen Sebelius yesterday overruled the FDA and thwarted a move to ease access to the Plan B pill, which is also known as the morning after pill. The contraceptive is available only to women age 17 and older without a prescription, but behind counters. The FDA was willing to make the pill available in store aisles, which would have made it possible for younger teenage girls to purchase without assistance or a prescription.

As we noted yesterday, the decision is likely to renew debate that yet another White House administration chose politics over science. The controversial pill was the subject of a fracas when George W. Bush was president, because some believe that Plan B prevents a fertilized egg from implanting in the womb, and some equate this with abortion. Many doctors and pharmacists still refuse to provide the pill. As a result, President Barack Obama can be expected to face criticism that his administration made this decision in order to appeal to conservatives (back story).

Nonetheless, Sebelius has the authority to override the FDA. And she explained her decision by arguing that Teva Pharmaceutical, which makes the pill, had failed to study whether girls as young as 11 years old could use the pill safely. And since about 10 percent of girls can bear children as early as 11, they need to be studied as well, according to the letter she sent to FDA commish Margaret Hamburg (here is the letter).

In response, Hamburg released a statement making clear that FDA 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 diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider” (read here).

Nonetheless, the overruling won support from some. For instance, US Senator Chuck Grassley, an Iowa Republican, told The Washington Post that “this is the right decision based on a lack of scientific evidence that it’s safe to allow minors access to this drug, much less over-the-counter.” And Jeanne Monahan of the Family Research Council, a conservative advocacy group, told The New York Times that making Plan B available to young women without a prescription would mean fewer chances that doctors would be able to save them from sexual exploitation, abuse and related diseases.

plan-b1Others were appalled by the overruling. One is Susan Wood, who was the top FDA official in charge of women’s health issues, and resigned in 2005 to protest against an agency decision to delay a final ruling on whether the Plan B pill should be more easily accessible. “I don’t understand why anyone at HHS or elsewhere thinks this was a good move for any reason – political or otherwise,” Wood, who is now an associate health professor at George Washington University, tells us.

“This is an administration that prides itself on scientific integrity. The president issued a memo to make all decisions based on science and take politics out of decision making. This just doesn’t hold water. All it does is tell women that they and their health concerns are not valued. They overruled FDA scientific and medical decisionmaking for reasons that have nothing to do with science.”

The pill has generated controversy from the start. It was approved in 1999 as a prescription-only product. In 2003, advocates filed an application for over-the-counter sales and an FDA advisory panel recommended approval. FDA scientists concurred. But the agency delayed a decision, despite public promises by the Bush White House. In 2006, the Bush administration allowed OTC sales to women 18 and older but required a prescription for those 17 and younger.

Two years ago, US District Court Judge Edward Korman ordered the FDA to reconsider its 2006 decision that would allow only women ages 18 and older to buy the pill without a prescription. The agency lowered the age threshold by a year in response. All along the way, though, the debate was fraught with the same sort of emotion that was on display yesterday after Sebelius took action.

By overruling the FDA, however, Sebelius not only ensured the debate over Plan B will continue, but she also opened the door to ongoing speculation that the FDA is becoming politicized and the possibility that many others will questions the motives and machinations behind agency decisions. In short, Sebelius and the Obama administration may have made it harder for the FDA to do its job.

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