Obama, Sebelius, and Plan B: Politics vs. Science?
by John Corker | Wright State University
Last week, in a highly unusual turn of events, Secretary of Health and Human Services Kathleen Sebelius overturned an FDA ruling that would have allowed “Plan B” emergency birth control pills to be sold over-the-counter (without a prescription) to any female of reproductive age. Currently, the FDA allows these drugs to be sold over-the-counter (OTC) to females seventeen years of age and older, while younger girls must have a prescription from their doctor. The product is stored behind pharmacy counters, and ID is required to verify a customer’s age.
Plan B is a single pill that sells for about $50. It consists of a high dose synthetic female hormone called progesterone and, when taken within 72 hours of intercourse, has been proven to effectively prevent pregnancy. This high dose of progesterone acts in two ways: 1.) By preventing the release of eggs from a woman’s ovaries (all but eliminating the opportunity for fertilization by sperm), and 2.) Impeding the proliferation of a woman’s uterine lining (preventing implantation should a rogue egg be fertilized).
The drug’s manufacturer, Teva Pharmaceutical Industries Ltd., had submitted an application to the FDA months ago to have the age limit on OTC sales lifted. In doing so, they cited study results from the Center for Drug Evaluation Research (CDER) that found the drug to be safe and effective in females twelve years of age and up. In addition, an FDA review board found the study’s results to reliably indicate that a clear majority of this age group understood that the drug was for emergency use only, that it would not protect against sexually transmitted diseases, and that this younger age group could safely and effectively use the product without the intervention of a health care professional. FDA commissioner Margaret Hamburg cited the scientific validity of these study results specifically in a statement regarding her decision to approve Teva’s application.
However, in her surprising move to overrule the FDA’s decision, Secretary Sebelius stated that she did not believe that the study provided adequate data regarding all girls who may seek and procure the drug. She stated that approximately 10% of eleven year-olds are physiologically capable of becoming pregnant, and that there are “significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” which she believes “are relevant to making the determination as to non-prescription availability of this product for all ages.” What’s more, in a statement released a day after this controversial decision, President Obama stated his support of Secretary Sebelius’ decision and the reasoning behind it. While he denied having any influence over the decision, he stated that – as a father of two daughters – he thought it reasonable to apply some “common sense” to decisions such as these.
As would be expected, liberal leaning Women’s and Reproductive Rights organizations were outraged by this decision. In this case, they believe that President Obama – who has always billed himself as a champion for sound science – placed politics above science in anticipation of his 2012 re-election campaign. They feel that President Obama saw this as an opportunity to attract more conservative voters who consider Plan B to be an abortifacent and for whom “Right to Life” issues take precedence in their voting deliberation. Of course, they also feel that this decision comes at the calculated expense of a liberal base that is unlikely to vote for any of the myriad Republican candidates who differ from them on so many other important issues. And while this alleged calculation may just pay off for President Obama in the long run, many predict that he will take a big hit in the support of unmarried females under the age of 35. This demographic contains millions of college students and primarily liberal-leaning women who came out strongly for Obama in 2008 and for whom Women’s Reproductive Health is a key issue.
But left-leaning political groups aren’t the only ones outraged. Both the American College of Obstetrics and Gynecology (ACOG) and the American Academy of Pediatrics (AAP) issued statements in strong opposition to this decision. They cited the “significant implications” that unintended pregnancy can have on adolescent females’ physical and emotional health, especially in cases of rape and incest. In addition, they came out in support of the scientific validity of the CDER study’s findings, stating that “Emergency contraception is a safe, effective back-up birth control method for teens and women of all ages to prevent unintended pregnancy.” Moreover, many physicians are concerned that – due to the inherent limitations of their own time and resources – a prescription requirement may make it impossible for young girls to obtain Plan B emergency contraception within the 72 hour post-intercourse window necessary to prevent unplanned pregnancy.
Clearly this is an issue that will be hotly debated all the way through next year’s Presidential elections. In his 2008 campaign, President Obama vowed never to allow politics to interfere with or supersede sound science. And while its specific political implications are yet to be determined, 0ne thing we know for sure is that his decision to support Sebelius’ ruling will provide plenty of “flip-flopper” fodder for his Republican opponents in 2012.John Corker is the NextGen Journal Health Care Correspondent and a third-year student at the Wright State University Boonshoft School of Medicine. He is a 2007 graduate of the University of Notre Dame and a host of the 'Radio Rounds' medical talk show (www.radiorounds.org).