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Unneeded limits on Plan B Politics trumps science in Sebelius’ decision

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Saturday, Dec. 10, 2011 12:41 AM

Rare is the time when politics and medicine mix well, but that seldom prevents various interests from using the former to influence the latter. Nowhere is that tendency more problematic than in conversations and decisions surrounding access to birth control. Accordingly, it is not altogether surprising that politics played a pivotal role in limiting access to a particular form of contraception: the Plan B One-Step.

Health and Human Services Secretary Kathleen Sebelius on Wednesday overruled the Food and Drug Administration decision to make the “morning-after pill” available without a prescription to all who seek it, regardless of their age. Currently, women ages 17 and older can purchase the pill over the counter, but younger girls must have a prescription. Sebelius justified her decision by saying that the FDA had not adequately considered the potential negative consequences that girls as young as 11 years old - who are physically able to become pregnant - could face if they had unfettered access to the medication. That rationale does not pass the laugh test.

Worse, it reveals Sebelius’ decision for the blatant political statement that it was: an overture to social conservatives who oppose emergency contraception of any kind. The FDA had reviewed the medication for more than a decade to ensure that it met safety muster. Given the inherent politics of the pill’s “emergency” function - that it is used to prevent pregnancy after unprotected sex has occurred - extra care no doubt was taken in ensuring the method warranted approval. It did. FDA Commissioner Margaret Hamburg adamantly defended her agency’s findings, further condemning Sebelius’ overruling as purely political: “I reviewed and thoughtfully considered the data, clinical information and analysis ... and I agree with the Center (for Drug Evaluation and Research) 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,” Hamburg said in a statement responding to Sebelius’ announcement, specifically referencing concerns about young girls’ access to the medication.

President Barack Obama’s response to Sebelius’ announcement confirmed the politics of the matter. “The reason Kathleen made this decision is that she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able - alongside bubble gum or batteries - be able to buy a medication that potentially, if not used properly, could have an adverse effect,” Obama said in The New York Times.

The same question could be raised about 11-year-olds having unfettered access to any medication - from aspirin to antihistamines - and young children purchasing any of these treatments, or the Plan B pill should be doing so with a parent close at hand and heavily involved in the decision.

An absence of that consultation suggests issues in the family that extend beyond the FDA’s reach. With her overruling, Sebelius is carrying water for those who argue that making such methods widely available will encourage girls to engage in sexual behavior. That is a false premise, but one that appeals to the right.

Sebelius’ decision was a disappointing milestone for a Health and Human Services secretary. It marked the first time anyone in the position publicly overruled the FDA on a recommendation. For its implications on reproductive rights and privacy issues, the decision should be recognized for what it is: abjectly wrong.

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