Sebelius Was Wrong to Overrule FDA on Plan BIn overruling decisions by the U.S. Food and Drug Administration's professional staff and its commissioner to allow easier access to the emergency contraception Plan B One-Step, Secretary of Health and Human Services Kathleen Sebelius ignored scientific evidence and a carefully conducted two-year inquiry. Sebelius had the authority to do so, but that doesn't mean it was a good idea. Given the medical risks and financial consequences of unplanned teenage pregnancies, her decision advances neither public health nor the public interest. Sebelius ultimately may have to explain her ill-considered action to a federal judge in Brooklyn, N.Y. The FDA process in which she interfered had been ordered by U.S. District Judge Edward Korman. His scathing March 2009 ruling exposed the abuse of FDA procedures by the Bush administration for political purposes and required the agency to reconsider its 2006 denial of approval of Plan B One-Step for use without prescriptions or age restrictions. The case, Tummino v. Torti, is scheduled for a court hearing on Tuesday. In accordance with the judge's order, FDA staff re-examined earlier scientific evidence and scrutinized new studies submitted by the drug's manufacturer, Teva Pharmaceutical Industries. The FDA's Center for Drug Evaluation and Research concluded that Plan B One-Step — a 1.5 milligram tablet of the hormone levonorgestrel, a common ingredient in birth control pills — met the legal requirements for unrestricted over-the-counter sale. Dr. Margaret Hamburg, the commissioner of the FDA, reviewed the center's report and concurred. Then Sebelius stepped in and ordered Hamburg to deny Teva's application. The legal status of Plan B One-Step has not changed, however.
It remains available without a prescription, as it has been since 2009, for adult women and adolescents who are 17 years old or older. And it still is approved for use — with a prescription — by females younger than 17. Sebelius said the studies submitted to the FDA "do not include data on all ages for which the drug would be approved and available over-the-counter" — specifically, research on whether girls at the younger end of the fertility scale could understand the product's label and would follow its instructions. Actually, earlier and recent scientific evidence submitted with Teva's request does include data that found few problems with label comprehension and proper usage for more than 1,600 girls between the ages of 11 and 16. Some women's rights advocates, health organizations and liberal activists have accused Sebelius and the Obama administration of bowing to conservative political pressure going into a presidential election year. But while it takes the issue off the table, President Barack Obama, who said he supported Sebelius' decision but wasn't involved in the process, is unlikely to get conservatives' votes no matter what his administration does. It's understandable that parents would be distressed if a child were keeping secrets about sexual activity. But the FDA's job is not family counseling. Its job is to examine and assess scientific evidence to determine if drugs are safe, if they work, if there are reasons to restrict their availability and, if so, what those restrictions should be. That's what the FDA finally had done regarding Plan B. It is what Sebelius now has undone. REPRINTED FROM THE ST. LOUIS POST-DISPATCH DISTRIBUTED BY CREATORS.COM
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