BREAKING: Sebelius Overrules FDA Approval

For the first time in history the Secretary of Health and Human Services has overruled an agency decision, specifically the FDA’s decision to approve the morning-after-pill for over the counter use by all women regardless of age. According to Secretary Sebelius:

“In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.”

FDA Commissioner Margaret Hamburg disagreed with Secretary Sebelius, and in a press release stated:

“The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER 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….I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center 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.”

Commissioner Hamburg went on state that Secretary Sebelius issued a memorandum stating she did not agree with the agency’s determination. As a result Plan B One-Step remains available over the counter to women over the age of 17 and by prescription for women younger than 17.

 

 

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  1. […] you probably heard, on December 7, 2011, in a precedent setting action, the Secretary HHS, Kathleen Sebelius, over-ruled an approval decision of the federal Food and Drug […]