On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius overruled a decision of the Food and Drug Administration (FDA) on the over-the-counter (OTC) status of emergency contraception. What will be the repercussions of Secretary Sebelius’s action? Why is the act itself of far greater long-term significance than the transitory regulatory action it impacts? By reversing an FDA decision, the Secretary has set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services (HHS) and the White House on any and all FDA decisions—directly inserting politics into what must be a scientifically driven process.
American Epilepsy Society (AES): Written Comments to Norman E. “Ned” Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA), Department of Health and Human Services (HHS)
