Statement by Janet Woodcock, M.D., Director, Center For Drug Evaluation and Research, U.S. Food and Drug Administration, Department of Health and Human Services, before the Senate Special Committee on Aging, July 22, 2003

2003 ◽  
Author(s):  
Janet Woodcock
Keyword(s):  
Drug Administration ◽  
Human Services ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
Special Committee ◽  
Health And Human Services ◽  
Department Of Health

Should the HHS Decision to Overrule FDA on Plan B Be Reversed

2013 ◽  
Vol 19 (2) ◽  
Author(s):  
Peter J. Pitts
Keyword(s):  
Drug Administration ◽  
Emergency Contraception ◽  
Human Services ◽  
Regulatory Action ◽  
Over The Counter ◽  
White House ◽  
Health And Human Services ◽  
Department Of Health ◽  
It Impacts

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.

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