Will December 7th, 2011, be a day that will live in regulatory infamy?
That’s when 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.
By reversing an FDA decision, the Secretary set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services and the White House on any and all FDA decisions—directly inserting politics into what must be a scientifically driven process.
"Should the HHS Decision to Overrule FDA on Plan B be Reversed?" is addressed head on in the latest issue of the Food and Drug Law Institute’s Policy Forum (Volume 2, Issue 1, January 11, 2012).
I think it’s a timely and provocative read. (After all, I wrote it.)