FDA Comes Under Fire From Sen. Clinton Over Plan B Decision
This article was originally published in The Tan Sheet
Sen. Hillary Clinton (D-N.Y.) is calling for a hearing and separate GAO investigation into FDA's decision to deny OTC approval of Barr's Plan B (levenorgestrel) emergency contraceptive
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The Government Accountability Office's investigation into FDA's initial denial of Plan B discovered that the agency's decision to issue a "not approvable" letter did not reflect the opinions of scientific review staff.
FDA Office of Women's Health Director Susan Wood is resigning over the agency's handling of Barr Labs' application to switch its Plan B emergency contraceptive over-the-counter
FDA's handling of an emergency contraception switch may be less likely to come under investigation with new leadership on the Senate HELP committee