GAO Draft Report Finds Plan B Rejection “Unusual”; Lawmakers Urge Decision
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
Plan B Comment Review Concerns Prompt Request For Second GAO Report
A request by Democratic Sens. Hillary Clinton (N.Y.) and Patty Murray (Wash.) for a GAO investigation into FDA's outsourcing of public comment review for Plan B is the latest effort by the lawmakers to encourage a decision on the Rx-to-OTC switch application
FDA Topsiders Must Testify In Plan B Case – Judge
The Center for Reproductive Rights will be allowed to take depositions from certain FDA "senior decision-makers" in their suit against the agency over decisions related to emergency contraceptive Plan B
FDA Comes Under Fire From Sen. Clinton Over Plan B Decision
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