GAO report confirms appropriate FDA action on RU-486

Executive Summary

The Government Accountability Office confirms in an Aug. 7 report that FDA's approval and oversight of Danco Laboratories' Mifeprex (mifepristone), approved in 2000 for termination of early term pregnancy, was consistent with its regulatory approach to other Subpart H restricted drugs. Members of Congress had suggested that FDA approved Mifeprex (also known as RU-486) under Subpart H outside the regulation's original purpose (1"The Pink Sheet," April 30, 2007, p. 30). After reviewing the GAO report, Senate Health, Education, Labor and Pensions Committee Ranking Member Michael Enzi, R-Wyo., said, "While FDA's actions on RU-486 may have been consistent with the agency's actions on other drugs at the time, these actions were not sufficient to protect patient safety. ... This GAO report confirms that we did the right thing in [FDAAA]." Mifeprex is one of 16 drugs retroactively deemed to require Risk Evaluation & Mitigation Strategies, and Danco will have to adhere to the new requirements by September 21 (2"The Pink Sheet," March 31, 2008, p. 7)