Sen. Coburn Plays It Safe; FDA Will Review Medical Marijuana But Not RU-486
Executive Summary
A path to federal legalization of state-sanctioned medical marijuana was approved by the Senate Health, Education, Labor and Pensions Committee as part of the markup of a bill renewing FDA's user fee program
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GAO report confirms appropriate FDA action on RU-486
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)
GAO report confirms appropriate FDA action on RU-486
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)
Rx Safety Triggers Tighten As Senate Continues Work On FDA Revitalization Act
Provisions that specify which information will trigger the requirement for a drug to have a Risk Evaluation and Mitigation Strategy have been added to the FDA Revitalization Act as Senate floor debate on the bill continues