House committee requests GAO report on compassionate access

The U.S. House of Representatives Appropriations Committee requested the U.S. Government Accountability Office produce a report on compassionate access to investigational drugs, including a "review of how the FDA is working with all stakeholders to accelerate the approval of innovative, safe and effective medicines, and how FDA takes into account safety and efficacy data from expanded access programs." The request was added by voice vote approval of a manager's amendment to a report released by the House Appropriations Committee on Thursday. The language was included at the request of Rep. Michael McCaul (R-Texas), who said the GAO report "will guarantee a non-partisan Congressional review of the difficulties patients have obtaining life-saving treatments through Compassionate Use and by including this language in statute, it increases awareness of a great medical need that is currently unmet" (see BioCentury's continuing coverage on compassionate access). ...