Sen. Grassley Targets FDA's Handling Of Adderall XR Adverse Events
This article was originally published in The Pink Sheet Daily
Finance Committee chairman expresses concern that agency may have sought to dissuade Health Canada from suspending Adderall XR sales because "FDA could not handle another 'drug safety crisis.'" Grassley requests records of FDA's meetings with Health Canada.
You may also be interested in...
Office of Drug Safety Director for Science & Medicine David Graham is scheduled to present an "epidemiological overview" on Feb. 16, day one of the three-day meeting. Senate Finance Committee Chairman Charles Grassley is concerned that FDA has forbidden Graham from discussing certain data.
Company plans a "Dear Doctor" letter informing U.S. physicians of Health Canada's decision. FDA says it "has not decided to take any further regulatory action at this time"; sudden death warnings were added to Adderall XR's labeling in August.
Finance Committee Chairman Grassley’s investigation into FDA’s handling of pediatric suicidality concerns with antidepressant drugs reveals ODS “serves a subservient” role to OND. Grassley points to allegations that OND discourages recommendations in drug consults.