A former senior consultant for the US Food and Drug Administration (FDA) charges in the latest issue of the British Medical Journal that the agency may be inappropriately influenced by patient groups and the drug industry in making decisions that affect Americans’ health and safety.
Dr. Paul Stolley was engaged by the FDA in 2000 to look into reports of adverse events associated with GlaxoSmithKline’s irritable bowel syndrome drug Lotronex (alosetron). He claims that the agency appeared to buckle under pressure from patient groups in deciding to return the drug to the market after it had been withdrawn due to safety issues.
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