Industry/Patient Alliance Says REMS Bills Spur Liability, Diversion

Concerns over Risk Evaluation and Mitigation Strategies (REMS) abuse are largely misinformed and current reform proposals would create liability and diversion concerns for brand drug makers, an alliance of pharmaceutical companies and patient advocacy organizations argues in recent comments to FDA. But a generic drug source argues that the criticisms by the coalition, Aimed Alliance, are false and should be dismissed if “we trust the FDA to do their job.” FDA Commissioner Scott Gottlieb has spoken out against alleged abuses...