How Drug Cos. Can Minimize Risks Of 'Right To Try' Laws

Law360, New York ( June 30, 2015, 12:02 PM EDT) -- Drug and biologic developers have faced increasing pressure from patients and their advocates to make investigational drugs available for compassionate use prior to approval by the U.S. Food and Drug Administration. Over the past year social media campaigns have spotlighted patients seeking early access to potentially life-saving treatments, drawing attention to the growing debate between patient advocates promoting wider access to investigational drugs and those urging more cautious approaches. Propelled by the plight of critically ill patients desperately seeking new treatments, several states have passed laws giving patients the "right to try" investigational drugs or biologics. The FDA has also taken steps to make its "expanded access" process more user-friendly and the agency continues to solicit input from patient groups on risk-benefit analysis and available treatments as part of its Patient-Focused Drug Development Initiative....

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