REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission
Executive Summary
During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.
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Report sponsored by Association for Accessible Medicines in US says drugs with restricted distribution programs had total sales of $22.7bn in 2016; seven drugs had sales topping $1bn.