PhRMA: REMS Bill Poses Safety Issues, Incentivizes Stalling Negotiations

An industry attorney representing the brand-name drug lobby said a bipartisan bill designed to stop abuses of FDA risk evaluation and mitigation strategies (REMS) poses safety concerns and could incentivize generic manufacturers not to negotiate in good faith. The lawyer's comments, at a Senate Judiciary subcommittee hearing Tuesday (June 21), received stiff push back from senators on the panel, including anti-trust and competition subcommittee chair and bill cosponsor Mike Lee (R-UT). The Creating and Restoring Equal Access to Equivalent Samples...