PhRMA: REMS Bill Poses Safety Issues, Incentivizes Stalling Negotiations

Safir said the bill also does not give FDA a mechanism to reject authorization of supplying the generic company with samples, revoke that authorization or suspend a study already in progress. "Since these development or bioequivalence studies may involve subjects, not even patients, who will not receive any possible benefits from these drugs the potential risks should require greater rather than lesser protections for patients," Safir said.