The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a bill that would loosen current Risk Evaluation and Mitigation Strategies (REMS) requirements, was not included in Congress’s recent budget agreement. REMS are safety restrictions required by the U.S. Food and Drug Administration for medications that treat an otherwise unmet clinical need but also carry risks of serious harm if not properly mitigated. The CREATES Act encourages litigation if brand and generic drug manufacturers cannot agree on the same REMS program, leading some to argue that the bill would be a boon for trial attorneys. The news is welcome to those who are concerned that the legislation could expose the public to drugs that are not safeguarded by equally strong REMS controls. Read more here.