Patient Advocates Press Congress to Preserve the Integrity of the Nation’s Drug Safety System

Almost a decade after the U.S. Congress gave the Food and Drug Administration (FDA) authority to require Risk Evaluation and Mitigation Strategies (REMS) for higher risk medicines, 16 public health, patient advocacy, health professional, and disease organizations are raising concerns that proposed legislation will weaken these drug safety protections and make it easier for potentially dangerous drugs to get into the wrong hands.

In a joint letter addressed to the Senate Judiciary Committee, supporters and members of the Patients’ Alliance for Drug Safety Protections (Patients’ Alliance) cautioned lawmakers that the recently introduced Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 (S. 3056) will significantly curtail FDA’s authority to regulate high-risk drugs, including medicines that can cause severe birth defects, organ damage and even death when not carefully controlled.  While supporting the goal of the CREATES Act – to speed the development of less expensive generic drugs – the advocates expressed “significant misgivings” that as proposed, the bill will force the sale of medicines carrying serious risks to generic marketers for comparison testing while doing away with established procedures that ensure generic manufacturers adopt the same safety protocols when testing these drugs in human subjects, as well as permit separate generic REMS of unproven safety, without stakeholder input.Read Full Article Here >>