Evidentiary Standards for Drug Approvals in the 21st Century Cures Act: A Continued Trend Towards Valuing Access over Safety for Pharmaceutical Drugs

The Food and Drug Administration (“FDA”), tasked with promoting and protecting public health, has long been recognized as the gatekeeper for drugs. However, the agency has not been immune from criticism from patients and industry stakeholders over its time-consuming and clinical data-driven approval processes, alleged to hinder potentially effective drugs from reaching the market as quickly as they could. In December of 2016, the signing of the 21st Century Cures Act (“Cures Act”), a piece of “landmark” legislation that alters the rigorous approval processes for drugs by allowing data other than those derived from clinical trials into the approval process consideration, came as a triumph to these critics. These critics lauded the legislation as a win for both patient access and innovation. However, this “triumph” may come at an expense: safety. This Recent Development examines the key, relevant provisions of the Cures Act relating to the different standards of evidence required for drug approvals, and how the implementation of these provisions will impact the future of safe and effective drugs, given our current framework for drug approvals.