FDA’S ACCELERATED APPROVAL, EMERGENCY USE AUTHORIZATION, AND PRE-APPROVAL ACCESS: CONSIDERATIONS FOR USE IN PUBLIC HEALTH EMERGENCIES AND BEYOND

May 8, 2022
NC-JOLT-Vol.-23.4_741-787_Coughlin

The Food and Drug Administration (“FDA”) continues to balance two seemingly competing goals: protecting the public from unsafe treatments and increasing the public’s access to treatments. While tensions between the goals of protection and access have ostensibly skyrocketed since the beginning of the COVID-19 global pandemic, these tensions have, in fact, been long-standing since the initial creation of the Agency. A closer examination of historic events underlying FDA’s regulatory structure, however, illustrates that the goals of safety/regulation and speedy access/individual autonomy are not and need not be considered at opposite sides of a pendulum where policymakers focus on innovative ways to generate and capture data, while also furthering safety and enabling appropriate access.

To that end, this Article reviews FDA’s approval process for drugs and biologics and delves into some events that have promoted safety within FDA’s current regulatory structure, along with events that led to the creation of alternative pathways that enable accelerated approval, emergency use authorization, and earlier access to investigational drugs and biologics both through the FDA process and through Right to Try laws, which exist outside of FDA’s purview.

This Article then turns toward the data collection imperative that is inherent in clinical research, particularly in working to end public health emergencies and preparing for future public health emergencies. This Article discusses the consequences and opportunity costs of unfettered access to investigational drugs and emphasizes the need for flexible and accessible clinical trial structures to improve participation and data generation, particularly for people of color and vulnerable populations for whom the pandemic has magnified long-standing health disparities. This Article concludes that (1) FDA’s existing alternative pathways should be scrutinized to determine if there are innovative ways to further incentivize the creation of data, as well as capture and optimize the data borne out of these uses; (2) mechanisms to increase knowledge of and access to clinical trials should be implemented to ensure sufficient enrollment that reflects the demographics of the larger patient population; and, (3) the global pandemic should be considered an opportunity to work to strengthen both safety of and access to treatment and promote diversity and inclusivity in all aspects of research, development, and treatment.

Author: Christine Coughlin

PDF: http://ncjolt.org/wp-content/uploads/sites/4/2022/05/NC-JOLT-Vol.-23.4_741-787_Coughlin.pdf

Volume 23, Issue 4