Comparing drug and chemical evaluation frameworks: Improving strength and transparency

Despite the important role they play in regulation and public health decision-making, little scholarship exists on the work of toxicity evaluation programs that characterize risks of commercial chemicals, pesticides, and human and veterinary drugs. These types of chemicals are regulated by different agencies and offices of the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) under different legal authorities. Varying authorities and processes may lead to inconsistencies in evaluation of these compounds. We aimed to characterize and compare methods used by CDC, FDA and EPA in evaluation of drug and chemical toxicity in order to foster improved rigor, timeliness and transparency in program products and related regulatory decision-making. We developed a study framework aimed at gathering information about program-specific procedures related to data collection and use, treatment of confidential business information, peer review, updating, and accessibility of program products. We conducted document review and interviews with program officials to complete the framework, then summarized and compared approaches used by each program. We found that procedures differ widely across the examined programs, which may impact confidence in and utility of toxicity assessments. Based on these concerns, we developed recommendations that focus on best practices for confidential business information, updating and accessibility, and aligning peer review processes to facilitate timely and transparent completion of toxicity assessment activities. Continuing work will emphasize exposure and risk evaluation procedures to assess health protection afforded by each program.