Online Program

278873
Comparing drug and chemical evaluation frameworks: Improving strength and transparency


Wednesday, November 6, 2013 : 8:30 a.m. - 8:50 a.m.

Mary A. Fox, PhD, MPH, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
Keeve Nachman, PhD, MHS, Center for a Livable Future and Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
Kevin Fain, JD, MPH, Department of Epidemiology and Center for a Livable Future, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
Tyler Smith, Center for a Livable Future and Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
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.

Learning Areas:

Conduct evaluation related to programs, research, and other areas of practice
Public health or related public policy

Learning Objectives:
Identify agencies responsible for toxicity reviews for drugs and chemicals Describe the role of toxicity evaluation programs in public health protection Discuss implications of differences in toxicity review procedures

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a co-investigator on this work to compare approaches to toxicity assessments for chemicals and drugs. My expertise is in human health risk assessment.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.