Coalition Files FDA Petition to Broaden Testing Options in Drug Development

Advancing Regulatory Science includes allowing for the most predictive test

Washington, D.C., July 31, 2015—A coalition of non-profit advocacy organizations, technology developers and patient interest groups are calling for the Food and Drug Administration (FDA) to update regulations that govern preclinical drug and device development.

The coalition, led by Center for Responsible Science (CRS), a non-partisan, nonprofit advocating for more modern and predictive test methods in drug development, has filed an FDA Citizen Petition that aims to streamline drug and device development to ensure safer and more effective medical products are available to patients. According to Dr. Robert Coleman, science advisor to CRS and Safer Medicines Trust, FDA regulations mandate animal data, which works against its initiative to advance regulatory science. “As written, the current regulations do not provide sponsors with the option to use human-based technologies that may be more predictive of human response,” Dr. Coleman says.

While FDA has expressed concern about the poor performance of current test methods,&and has stated informally that it will accept data from human-based test methods where appropriate, 29 current FDA regulations still require animal data. The coalition claims FDA should update the regulations to bring written policy up to date with stated policy in order to pave the way for further development,&validation and use of human4based test methods.

The coalition argues the most predictive technologies in existence should be available to drug sponsors as they work to provide the safest and most effective medicines for patients.“The ultimate focus should be on which technologies work best and are most predictive, regardless of whether the data are animal based or not,” says Dr.Troy McCall, advisor to and member of the CRS Board of Directors.

The petition includes stark statistics on drug development that support the coalition’s focus on development and use of safer, more effective and less expensive preclinical test methods. For example, 95 percent of drugs found safe in preclinical tests later fail during human clinical trials due to their toxicity and/or lack of efficacy. FDA may be interested in updating the regulations because more predictive tests likely mean faster development times. “This small step for FDA will lead to more efficient drug and device development,” says Marc Scheineson, regulatory attorney with Alston Bird and the coalition’s representative. “We believe FDA will view this petition as a worthwhile project that is consistent with FDA’s initiative to advance regulatory science.”

The coalition includes: Center for Responsible Science, Asterand Bioscience, AxoSim Technologies LLC, Empiriko, Friends of Cancer Research, HµREL® Corporation, In Vitro ADMET Laboratories, InvitroCue, InVitro International, MatTek Corporation, National Organization for Rare Disorders, Safer Medicines Trust, United Spinal Association and 3D Biomatrix, Inc.