NORD joined a coalition of nonprofit advocacy organizations, technology developers and patient interest groups, led by the Center for Responsible Science (CRS), in calling for the FDA to update regulations that govern preclinical drug and device development. The coalition filed an FDA Citizen Petition with the aim to streamline drug and device development to ensure safer and more effective medical products are available to patients. According to Dr. Robert Coleman, science adviser 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.
For example, 95 percent of drugs found safe in preclinical test 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 coalitions’ representative. “We believe FDA will view this petition as a worthwhile project that is consistent with the FDA’s initiative to advance regulatory science.” Read the press release here.
