National Policy Group Requests FDA Modernize Preclinical Testing

Health IT Now—a broad-based coalition of patient groups, provider organizations, employers, and payers that develop and advocate for policy supporting health information technology to improve patient outcomes—requested the Food and Drug Administration include preclinical innovation in implementation of the legislation 21st Century Cures.

In January 2017, Health IT Now attended a roundtable—hosted by the Physicians Committee—to discuss the need for modernizing preclinical tests. Participants included federal agencies, pharmaceutical companies, academics, technology companies, and patient, health, and research organizations. Discussions included scientific, legal, policy, educational, and training opportunities that should be addressed in order to advance the field.

The FDA requires pharmaceutical companies to test all potential new medicines in animals during preclinical tests. Preclinical tests are meant to help scientists understand how a drug will fare when given to humans. Will it be safe or toxic? Will it be effective?

While “preclinical” was once interchangeable with animal tests, the prevalence and promise of innovative, new technologies, such as organ chips, computer simulations, and 3-D bioprinting are on the rise. As Health IT states in a recent letter to the FDA commissioner, “New technologies that would allow scientists to ‘fail faster’ would reduce waste, speed up innovation, and most importantly deliver safe and effective treatments to more patients who need them.”

The legislation 21st Century Cures requires the FDA to host a public meeting and issue guidance on novel clinical trial designs. Health IT Now’s letter to the FDA commissioner requests that the FDA include preclinical innovation, as “it would be a missed opportunity for the FDA and stakeholders to not include the transformative potential of technology in the entire drug development process, including preclinical testing.”