FDA Nominee Gottlieb on Human-Relevant Tests to Improve Speed, Safety, Cost

Congress held confirmation hearings last week for Food and Drug Administration commissioner nominee Scott Gottlieb, M.D., who was asked about how to improve speed, safety, and costs in the drug development process. New technologies are often based on human cells and tissues instead of animals.

On Tissue Bioprinting

When asked about tools like tissue bioprinting, a human-relevant method that could help reduce or replace animal testing, Dr. Gottlieb responded that anything that can be done to make the drug development process more predictable—better tools to evaluate safety and effectiveness and bring down cost—should be considered. He says this is one place where we can “have our cake and eat it, too.”

On Regulatory Science

Dr. Gottlieb said that it is a challenge and opportunity to make sure that the FDA has the best training and tools, and is forward-leaning in adopting the best science into the principles used to govern the review process. He said that improving the quality of tools used by the FDA to test drugs, while still meeting FDA's high bar for safety and efficacy, would be a priority.