“Slow and burdensome” is how President Donald Trump has described the Food and Drug Administration’s drug approval process. His promise to speed it up by slashing regulations raised major safety concerns among scientists, regulators, and patient groups. But speed and safety do not have to be at odds. Modern tests that are physiologically relevant to humans because they are based on human biology — not on the biology of other animals — offer scientists more predictive information more quickly. FDA should focus on evaluating these technologies and work with industry to ensure they are implemented.
Dr. Scott Gottlieb, the new FDA commissioner, addressed the false dichotomy of speed versus safety in his congressional confirmation hearing. Through advances in regulatory science, he said that “we can have our cake and eat it too.” Gottlieb also said that the FDA should consider anything that can make the drug development process more predictive, such as better tools to evaluate safety and effectiveness and to bring down cost.