Chair Eshoo and Ranking Member Guthrie, thank you for the opportunity to testify before you today on neurodegenerative disease drug development and approval. I have spent a substantial portion of my medical career researching and treating disorders and diseases of the brain, and I am particularly gratified to come before this Committee for the first time in my capacity as Director of the Food and Drug Administration’s (FDA or the Agency) Center for Drug Evaluation and Research (CDER) to testify on the topic of neuroscience. Neuroscience is an area of medicine where there is tremendous unmet need for safe and effective treatments and for research that can guide the development of new therapies.

The pace of drug development in the United States has advanced to a point where FDA is steadily approving new therapies that make major improvements in the lives of patients with a wide range of diseases. In the last several years, FDA has increased the number of drugs approved that improve and prolong the lives of, or even cure, patients who suffer from devastating, and in some cases, previously fatal diseases.