Larry Lesko, director of the Office of Clinical Pharmacology at the Center for Drug Evaluation and Research with the Federal Drug Administration, begins his talk by making the FDA’s commitment to personalized medicine as a public health agency. He touched on the future focus of improving drug safety and its role in future healthcare policy, citing the FDA Amendments Act of 2007.
Lesko explained that the dual mission at hand is to foster innovation and promote new initiatives under a critical path while developing and clearly articulating the standards for drugs and diagnostics. The organization takes a lifecycle approach to evidence to inform and support decisions—this goes for previous drugs and new drug development.
Moving forward, what else needs to be done? Lesko explained that ways to consensus on evidence are needed to support new drug approvals and relabeling of older drugs. He also believes that the FDA needs to develop more unambiguous drug product labels to enable actionable medical decisions and improve communication between CDER and CDRH on co-development and companion diagnostics.