Marc Scheineson, partner and leader of Alston & Bird’s Food and Drug Law Practice and former FDA associate commissioner for legislative affairs, provided legal and regulatory counsel on a just-published report from the Bipartisan Policy Center detailing a new regulatory pathway to promote the progress of cellular therapy in the United States.
The study, Advancing Regnerative Cellular Therapy: Medical Innovation for Healthier Americans, recommends viable policy actions that Congress can take to accelerate the availability of safe and effective cellular therapies to Americans and improve U.S. competitiveness in the global marketplace while ensuring that FDA’s regulatory framework reflects the rapidly emerging science related to cellular therapies.
Among the report’s recommendations made by a world-renown panel of scientific experts on the use of stem cells and other regenerative medicine are strengthening the rights of patients to be treated with their own cells. Such detailed policy proposals can empower physicians to treat their patients with the best available therapies and innovative techniques. It can also enable industry to support physicians and patients with safe, proven human adult cell-based technologies. To help ensure patient safety, the proposal also recommends that the premarket approval process be modified for a unique class of therapeutic cells, including the patient’s own cells and the cells of a donor that do not induce an adverse immune response.
An Alston & Bird client, the Bipartisan Policy Center is a non-profit organization and the only Washington, D.C.-based think tank that actively promotes bipartisanship across a broad range of key policy issues facing the country. It was founded in 2007 by former Senate Majority Leaders Howard Baker, Tom Daschle, Bob Dole and George Mitchell.