Ex-FDA Deputy Comm warns on future R&D

New controls on access and eventually pricing of specialty drugs, allegedly under preparation by the Democrat majority in both chambers of the US Congress, will stifle pharmaceutical innovation, according to a former US Food and Drug Administration Deputy Commissioner. The proposed regulations would be introduced next year in the event of a victory for Senator Barack Obama (Democrat, Illinois) in the November 4 presidential election.

Scott Gottleib, formerly an FDA official and now a resident fellow at a conservative think-tank, the American Enterprise Institute, claims that research-based drug firms are already exiting some disease areas, such as cardiovasculars, in part due to a tougher regulatory environment. He described the Democrats' policy, in a Wall Street Journal article, as "based on a view of medical care as a commodity to be purchased at the lowest price with little allowance for innovation."