If you had any doubt that President Obama's Food and Drug Administration would take a tougher stance on regulation, you better wrap your mind around the appointment of one of the agency's toughest critics to a top policy position.
Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, will be joining the agency to work on policy, as first reported by Peter Pitts at the Center for Medicine in the Public Interest and confirmed by Forbes.
Public Citizen, founded by Ralph Nader, has been one of the loudest and most persistent critics of FDA. Lurie has been particularly tough lately on the way FDA reviews medical devices.
In testimony before a House oversight subcommittee this summer, Lurie and a colleague called upon the agency's medical device division to beef-up the science in its decision making to "reclaim its tarnished reputation for rigor."
Lurie and Public Citizen blasted FDA 's handling of an implant to repair torn knee cartilage, saying in public testimony early on, "When a device has been shown to add nothing to conventional therapy, it is hard to see how the public health (and coffers) are served by its approval."
After an internal investigation, the FDA concluded last month that the approval of the device made by ReGen Biologics raised "troubling questions" about the intrusion of politics into the agency's deliberations.
Separately, the agency reportedly has brought back John M. Taylor III, an FDA veteran, to counsel the FDA commissioner on crisis response and a bunch of of regulatory and policy issues. He'd been at the biotech trade group BIO and Abbot Labs before that.
We called and emailed FDA for info on the appointments but didn't get an immediate response.