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| FDA Commissioner Margaret Hamburg |
After 6 years at the helm of the FDA, Commissioner Margaret Hamburg is preparing to step down. Her legacy will be a positive one in the device world, where relations between the regulator and industry are much better than when she came into office. Hamburg is credited with adding clarity to the FDA's approval processes and implementing industry-friendly initiatives like the "parallel review" pilot featuring enhanced cooperation between the FDA and the CMS. In addition, the Expedited Access Pathway for faster approval of select devices is also in the works. Hamburg also improved cooperation and outreach to international counterparts, as evidenced by the Medical Device Single Audit Program. The biggest regulatory initiative achieved under her tenure is the ongoing implementation of the Unique Device Identification system. The low point was the agency's electronic surveillance of scientists at the agency's device arm (CDRH) after they allegedly revealed proprietary information about GE's ($GE) imaging devices to The New York Times. The new deputy commissioner for medical products and tobacco, Dr. Robert Califf, is rumored to be in line to replace Hamburg. The successor will have to deal with the 21st Century Cures Initiative, an ambitious piece of planned Republican-led legislation to overhaul the government's regulation of the healthcare industry. More