As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. From the drug industry’s perspective, a continued stress on flexibility through the first nine months of the year could create a favorable climate for application reviews and for resolving lingering manufacturing issues.
Food & Drug Administration Commissioner Peggy Hamburg’s public image for the agency heading into 2012 is clear: FDA is a flexible regulator comfortable making positive new product approval decisions and ready to take an active role in regulatory issues affecting adequate product supply.
She touted the agency’s drug approval decision-making in a January 6 address on the state of the agency to the...