Speaking during the Generic Pharmaceutical Association’s annual conference in February 2013, Food and Drug Administration (FDA) Commissioner Margaret Hamburg reportedly indicated that the agency had begun collecting the funding it needs to reduce its generic drug application backlog under the Generic Drug User Fee Amendments of 2012. She cautioned, however, that the current federal budget situation and “sequestration,” a congressional budgetary impasse that will require across-the-board cuts for all federal agencies, may subject the user fees, in addition to appropriated funds, to sequestration.

Hamburg also reportedly indicated that FDA’s Center for Drug Evaluation and Research is working on creating an office of pharmaceutical quality that would enforce existing quality standards, noting that “quality is one of our highest priorities” in 2013. She further addressed the agency’s efforts to finalize the draft biosimilars guidance issued in 2012, saying that the agency was awaiting its first application and is “eager to engage in that next stage of the process.” See Bloomberg BNA Product Safety & Liability Reporter, March 4, 2013.