FDLI's Annual Meeting Features FDA Seeking More Resources and Regulatory Authority and More (Part 1 of 2)
On April 23 and 24, 2013, the Food and Drug Law Institute ("FDLI") held its Annual Conference in Washington, D.C. As expected, FDLI's Conference featured the FDA Commissioner, Margaret A. Hamburg, M.D., presentations from leaders from all of FDA's Centers and the Chief Counsel, Elizabeth Dickinson, and leaders from industry, academia, and the legal bar. Unlike previous years, however, there were far fewer FDA attendees due to budget cuts, and FDA seemed more reluctant to use the Conference as a platform for announcing new policy or initiatives.
Hamburg kicked off the Conference with her recognition that FDA's budget was cut, along with other government agencies, noting that it would make times tight but that there are no planned furloughs. Hamburg said that this fiscal year, FDA lost about $209 million-$126 million in budget authority and $83 million in user fees. FDA will continue to collect user fees, but FDA cannot use them this fiscal year due to the sequesteration issue. Hamburg said that the reduced budget would mean reductions in programs but did not specify which ones. Yet, at the same time, Hamburg emphasized that FDA has been busy implementing its new regulatory authorities, including the new Center for Tobacco Products and authorities in the Food and Drug Administration Safety and Innovation Act ("FDASIA").
Hamburg stressed that it has become more and more apparent that its regulated industries need to build quality in their products. She highlighted that quality issues have caused two out of three drug shortages, and FDA has uncovered "shockingly unsafe drugs" at compounding pharmacies. Over the past several months, Hamburg explained, FDA has been inspecting compounding pharmacies and has found unidentified black particles in what were supposed to be sterile injectable products, rust and mold in sterile rooms, and products being processed with bare hands. At the same time, FDA has encountered increased resistance during its inspections, resulting in at least two cases needing administrative warrants. Hamburg said that FDA believes there should be a distinction between traditional and nontraditional compounding--traditional is individualized to patient; nontraditional is sterile product prepared out of state compounded and anticipated without a prescription. For nontraditional compounding, FDA has asked Congress for more clear FDA authority to monitor and examine records in the "patchwork" of compounding rules.