On April 20-21, 2015 the Food and Drug Law Institute (FDLI) held its Annual Conference in Washington, D.C., welcoming over 600 heavy hitters from both FDA, industry, consulting, and law firms featuring FDA practices. Following opening remarks by FDLI’s President and CEO, Amy Comstock Rick, leading her first FDLI Annual Meeting, Acting FDA Commissioner Stephen Ostroff, M.D., took the stage. Ostroff said that it was his first time speaking at FDLI, day 14 as Acting Commissioner, and that he was fortunate to lead FDA after former Commissioner Margaret A. Hamburg, M.D. Ostroff highlighted FDA’s 51 new molecular entity approvals last year (17 first-in-class, two-thirds approved first in the United States and utilizing at least one accelerated-type approval program). Ostroff noted that FDA has been inspecting more, with drug compounding as an “eye-opener,” and described FDA’s approval of the first biosimilar product as a “game changer.” Ostroff said FDA will be tackling traditional animal husbandry by removing growth-promoting hormones to help prevent antimicrobial resistance. FDA will continue to consider opioid abuse and misuse, with more abuse-deterrent formulations under way. FDA will respond quickly, as additional diagnostics and measures are developed to combat the Ebola outbreaks. And FDA will continue to implement the Food Safety and Modernization Act, Ostroff said, which is “transformational,” as well as new food labeling to help consumers make better informed choices. Finally, FDA is concerned about reducing harm from tobacco product with youths, Ostroff explained, especially for some new products under consideration in the deeming rule, such as e- cigarettes.
Following Ostroff, a reactor panel noted that FDA needs to consider ways that physicians, pharmacists, and consumers can have access to more than safety and efficacy information about products. Some viewed the Center for Devices and Radiologic Health (CDRH) as overregulating, especially by some reviewers, in a world where it is increasing difficult to find predicate products to take advantage of the 510(k) clearance process. With FSMA, FDA will need to offer training for inspectors, others noted. And some questioned whether FDA has the capability to understand substantially equivalent or modified-risk tobacco products.
A second keynote by Chief Counsel Elizabeth Dickinson reinforced that FDA is well worthy of the public trust. Dickinson provided an overview of the myriad of legal issues facing FDA and her office. Dickinson noted that FDA is grappling with opioid drug abuse, determining whether FDA can withdraw a product if the primary concern is abuse or misuse, as well as removing products from the market that inappropriately claim to treat or cure Ebola. Dickinson acknowledged that FSMA is an important developing area. At the same time, FDA is struggling to move forward with the deeming regulation, which is complicated by the need to respond to the 130,000 comments received, along with a reconstituted advisory committee for tobacco products, which was disbanded due to conflict issues. FDA recognizes how preemption laws are affecting product labeling approaches, Dickinson said, and FDA is considering other options to its proposed generic changes being effected proposal—one proposed by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Generic Pharmaceutical Association (GPhA) . FDA continues to have new exclusivity issues, Dickinson observed, from the scheduling issues raised by the not so contemporaneous Drug Enforcement Agency scheduling process, and new chemical entities, as well as determining the scope of 3-year clinical data exclusivity, and the possibility for pediatric labeling carve outs from products with orphan drug exclusivity. Amidst this, FDA is ramping up for another round of user fees and associated legislative changes at FDA. For some issues, such as 180-day exclusivity, FDA continues to regulate from the statute prior to regulations, with guidances taking an increasingly important role, Dickinson said. In the world of biosimilars, FDA is considering appropriate non-proprietary names and the transition provisions for certain biologics being reclassified from NDAs to BLAs in 2020. At the same time, the Office of Chief Counsel works on random problem solving, including reviewing the presentations delivered at FDLI, Dickinson explained. Dickinson said that she would not take questions but would answer one anticipated one: “Is FDA considering the First Amendment regarding adverting, promotion, and labeling?” Answer: “Yes, we are working on it.”