On January 30, 2014, FLH Partner Brian J. Malkin will speak at the New York State Bar Association’s (“NYSBA’s”) Annual Meeting of the Food, Drug and Cosmetic Law Section. Mr. Malkin will introduce and speak with Molly Muldoon, FDA’s former Chief of Staff, on “FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation–Perspectives from Two Former FDA Officials”. Ms. Muldoon was formerly an FDA Chief of Staff, overseeing operations and liaising with senior FDA leadership on key issues including the Affordable Care Act, Deepwater Horizon, food safety regulations and food borne outbreaks. Mr. Malkin is a former regulatory counsel at the FDA, who specializes in the strategic analysis of how policy affects FDA and IP innovation. Ms. Muldoon will discuss how effective communication, cooperation and collaboration remain critical to implement policy within FDA. She will also discuss the role of patient groups and other valuable stakeholders to work with FDA in shaping the development of FDA policies and how to achieve all of this in an increasingly political environment. In addition, the Meeting will feature the following presentations: Les Weinstein, Esq. former Ombudsman for the Center for Tobacco Products and for the Center for Devices and Radiological Health speaking on “The Role of the FDA Ombudsman–Who They Are, What They Do and How They May Assist You”; Frederick H. Fern, Harris Beach PLLC; John A. Murphy III, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America; and Irving L. Wiesen, Law Offices of Irving L. Wiesen, P.C. speaking on “Compounding Pharmacies: Regulatory Solutions to a National Health Crisis”; George J. Annas, William Fairfield Warren Distinguished Professor and Chair Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health, School of Medicine and School of Law and David S. Weinstock, LifeCell Corporation, speaking on “Ethical Conflicts in Clinical Medicine and Research: Consent to DNA Screening, Research on Extremely Premature Infants and International Drug Trials”. The Section’s meeting will conclude with its Annual Business Meeting.