FDA Stakeholder Update – March 8, 2019

Dear Colleague, FDA’s Stakeholders Engagement Team works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. A few notable items were issued this week, including:

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products.We’re at a critical point for the future of biosimilars in the U.S. Millions of American patients stand to benefit from increased utilization of these lower-cost, high-quality products. At the FDA, we’re committed to helping patients realize the public health benefits of a robust, competitive market for biosimilars. (March 7, 2019) USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry. The FDA announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry. FSIS and FDA released a formal agreement to address the regulatory oversight of human food produced using this new technology. (March 7, 2019) FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan. As the number of children using e-cigarettes remains at epidemic levels, our enforcement work has been one cornerstone of our efforts to protect youth from the dangers of tobacco products. (March 4, 2019) FDA's Critical Role in Ensuring Supply of Influenza Vaccine. The flu vaccine you get at your doctor’s office or pharmacy is the year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts. Consumer Update. (Updated: March 1, 2019)

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