Friday, October 17, 2014
10:00 am-11:30 am
Location: Rayburn 2322
Please RSVP to Anthony Curry at firstname.lastname@example.org if you plan to attend.
The FDA 101 briefing provides a basic background on the United States Food and Drug Administration (FDA), particularly focusing on the agency’s responsibilities for regulating and promoting the development of products that account for more than 20% of consumer spending. Participating congressional staff will gain a comprehensive picture of the basic structure of FDA regulation, the complex public health challenges the FDA is facing, and perspectives on the importance of FDA’s work from regulated industry, patient and consumer groups. The briefing is designed for congressional staff who have healthcare policy responsibility or have an interest in learning more about the agency.
FDA’s Deputy Commissioner for Policy, Planning, and Legislation will start the briefing with a presentation on the agency’s mission and responsibilities and discuss some of the critical challenges and priorities FDA is currently working to address. Next, panel participants will discuss FDA’s important role from the perspective of their organizations. Panel participants include the CEO of a leading biotechnology company, the director of food safety at a major consumer advocacy organization, a senior leader of a patient organization, and a leading advocate within the food and beverage industry.
Sally Howard, Deputy Commissioner for Policy, Planning, and Legislation, United States Food and Drug Administration
Sally Howard is the Deputy Commissioner for Policy, Planning, and Legislation for the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). In that capacity, she plays a critical role in overseeing the development and implementation of key policy initiatives, the formulation and tracking of strategic priorities, and the Agency’s engagement in Congressional activities. Immediately prior to joining FDA, Ms. Howard was in the Office of the Secretary at HHS, where she served as the Chief of Staff since April 2011. Prior to serving as Chief of Staff, she held other senior positions including Acting General Counsel and Deputy General Counsel. In those positions, she provided legal guidance to leadership across HHS on many issues of critical importance to the department. Before joining HHS, Ms. Howard served as Chief Counsel to the Office of Kansas Governor Mark Parkinson and former Governor Kathleen Sebelius. During her tenure, she provided legal counsel to the Governor on a wide array of issues and policy initiatives and worked with the Kansas Attorney General and executive agencies across the state on significant litigation. She also previously served as Chief Counsel to the Kansas Department of Transportation. In this capacity she provided legal counsel to the Secretary, worked on significant legislation for the department, and managed complex litigation.
Rachel King, Chief Executive Officer, GlycoMimetics
Rachel King is CEO of GlycoMimetics, a clinical-stage biotechnology company that uses novel and proprietary glycobiology technology to develop treatments for diseases particularly where there is high unmet need. Before co-founding GlycoMimetics, Mrs. King was an Executive in Residence at New Enterprise Associates (NEA), one of the nation’s leading venture capital firms. Mrs. King came to NEA after serving as a Senior Vice President of Novartis Corporation. Before joining Novartis, Mrs. King spent ten years with Genetic Therapy, Inc. (GTI), a biotechnology company, where she served in a number of roles as part of the executive team, through that company’s initial public offering and later acquisition by Novartis. After the acquisition by Novartis, she served as CEO of Genetic Therapy, which was then a wholly owned subsidiary of Novartis. Mrs. King also worked previously at ALZA Corporation in Palo Alto, California and at Bain and Company in Boston. She received her B.A. degree from Dartmouth College and her M.B.A. from Harvard Business School. Mrs. King currently serves as Chair of the Board of the Biotechnology Industry Organization (BIO). At BIO, she is also on the Executive Committee and is a former Chair of the Emerging Companies Governing Body. She is also Chair of the Maryland Life Sciences Advisory Board appointed by Governor Martin O’Malley.
Caroline Smith DeWaal, Food Safety Director, Center for Science in the Public Interest
Caroline Smith DeWaal is the director of the food safety program at CSPI and co-author of Is Our Food Safe? A Consumer’s Guide to Protecting Your Health and the Environment (Three Rivers Press, 2002). She represents CSPI before Congress and in the regulatory arena on a broad range of food safety issues. DeWaal is the leading consumer analyst on laws and regulations governing food safety, and she has testified more than twenty times on pending food safety issues before the United States Congress. She has participated in a number of World Health Organization consultations on food safety and is currently an expert advisor on its Integrated Surveillance of Antibiotic Resistance project. She has also participated in several national advisory committees to USDA and FDA, and was recently selected as a member of the Food Safety Modernization Act Surveillance Working Group of the Office of Infectious Diseases, CDC Board of Scientific Counselors. She represents the International Association of Consumer Food Organizations at Codex Alimentarius. DeWaal graduated from the University of Vermont and Antioch School of Law. She has taught university courses on national and global food issues.
Kristin Pearson Wilcox, Vice President, Government Relations, International Bottled Water Association
Kristin Pearson Wilcox is Vice President for Government Relations at the International Bottled Water Association. Kristin’s background includes extensive legislative and association experience in the food and beverage industry. She most recently served as vice president of government affairs at the American Frozen Food Institute (AFFI), where she managed all legislative and lobbying activities, led a variety of coalitions, and ran the political action committee and grassroots outreach campaigns. Her other areas of expertise include food labeling, food safety, health and nutrition claims, anti-obesity initiatives, environmental policy, and sustainability issues. “Kristin has extensive experience in the food and beverage industry and a strong background in federal advocacy,” said Joe Doss, President and CEO of IBWA. “This important combination of legislative experience and familiarity with the packaged food and beverage industry will allow her to effectively represent bottled water’s interests to legislators and regulators.” Along with serving at AFFI, Kristin worked for a number of other food-industry organizations, including the International Dairy Foods Association (IDFA), the National Food Processors Association (NFPA), the National Yogurt Association (NYA), National Frozen Pizza Institute (NFPI), and Frozen Potato Products Institute (FFPI). She has a B.A. in politics and U.S. history from the University of San Francisco and a J.D. from American University.
Mary Dwight, Senior Vice President, Public Policy and CF Community Affairs, Cystic Fibrosis Foundation
Mary Dwight is senior vice president for public policy and CF community affairs for the Cystic Fibrosis Foundation. She directs the foundation’s public-policy agenda and its work to support people living with CF. She has been a catalyst for accelerating the removal of barriers to clinical drug development. Dwight also leads the strategic development of the foundation’s efforts to enable and expand access to CF care. Dwight’s work encompasses the foundation’s endeavors to support people with cystic fibrosis, including the Patient Assistance Resource Center, and its CF community engagement initiatives, which strive to listen and learn from those living with the disease. Before joining the foundation, Dwight crafted policy strategy for clients such as the David & Lucile Packard Foundation, Robert Wood Johnson Foundation, First Focus and the Juvenile Diabetes Research Foundation. She began her career with Rep. Diana DeGette of Colorado, a Democratic member of the House Energy and Commerce Committee. Dwight graduated from Williams College.
The Alliance for a Stronger FDA is comprised of over 180 members, uniting a broad group of patient groups, consumer advocates, biomedical research advocates, health professionals and industry to educate policymakers regarding the importance of the FDA and its resource needs.