Health Policy Roundup: Background on FDA User Fee Programs

John Stone, J.D., principal at BGR Government Affairs, is the Co-Lead of the FDA and Public Health Working Group within BGR’s Health and Life Sciences Practice. John supports FDA-regulated clients navigate congressional and administration policy development processes that impact their products and commercial activities. John joined the firm after spending nearly seven years with the House Energy and Commerce Committee (E&C), first as a Counsel on the Oversight and Investigations Subcommittee and then as a Senior Counsel on the Health Subcommittee primarily handling issues under the jurisdiction of the FDA. John’s time with E&C was undoubtedly the busiest stretch of legislative action impacting the agency in decades. Working for former Chairman Fred Upton (R-Mich.) he played a leading role in developing, negotiating and ultimately passing numerous bipartisan bills, including the Drug Quality and Security Act (DQSA), the Safe and Accurate Food Labeling Act and the landmark 21st Century Cures Act (Cures)—widely considered one of the most comprehensive biomedical research and FDA reform bills ever signed into law. Under subsequent Chairman Greg Walden (R-Ore.), John facilitated timely passage of the Food and Drug Administration Reauthorization Act (FDARA) in the midst of a very challenging political environment. Upon John’s departure from the Committee, Rep. Upton noted that “John’s knowledge and expertise in the health care field is second to none. His contributions to our team over the years to improve the public health, particularly our 21st Century Cures effort, were immeasurable. We will miss his good nature and wise counsel. Chairman Walden added that “John has been a valuable asset at Energy and Commerce and I’m particularly glad we had him by our side leading up to and during the critical passage of the FDA Reauthorization Act earlier this year. He brings with him a tremendous wealth of knowledge and the skills to push big tasks across the finish line. Our loss is BGR’s gain.” Prior to joining the Committee in February 2011, John spent two years in the Washington office of Sanofi. He received his undergraduate degree from Miami University in Oxford, Ohio, and his law degree from American University in Washington, D.C.

Contact: jstone@bgrdc.com

Jeremy Sharp has policy experience in both the executive and legislative branches of the Federal Government. In his most recent stint in Government he served as Deputy Commissioner for Policy Planning, Legislation, and Analysis at the US Food and Drug Administration. Prior to that he served at the Department of Health and Human (HHS) Services as Counselor to the Secretary for Science and Public Health, under both Secretary Kathleen Sebelius and Secretary Sylvia Burwell. He also served as Deputy Assistant Secretary for Legislation at HHS. During his time in these roles, Jeremy worked on a variety of issues including prescription drug pricing, biosimilar and interchangeable product policy, tobacco control, substance abuse, mental health, food safety, drug and device regulation, pharmacy compounding, emergency preparedness, reproductive health and choice, health information technology, community health centers, health professions issues, blood, tissue, and organ donation, and biomedical research. Before working in the executive branch, Jeremy served as Legislative Director for Senator Christopher J. Dodd, and as one of Senator Dodd’s professional staff members on the Senate Health, Education, Labor and Pensions Committee’s Subcommittee on Children and Families. While working for Senator Dodd, Jeremy worked on the Affordable Care Act, the Family Smoking Prevention and Tobacco Control Act, and other health legislation. He also served for five and half years as Rep. Lois Capps’ senior health policy advisor and got his start working on Capitol Hill working for Sen. Evan Bayh. Between stints working for Members of Congress, Jeremy worked for the public health non-profit Trust for America’s Health.

Contact: jeremy@waxmanstrategies.com

Emilia DiSanto, J.D., is an executive vice president who brings a wealth of experience from more than three decades in federal service, both on Capitol Hill and in various federal agencies. Emilia has spent most of her career working in oversight roles, most prominently as a top aide to Chairman Charles Grassley (R-IA); for nine years she was Chief Investigative Counsel and Special Counsel to the Senate Committee on Finance, and prior to that was Chief Investigative Counsel on the Special Committee on Aging. After leaving Capitol Hill, she took a series of high-level posts in the Executive Branch, most recently as the Deputy Inspector General to the U.S. Department of State, and before that as Chief of Staff in the Federal Housing Finance Agency, where she was also the top staffer to the Inspector General. Earlier in her career, Emilia was Staff Director for the Senate Committee on Small Business. Emilia is an attorney who received her J.D. and bachelor’s degree from Fordham University.

Contact: edisanto@vennstrategies.com


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