2019 Roundtable Discussion

FDA Trends in Real-World Evidence, Digital Tech, and Modernizing Medical Device Approvals and Potential Impacts on Medical Care for Older Adults
5:15 PM – 6:00 PM

Over the past year, the Food and Drug Administration (FDA) has been pursuing an impressive agenda to update its regulatory and statutory framework to keep pace with the rapid scientific and technological changes in biotechnology. In 2018, the FDA continued to advocate for a new regulatory approach to software, released a strategic framework for the Real-World Evidence Program, and took numerous actions to modernize the 501(k)-approval pathway. Please join us for a discussion with the FDA and industry on how some of the agency’s biggest priorities will impact older adults, including its efforts to modernize the review of medical devices, incorporating real-world data in regulatory decision-making, and the future of digital health applications.

Sue Peschin (Moderator)

Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research.  The Alliance for Aging Research is dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the NIH, FDA, AHRQ, and CDC; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers.

Since 2012, Ms. Peschin has been a driving force in the growth and success of the organization. Under her leadership, the Alliance has remained strong in these priorities and continued to build on its reputation as a forward-thinking public policy and health education organization. As president and CEO, she leads the strategic development and implementation of Alliance initiatives, as well as manages Board governance and organizational operations. As a thought leader on many aging-related issues, she has led the Alliance in efforts to: boost older adult immunization rates; increase NIH Alzheimer’s disease and aging research funding; raise awareness of geriatric cardiac issues; develop a senior patient and family caregiver network through a PCORI engagement grant; and co-organize a first-ever NIH geroscience summit. She participates in major industry and policy symposiums around the country each year, and has published opinion pieces in news outlets nationwide.

Ms. Peschin currently serves on the Board of Heart Valve Voice U.S. and the National Council on Patient Information and Education; on the World Economic Forum’s Council on Human Enhancement; on the National Advisory Council for the National Institute on Aging at the NIH; on the Steering Committee for the Coalition for Imaging & Bioengineering Research; and as a member of the Lifespan Domain Task Force for the Clinical & Translational Science Award program, funded by NCATS at the NIH.

Ms. Peschin earned a B.A. in Sociology from Brandeis University, and a M.H.S. degree in Health Policy from the Johns Hopkins University Bloomberg School of Public Health.

Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.

“Our center experts and programs help get safe and effective technology to patients and health care professionals on a daily basis,” says Dr. Shuren. “Rapid technological advances enable us to approve such innovations as a diagnostic test for the H1N1 influenza virus, an expandable prosthetic rib for children with abnormal growth conditions, and a test that can help detect ovarian cancer.”

Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan.

Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.

Dr. Shuren has served in a leadership role at FDA or on behalf of the agency on numerous initiatives, including

  • reauthorization of the Medical Device User Fee Act, which dramatically shortens review times for device applications
  • creation of the Sentinel Initiative, which works toward a national electronic system for monitoring medical product safety
  • development of FDA’s Pandemic Influenza Preparedness Strategic Plan
  • development of FDA’s Counterfeit Drug Task Force Report
  • development of the Interagency Food Safety Working Report to the President
  • implementation of FDA provisions of the Medicare Prescription Drug Improvement and Modernization Act
  • development and implementation of the Interagency Import Safety Working Group’s Report to the President: Action Plan for Import Safety

From 1999 to 2000, Dr. Shuren served as a detailee on Senator Edward Kennedy’s staff on the Senate Health, Education, Labor, and Pensions Committee. From 1998 to 2003, he also was a staff volunteer in the National Institutes of Health’s Cognitive Neuroscience Section where he supervised and designed clinical studies on human reasoning.

As director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services, Dr. Shuren oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.

Janet Woodcock is the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The center makes sure that safe and effective drugs are available to improve the health of people in the United States.

Dr. Woodcock and her center:

  • evaluate prescription and over the counter drugs before they can be sold and oversee their testing in clinical trials
  • provide health care professionals and patients the information they need to use medicines wisely
  • ensure that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks
  • take action against unapproved, contaminated, or fraudulent drugs that are marketed illegally

“New drugs—and new uses for older drugs—save lives, reduce suffering, and improve the quality of life for millions of Americans,” says Dr. Woodcock. “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”

Dr. Woodcock has led many of FDA’s drug initiatives. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently.

Most recently, Dr. Woodcock launched the “Safety First” and “Safe Use” initiatives designed to improve drug safety management within and outside FDA, respectively.

Dr. Woodcock previously served as FDA’s deputy commissioner and chief medical officer. She also led CDER as director from 1994–2005. Prior to joining CDER, Dr. Woodcock oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis in her position as director of the Office of Therapeutics Research and Review in FDA’s Center for Biologics Evaluation and Research (CBER).

Dr. Woodcock received her medical degree from Northwestern University Medical School, and her undergraduate degree from Bucknell University. She has held teaching appointments at Pennsylvania State University and the University of California at San Francisco. She joined FDA in 1986.