Roundtable Discussion with the FDA and CMS

From Approval to Coverage: The Regulator’s Role in Enabling Evidence-Based Healthcare for the Aging Population

Convened by the Alliance for Aging Research, this expert roundtable provided an opportunity for leaders from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) and CMS’ Center for Clinical Standards and Quality to discuss their respective roles in the path from approval to national coverage of medical products. The program examined the scientific basis for approval and use of medical products for older Americans; standards for evidence generation in the pre-and post-market and pre-and post-coverage environments; and how information developed at each stage can improve patient access and optimize care.

Scott LaGanga, MBA (Moderator)

Scott LaGanga serves as vice president of public affairs and alliance development at the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading innovative biopharmaceutical research and biotechnology companies. In this role, he leads a team responsible for third-party stakeholder relations and coalition development, which includes frequent outreach to patient groups, health care providers, business leaders, organized labor, venture capitalists and academic institutions. Additionally, Scott is a member of PhRMA’s executive team and helps manage global public policy issues on behalf of the organization.

In addition to PhRMA, Scott serves as executive director of the Partnership for Safe Medicines (PSM), a public private-partnership of more than 75 organizations dedicated to combating counterfeit and unsafe medicines around the globe. In this capacity, Scott has led the development of the annual PSM Interchange forum, which brings together public and private-sector leaders, including frequent participation by Food and Drug Administration Commissioner Margaret Hamburg. In late 2010, he successfully launched PSM’s first international partnership, PSM India, as well as PSM China in late 2012.

Prior to joining PhRMA, Scott was executive director and co-founder of the Property Rights Alliance, a Washington, D.C.-based advocacy organization dedicated to the protection of physical and intellectual property rights, both domestically and worldwide.

Scott completed a master’s of business administration at George Washington University in 2009, with concentrations in international business and management. As a Henry J. Raimondo Fellow at the Eagleton Institute of Politics, Scott received a master’s degree in public affairs and politics from the Edward J. Bloustein School of Planning and Public Policy at Rutgers University. He holds a Bachelor of Arts degree in political science from the University of Maryland, College Park.

Shari M. Ling, MD (Panelist)

Dr. Shari M. Ling is currently the Centers for Medicare and Medicaid Services (CMS), Deputy Chief Medical Officer serving in the Center for Clinical Standards and Quality (CCSQ), responsible for assisting the CMS Chief Medical Officer in the Agency’s pursuit of higher quality health care, healthier populations, and lower cost through quality improvement. Dr. Ling long-standing focus is on the achievement of meaningful health outcomes through delivery of high quality beneficiary-centered care across all care settings, with a special interest in the care of persons with multiple chronic conditions and functional limitations, and reducing health disparities.

Dr. Ling has served as the lead coordinator and facilitator of the CCSQ Measures Forum. Dr. Ling represents CMS on the Health and Human Services (HHS) Multiple Chronic Conditions workgroup, and the National Quality Forum Measures Application Partnership Post-acute Care/Long-term Care workgroup, and chairs the Measures and Data sources sub-workgroup for the HHS Action Plan for Healthcare Associated Infection (HAI) Prevention in Long-term Care facilities. Dr. Ling also serves as the clinical sub-group lead for the HHS National Alzheimer’s Project Act.

Dr. Ling is a Geriatrician and Rheumatologist who received her medical training at Georgetown University School of Medicine where she graduated as a member of the Alpha Omega Alpha Honor Society. Dr. Ling received her clinical training in Internal Medicine and Rheumatology at Georgetown University Medical Center, and completing Geriatric Medicine studies at Johns Hopkins University., remaining on faculty at Johns Hopkins for 5 years, after which she joined the Intramural Research Program of the National Institutes of Health at the National Institute on Aging as a Staff Clinician for 8 years studying human aging and age-associated chronic diseases with attention to musculoskeletal conditions and mobility function.

Dr. Ling continues to serve as a part-time faculty member in the Division of Geriatric Medicine and Gerontology at Johns Hopkins University School of Medicine, and in the Division of Rheumatology, Allergy and Clinical Immunology at the University of Mary-land. Dr. Ling volunteers at the Veterans Administration Medical Center in Baltimore. She is a Gerontologist who received her training in Direct Service from the Ethel Percy Andrus Gerontology Center, at the University of Southern California, and served as the co-director of the Andrus Older Adult Counseling Center.

Dr. Ling resides in Maryland, is married and has two children.

Mark McClellan, MD, PhD (Panelist)

A doctor and economist by training, he also has a highly distinguished record in public service and in academic research. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. These include the Medicare prescription drug benefit, the FDA’s Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. Dr. McClellan chairs the FDA’s Reagan-Udall Foundation, is co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine, and is a research associate at the National Bureau of Economic Research. He previously served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House, and was an associate professor of economics and medicine at Stanford University.

From time to time, McClellan advises U.S. government officials on health care policy issues. In his capacity as a health policy expert, he is the co-director of the Bipartisan Policy Center’s Leaders’ Project on the State of American Health Care; co-chair of the Robert Wood Johnson Foundation Commission to Build a Healthier America; and chair of the FDA’s Reagan-Udall Foundation. McClellan is also co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine of the National Academy of Sciences, and is a research associate at the National Bureau of Economic Research.

McClellan holds an MD from the Harvard University–Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology, a PhD in economics from MIT, an MPA from Harvard University, and a BA from the University of Texas at Austin. He completed his residency training in internal medicine at Boston’s Brigham and Women’s Hospital, is board-certified in Internal Medicine, and has been a practicing internist during his career.

Jeff Shuren, MD, JD (Panelist)

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; and, 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.

Tamara Syrek-Jensen, JD (Panelist)

Tamara is the Director of the Coverage and Analysis Group (CAG) in the Centers for Clinical Standards and Quality at CMS. The Coverage group develops, interprets, communicates, and updates evidence based national coverage policies. These policies help provide timely access to reasonable and necessary services and technologies to improve health outcomes for Medicare beneficiaries. Before becoming the director of CAG in March 2014, Tamara was the Deputy Director. Tamara has been integral in creating coverage with evidence development (CED), an initiative that allows for Medicare coverage while developing evidence through clinical trials and registries. Under the CED paradigm, CMS is collaborating with NIH and AHRQ on a variety of research topics.

Tamara has also led CMS collaborations with FDA, including the 2010 memorandum of understanding and the ongoing parallel review pilot program. As part of the CAG leadership team, she has been part of changing the local coverage decision (LCD) paradigm to create collaborative local decisions and completed several rules updating and creating the screening and preventive benefits within the prescribed statutory or regulatory timeframes.

Prior to working at CMS, she worked as a legislative assistant for the U.S. House of Representatives. Tamara is an attorney, licensed in Maryland.

Janet Woodcock, MD (Panelist)

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; and 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.