Prof. Ralph Hall Interviewed on Medical-Device Legislation
OCTOBER 31, 2011—The first of two podcasts featuring Law School Professor Ralph Hall is available on Medical Progress Today, the blog of the Manhattan Institute for Policy Research. Hall is interviewed by Paul Howard, Ph.D., director of the Manhattan Institute's Center for Medical Progress, about the FDA's regulation of medical devices and recently proposed legislation to improve the system.
Hall has done extensive research on the FDA 510(k) process to evaluate the safety and efficacy of new medical devices before they are released to the public. He has presented his findings to the Institute of Medicine and in February discussed them before the House Energy & Commerce Committee's Subcommittee on Health.
Recently Hall has been working closely with members of the U.S. Senate Committee on Health Education, Labor & Pensions and others, including Minnesota Rep. Eric Paulsen,
co-chair of the House Medical Technology Caucus, on legislation to improve the FDA's medical-device clearance process.
Congress is trying to address several challenges, Hall said. The current system lacks predictability and timeliness, requirements are unclear and sometimes change midstream, the process is complicated by excessive nonvalue-added regulatory activity, and resources are not used effectively.
Proposed legislation aims to modify the process to, for example, ease the burden on new-device companies, many of which are small, start-up companies. "The research behind these products is often very extensive and very expensive," Hall said, and prolonged premarket evaluation can drive them out of business.
Among the new legislation are the Premarket Predictability Act of 2011 and the Novel Device Regulatory Relief Act of 2011, both of which are amendments to the Federal Food, Drug, and Cosmetic Act. "These are efforts to improve the system, not to start again," Hall said.
Hall has been invited to participate in a Nov. 9, 2011, Congressional briefing on medical-device issues by the Manhattan Institute. The nonprofit organization was formed more than 30 years ago to support research on important public policy issues.
To hear the entire interview, go to www.medicalprogresstoday.com/podcasts. Part 2 will be available soon.