Beltway Roundup Changes at FDA Capitol Hill Action

1. Beltway RoundupChanges at FDACapitol Hill Action Seth A. Mailhot, Counsel, Nixon Peabody LLP,Leader of Nixon Peabody’s FDA Regulatory Practice Team

2. Developments on Capitol Hill • Rep. Henry Waxman becomes Chairman of the powerful House Energy and Commerce Committee, taking the position from veteran Rep. John Dingell • Government Accountability Office issues report in June on the shortcomings in FDA's premarket review, postmarket surveillance, and inspections of device manufacturing establishments

3. Developments on Capitol Hill (cont'd) • House Energy and Commerce Committee investigation into allegations by FDA device scientists leads to departure of CDRH Director Daniel Schultz in August • FDA publishes a report in September describing the ‘extreme’ political pressures by four New Jersey congressmen that impacted clearance of ReGen Biologics Menaflex device

4. Proposed / Pending Legislation • Medical Device Safety Act of 2009 • Bill would overturn the 2008 Supreme Court decision Riegel v. Medtronic, which bars common-law claims challenging the safety and effectiveness of PMA approved medical devices. • Food and Drug Administration Globalization Act of 2009 • Bill would overhaul the FDA inspection process for foreign food, drug, device and cosmetic manufacturers, and would require the payment of an annual user fee to fund foreign inspections.

5. Proposed / Pending Legislation (cont’d) • The Drug and Device Accountability Act of 2009 • Bill would require payment of user fees to fund foreign and domestic inspections, would expand the FDA’s authority, including new subpoena powers, and require certification of premarket applications and establish civil and criminal penalties for false or misleading certifications.

6. New Faces at FDA • Commissioner of Food and Drugs, Margaret A. Hamburg, M.D. • Dr. Hamburg graduated from Harvard Medical School, and completed her residency in internal medicine at New York Presbyterian Hospital-Weill Cornell Medical Center • Former Commissioner of the New York City Department of Health and Mental Hygiene • Vice President and Senior Scientist for Biological Programs at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons

7. New Faces at FDA (cont'd) • Principal Deputy Commissioner, Joshua M. Sharfstein, M.D. • Graduate of Harvard Medical School, a graduate of the combined residency program in pediatrics at Boston Children’s Hospital and Boston Medical Center, and a graduate of the fellowship in general pediatrics at the Boston University School of Medicine • Former Commissioner of Health for the City of Baltimore • Served as minority professional staff of the Government Reform Committee of the U.S. House of Representatives for Congressman Henry A. Waxman • Information suggests that Dr. Sharfstein will play a more active role in management operations than past Principle Deputy Commissioners

8. New Faces at FDA (cont'd) • Peter G. Lurie, M.D., M.P.H. • Appointed to FDA’s Office of Policy, where he will help develop strategies to facilitate medical product availability to meet critical public health needs, reporting to the Assistant Commissioner for Policy • Dr. Lurie was most recently the Deputy Director of Public Citizen’s Health Research Group and is an adjunct faculty member at Johns Hopkins Bloomberg School of Public Health and the George Washington University School of Public Health and Life Sciences

9. Old Faces Back at FDA • Counselor to the Commissioner, John M. Taylor, III • A new position in the Office of the Commissioner with the role of overseeing FDA’s crisis response functions and advising the Commissioner on a range of policy and regulatory matters. • Mr. Taylor served previously with FDA as a staff lawyer, an advisor to previous Commissioners, and as Associate Commissioner for Regulatory Affairs. Mr. Taylor’s father also served at FDA in a variety of positions, including Associate Commissioner for Regulatory Affairs. • He most recently was Executive Vice President, Health, at the Biotechnology Industry Organization, after serving as a Divisional Vice President for Federal Governmental Affairs at Abbott Laboratories.

10. Changes at FDA • FDA hires over 1,300 new staff, with additional staff continuing to be hired • Reorganization of the Office of the Commissioner • Adds a new Office of Budget, among other changes • Commissioner Hamburg: “Our program directors have been concerned for some time that we must be more successful in aligning our budget commitments with measurable outcomes. . . . I intend to make the development and presentation of the agency's funding needs and performance goals among my highest personal priorities.”

11. Changes at FDA (cont'd) • New authority over tobacco products granted through the Family Smoking Prevention and Tobacco Control Act of 2009 and the creation of the Center for Tobacco Products • New enforcement / compliance policies announced by Commissioner Hamburg in August • Commissioner Hamburg: “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible.”

12. Changes at CDRH • Departure of Center Director Schultz leaves a critical vacancy at an important moment for CDRH • Commissioner Hamburg: CDRH was “clearly troubled.” “We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures, including making sure we have a robust internal review process.” • Is Acting CDRH Center Director Jeffrey Shuren a lock for the job? • Deputy Commissioner Sharfstein: “Dr. Hamburg and I very strongly support Dr. Shuren's leadership and his initial agenda for the center.”

13. CDRH Acting Center Director Jeffrey Shuren • Dr. Shuren was most recently the Associate Commissioner for Policy and Planning at the FDA, directing the Agency’s Office of Policy and Office of Planning. • Dr. Shuren received his medical doctorate degree from Northwestern University and his juris doctorate degree from the University of Michigan. He is board certified in Neurology, and served as an Assistant Professor of Neurology at the University of Cincinnati. • Dr. Shuren has worked in various policy positions at the FDA, as well as serving as the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.

14. Review of the 510(k) Process • FDA has commissioned the Institutes of Medicine for a $1.3 million study of its 510(k) pre-market approval system for medical devices • Study is scheduled to be completed in March 2011 • Questions to be answered: • Does the current 510(k) process optimally protect patients and promote innovation in support of public health? • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process? • CDRH will also conduct its own internal investigation of the 510(k) system

15. Other Priorities at CDRH • Additional short-term CDRH priorities: • Create an internal task force on the use of science in regulatory decision-making • Develop an effective compliance strategy • Optimally integrate premarket and postmarket information • Increase transparency in decision-making • Establish clear procedures to resolve differences of opinion within the agency

16. Questions?

17. Seth A. MailhotCounsel 401 9th Street NWSuite 900Washington, DC 20004-2128(202) 585-8196smailhot@nixonpeabody.com