Beltway Roundup
Changes at FDA
Capitol Hill Action
Seth A. Mailhot, Counsel, Nixon Peabody LLP,
Leader of Nixon Peabody’s FDA Regulatory Practice Team
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
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
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.
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.
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
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
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
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.
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.”
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.”
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.”
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.
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
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
Questions?
Seth A. Mailhot
Counsel
401 9th Street NW
Suite 900
Washington, DC 20004-2128
(202) 585-8196
smailhot@nixonpeabody.com