Department of Health and Human Services
-White Oak (campus) 10903 New Hampshire Ave.; Silver Spring, MD 20993
——
FDA was the first regulatory agency created in the United States, initially in 1906 on the passage of the Federal Pure Foods and Drugs Act known as the Wiley Act. Previously the agency was organized as a laboratory of the Bureau of Chemistry under the Department of Agriculture. Today it is a department of Health and Human Services (HHS).
—
“Mission”
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, products that emit radiation, and tobacco products.
“The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
——
FDA Leadership Profiles
—
Commissioner of Food and Drugs
Margaret A. Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive.
As the top official of the Food and Drug Administration (FDA), Dr. Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. “Strengthening FDA’s programs and policies will help us protect the safety of the food supply, give the public access to safe and effective medical products, find novel ways to prevent illness and promote health, and be transparent in explaining our decision-making,” says Dr. Hamburg. “A strong FDA is an agency that the American public can count on.”
Dr. Hamburg graduated from Harvard Medical School and completed her residency in internal medicine at what is now New York–Presbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.
From 2005 to 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to “reducing” the threat to public safety from nuclear, chemical, and biological weapons. From 2001 to 2005, as the foundation’s vice president for biological programs, she advocated for broad reforms to confront the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.
In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored.
From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene. In this position, she improved services for women and children, promoted needle-exchange programs to reduce the spread of HIV, and initiated the nation’s first public health bioterrorism defense program. Her most celebrated achievement was curbing the spread of tuberculosis, which resurged as a major public health threat in the 1990s. As a result of Dr. Hamburg’s reforms, New York City’s TB rate fell significantly over a five-year span. Her innovative approach, which included sending health care workers to patients’ homes to make sure they completed the drug regimen, is now a model for health departments worldwide.
* 12-05-09 Director Margaret Hamburg, who owns stock in Henry Shein Inc, has allowed mercury amalgam to get special approval - from Dr. Mercola www.mercola.com , http://www.youtube.com/v/aB9dY-VuSqE&color1=0xb1b1b1&color2=0xcfcfcf&hl=en_US&feature=player_embedded&fs=1″></param><param
* FDA Commissioner Margaret Hamburg must get rid of health-related holdings By Laurie Bennett | May 26, 2009
New Food and Drug Commissioner Margaret Hamburg, one of the wealthiest and most connected appointees of the Obama administration, is having to dispose of some major assets.
Hamburg and her husband, hedge fund executive Peter Fitzhugh Brown, reported an income of at least $10 million in 2008, according to financial disclosure forms filed with the White House. Brown, an expert on artificial intelligence, works with James Simons, the country’s top hedge fund earner last year.
According to the The Wall Street Journal, the couple reported assets of $21 million to $40 million (disclosure forms call for income and assets to be reported in broad ranges). They will have to divest themselves of several holdings, including pharmaceutical stocks, to avoid conflicts of interest.
Hamburg, who will make $150,000 a year at the FDA, has resigned her board position at medical supplier Henry Schein, Inc., and has sold off nearly $3 million in company stock over the past several days.
Hamburg is the former New York City health commissioner and was assistant secretary at the U.S. Department of Health and Human Services during the Clinton administration.
She is the daughter of two prominent physicians – David A. and Beatrix Hamburg.
Her father is former president of the Carnegie Corporation of New York and the Institute of Medicine. Her mother was the first African-American woman to attend Vassar and to receive a degree from the Yale University School of Medicine. Beatrix Hamburg is a former president of the William T. Grant Foundation.
http://news.muckety.com/2009/05/26/fda-commissioner-margaret-hamburg-must-get-rid-of-health-related-holdings/16111 (click to see accompanying map)
* “Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown’s inherited drug-company stocks…Mr. Brown is a lieutenant to hedge-fund magnate James Simons” http://online.wsj.com/article/SB124328188115551961.html?mod=dist_smartbrief
* Renaissance Technologies: http://www.answers.com/topic/renaissance-technologiesc3
* See http://fedupusa.wordpress.com/margaret-hamburg/ for more.
* http://www.muckety.com/Margaret-A-Hamburg/94327.muckety (see link for more connections)
Present: Nuclear Threat Initiative – VP; Rockefeller University – trustee; Sidwell Friends School – trustee; U.S. Food and Drug Administration – commissioner. “Past”: Conservation International – director; Henry Schein, Inc. – director; New York (NY) – health commissioner; Rockefeller Foundation – trustee; U.S. Department of Health and Human Services – assistant secretary
Nickname: Peggy / Peter Fitzhugh Brown – spouse, Beatrix A. Hamburg - daughter. David A. Hamburg – daughter / …lives and/or works in Washington, DC.
-Margaret A Hamburg 3415 36th St NW; Washington , DC 20016-3147 [Age: 60-64]
-Job: Margaret Hamburg Principal 3415 36th St NW; Washington , DC 20016-3147 (202) 296-4811
-Job: Rockefeller University Trustee 1230 York Ave; New York , NY 10065-6307 (212) 327-8000
-Job: Drug Strategies Board of Directors 1616 P St NW, Ste 220; Washington , DC 0036-1407 (202) 289-9070
-Job: Foundation For Aids Research Vice Chairman 120 Wall St, Fl 13; New York , NY 10005-3908 (212) 806-1600
-Job: Mary Ann Liebert Board of Directors 140 Huguenot St; New Rochelle , NY 10801-5215 (914) 740-2100
["Mary Ann Liebert, Inc Publisher of authoritative peer-reviewed journals in the most promising areas of biotechnology, biomedical research/life sciences..."]
-Job: National Health Museum Board of Directors 171 17th St NW, Ste 1200 ; Atlanta , GA 30363-1069 (404) 888-3202
-Job: Tuttnauer Services Board of Directors 25 Power Dr; Hauppauge , NY 11788-4229 (631) 582-5130
["Sterilization and Infection Control."]
******
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
Principal Deputy Commissioner
Joshua M. Sharfstein was appointed by President Obama to be the principal deputy commissioner of the Food and Drug Administration (FDA). He served as acting commissioner for Food and Drugs from March 29 to May 25, 2009.
“FDA-regulated products touch the lives of every American every day—from our toothpaste in the morning, to most of our meals, to the medications we rely on for our health,” says Dr. Sharfstein. “It is an enormous challenge but extremely rewarding to join an agency committed to the public health.”
Dr. Sharfstein is a 1991 graduate of Harvard College, a 1996 graduate of Harvard Medical School, a 1999 graduate of the combined residency program in pediatrics at Boston Children’s Hospital and Boston Medical Center, and a 2001 graduate of the fellowship in general pediatrics at the Boston University School of Medicine.
From December 2005 through March 2009, Dr. Sharfstein was the commissioner of health for the city of Baltimore. In this position, he led efforts to
* expand literacy through pediatric primary care professionals
* make the transition to Medicare Part D easier for disabled adults
* engage college students in public health activities
* increase influenza vaccination of health care workers
* expand access to effective treatment for opioid addiction
* address violence as a public health issue
Under Dr. Sharfstein’s leadership, the Baltimore Health Department and its affiliated agencies won multiple national awards for innovative programs. In 2008, Dr. Sharfstein was named a Public Official of the Year by Governing magazine.
From July 2001 to December 2005, Dr. Sharfstein served as minority professional staff of the Government Reform Committee of the U.S. House of Representatives for Congressman Henry A. Waxman.
-Josh M Sharfstein 5820 Pimlico Rd; Baltimore , MD 21209-4203 (410) 664-9511
-4 “Jobs” (City of Baltimore): http://www.whitepages.com/search/FindPerson?firstname_begins_with=1&firstname=Joshua+&name=Sharfstein&where=
******
Russell Abbott
Deputy Commissioner for Administration
Deputy Commissioner for Administration
Mr. Abbott directs FDA’s administrative management programs to assure the effective implementation of operations and the high-quality delivery of services across the agency.
Among Mr. Abbott’s responsibilities are
* working to improve human relations processes and activities
* serving as a source of expertise and advice to the commissioner on financial management accountability and budget matters
* participating in the evaluation and design of the expansion of FDA’s headquarters site.
* Mr. Abbott obtained a B.S. from Virginia Polytechnic Institute and an M.B.A. from American University.
He is the recipient of many awards including the 2006 Meritorious Executive Presidential Rank Award presented annually to high-performing federal executives for sustained extraordinary accomplishments. He also serves in a voluntary role as the chairman of the board of directors of the FedFinancial Federal Credit Union.
Mr. Abbott joined FDA in 1970 and has held many leadership positions throughout his career. He has influenced the transformation of numerous FDA administrative processes and has made operational changes that have become a standard for many organizations within the agency.
As director of the Office of Management within the Center for Drug Evaluation and Research (CDER) from 1995 to 2009, Mr. Abbott led the successful consolidation at FDA’s new headquarters in White Oak, Md., of more than 2,500 CDER employees scattered throughout the Washington D.C. metropolitan area. His proactive recruitment process resulted in a hiring surge that exceeded a very aggressive center hiring goal. In addition, he created an employee relations liaison staff to promote effective equal employment opportunity and alternative dispute resolution awareness.
Other FDA positions held by Mr. Abbott have included
* director, Office of Management for the Center for Biologics Evaluation and Research
* director, Office of Management for the Center for Drugs and Biologics
* executive officer and director of planning, evaluation and financial management for the Bureau of Biologics
* numerous staff positions in the Office of the Commissioner
Prior to his FDA career, Mr. Abbott served in the United States Army.
******
David Dorsey, J.D.
Acting Deputy Commissioner for Policy, Planning, and Budget
Acting Deputy Commissioner for Policy, Planning, and Budget
He leads the Office of Policy, Planning and Budget in
* serving as FDA’s focal point for the development, coordination, oversight, and processing of regulations, guidances, and other policy documents
* conducting economic analyses, program evaluations, and special studies
* directing overall FDA strategic, performance, and business process planning
* planning, organizing, and carrying out budgeting in support of the nationwide public health protection programs administered by FDA
Mr. Dorsey graduated from Yale Law School in 1991. He has a masters from Princeton University and a B.A. from Haverford College.
His long experience related to food and drug regulation includes serving in the following positions:
* senior counselor to the commissioner of food and drugs, April through August 2009
* detailee on Senator Edward Kennedy’s staff on the Senate Health, Education, Labor, and Pensions (HELP) Committee, covering FDA matters, January 2001 to April 2009
* attorney in FDA’s Office of Chief Counsel, focusing on food labeling, dietary supplements, medical devices, and tobacco regulation from June 1995 to January 2001
******
Murray M. Lumpkin, M.D.
Deputy Commissioner for International Programs
Deputy Commissioner for International Programs
Dr. Lumpkin is responsible for all of FDA’s international activities, including
* interactions with foreign counterpart agencies and major multinational public health organizations
* foreign confidentiality and other agreements
* foreign technical cooperation and harmonization programs
* interactions with embassies in Washington, D.C.
* activities of FDA’s Office of International Programs, including the 13 FDA foreign posts in China, Europe, India, Latin America, and the Middle East
“Americans purchase products from all over the world,” says Dr. Lumpkin. “Through our agency’s international efforts with our foreign counterparts and stakeholders to promote food and drug safety and quality internationally, we can better help protect Americans consumers while they continue to enjoy the benefits of the global marketplace. In addition, our efforts with our counterparts overseas help contribute to the overall public health of our global community.”
Dr. Lumpkin received his B.A. from Davidson College, M.D. from Wake Forest University School of Medicine, and M.Sc. from the University of London as a Fulbright Scholar. He completed a pediatric residency and pediatric infectious disease fellowship at the Mayo Clinic. He holds professional certifications in pediatrics (U.S.) and tropical medicine/hygiene (U.K.)
Dr. Lumpkin joined FDA as director of the Division of Anti-Infective Drug Products in the Center for Drug Evaluation and Research (CDER) and served in this position until 1994. From 1994 to 2000, he served as deputy center director (review management) for CDER.
He has worked in the Office of the Commissioner since late 2000 and has been a deputy commissioner since 2001. Until August 2009, he was also responsible for the oversight of the Office of Pediatric Therapeutics and the Office of Combination Products, both of which he had overseen from the time of their creation by congressional legislation in the early 2000s.
Prior to his work at FDA, Dr. Lumpkin’s professional experience included a three-year appointment as head of pediatric infectious diseases at East Tennessee Children’s Hospital, and a two-year appointment as a medical director at Abbott Laboratories.
******
Michael R. Taylor, J.D.
Deputy Commissioner for Foods, Office of Foods
Deputy Commissioner for Foods, Office of Foods
Michael R. Taylor was named deputy commissioner for foods at the Food and Drug Administration (FDA) in January 2010. He is the first individual to hold the position, which was created along with a new Office of Foods in August 2009.
Mr. Taylor is leading FDA efforts to
* develop and carry out a prevention-based strategy for food safety
* plan for new food safety legislation
* ensure that food labels contain clear and accurate information on nutrition
“I am fully committed to working with my FDA colleagues to make the changes necessary to ensure the safety of America’s food supply from farm to table,” said Mr. Taylor.
“We look forward to working in new ways within FDA and with partners in other government agencies, the consumer community, and the food industry to tackle the important challenges – and the unprecedented opportunities – we currently face.”
Mr. Taylor received his law degree from the University of Virginia and his B.A. degree in political science from Davidson College.
A nationally recognized food safety expert, Mr. Taylor has served in numerous high-level positions at FDA and the U.S. Department of Agriculture (USDA), as a research professor in the academic community, and on several National Academy of Sciences expert committees studying food-related issues.
Before returning to FDA in July 2009 as senior advisor to the commissioner, Mr. Taylor served as research professor, School of Public Health and Health Services, The George Washington University. His research agenda focused on policy, resource, and institutional issues that affect the success of public health agencies in carrying out their prevention-related missions.
Mr. Taylor served as administrator of USDA’s Food Safety and Inspection Service (FSIS) and acting under secretary for food safety at USDA. He spearheaded public health-oriented reform of FSIS, guided the development of new safety requirements for meat and poultry products, and addressed the hazard associated with E. coli O157:H7 in beef products.
Mr. Taylor began his career as a staff attorney at FDA, holding various positions including deputy commissioner for policy. He was involved in issuing regulations to address seafood safety and in carrying out nutrition labeling requirements.
Other positions held by Mr. Taylor include senior fellow, Resources for the Future; professor, School of Medicine, University of Maryland; partner, King & Spalding law firm; and vice president for public policy, Monsanto Company.
******
Ralph S. Tyler, J.D.
Chief Counsel
Chief Counsel
Mr. Tyler is a graduate of the University of Illinois (B.A.), Case Western Reserve University (J.D.), and Harvard University (LL.M).
******
John M. Taylor III, J.D.
Counselor to the Commissioner
Counselor to the Commissioner
Mr. Taylor advises the commissioner on a broad range of policy and regulatory issues. He advocates for and advances the commissioner’s priorities related to agency policies and programs.
He leads the development and management of FDA’s emergency and crisis management policies and programs. In addition, he oversees FDA’s participation in counterterrorism and emergency exercises, and the coordination of the agency’s evaluation of emergency and crisis situations.
Mr. Taylor received his law degree in 1991 from the College of William and Mary.
He started his career with FDA in 1991 and has held various positions within the agency, including
* associate commissioner for regulatory affairs, 2002 to 2005
* director of the Office of Enforcement, 2000 to 2002
* acting director of the Office of Compliance in the Center for Drug Evaluation and Research, 2000
* special assistant to the associate commissioner for regulatory affairs, 1999
* senior advisor for regulatory policy within the Office of the Commissioner, 1996 to 1999
* attorney in the Office of the Chief Counsel, 1991 to 1996
In 2007, Mr. Taylor joined the Biotechnology Industry Organization (BIO) as the executive vice president for health. From 2005 to 2007, he was divisional vice president for federal government affairs at Abbott Laboratories.
******
Assistant and Associate Commissioners
******
Jeanne Ireland
Assistant Commissioner for Legislation
Assistant Commissioner for Legislation
Ms. Ireland leads efforts to advance FDA’s legislative priorities. Her responsibilities include
* advising and assisting key FDA officials concerning legislative needs, pending legislation, and oversight activities that affect the Agency
* serving as the focal point for legislative liaison activities within FDA and between FDA, the Department of Health and Human Services, and other agencies
* advising and assisting Members of Congress and congressional committees and staffs, in consultation with the Office of the Secretary, on agency actions, policies, and issues related to legislation which may affect FDA
Ms. Ireland received a B.A. from the University of Virginia and an A.M. from the University of Chicago.
Prior to this position, Ms. Ireland served as chief public health advisor to former chairman John D. Dingell on the House Energy and Commerce Committee, where she oversaw legislative efforts to regulate tobacco, improve the safety of the food supply, and increase oversight of imported drugs and medical devices.
From 2002 to 2008, Ms. Ireland was director of public policy at the Elizabeth Glaser Pediatric AIDS Foundation, where she directed the foundation’s advocacy for expanding global HIV/AIDS prevention, care, and treatment.
From 2001 to 2002, Ms. Ireland was a fellow with the Robert Bosch Foundation in Berlin, where she focused on German work/life policies.
From 1997 to 2001, as minority staff director for the Senate Health, Education, Labor and Pensions (HELP) Committee’s Subcommittee on Children and Families, she advised Senator Christopher Dodd on child-care and health issues, including the FDA Modernization Act of 1997 and the creation of incentives for pediatric drug testing.
Prior to this position, Ms. Ireland spent four years working in a variety of positions at the Department of Health and Human Services as a presidential management fellow.
******
Michael A. Chappell
Acting Associate Commissioner for Regulatory Affairs; Deputy Associate Commissioner for Field Operations
Acting Associate Commissioner for Regulatory Affairs; Deputy Associate Commissioner for Field Operations
In addition to being the lead office for all FDA field activities, the Office of Regulatory Affairs (ORA) is responsible for imports, inspections, and enforcement policy. The office supports FDA’s product centers by
* inspecting regulated products and manufacturers
* analyzing samples of regulated products
* reviewing imported products offered for entry into the United States
* responding to public health emergencies
ORA also works with State, Local, and Tribal regulatory counterparts to further FDA’s mission by funding cooperative agreements and providing technical assistance and training.
Mr. Chappell leads a 4000-person staff at FDA’s headquarters office and dispersed throughout the United States in 5 regional offices, 20 district offices, 13 laboratories, and more than 170 resident posts and border stations.
“Each year, we conduct thousands of inspections both in the United States and abroad, review millions of imported goods, and analyze thousands of products,” says Mr. Chappell. “The products and industries we regulate become increasingly more complex. We’re continually cultivating our skills and adapting new technologies to our inspection and enforcement programs to ensure that FDA-regulated goods are safe for use.”
Previously, Mr. Chappell served as director of the Dallas District with responsibility for all FDA domestic field activities in Texas, Oklahoma, and Arkansas.
He has also served as a supervisory consumer safety officer in the Atlanta District, and as director of investigations for the Florida District. As director of investigations, he managed all field investigational programs for the district and one of the largest import operations in FDA’s Southeast Region.
Mr. Chappell began his FDA career as a consumer safety officer in Nashville, Tenn., in 1972 when FDA’s principal focus was on foods and drugs. Later, as the resident in charge of the Memphis Resident Post of the Nashville District, he was responsible for new emphasis programs for the field force in medical devices, biologics, and bioresearch.
Mr. Chappell is a graduate of the University of Alabama.
******
Beth Martino
Associate Commissioner for External Affairs
Associate Commissioner for External Affairs
Ms. Martino has a bachelor’s degree in political science, graduating summa cum laude from Washburn University. She also holds a master’s degree in journalism from the University of Kansas.
Before assuming her current position, Ms. Martino was director of communications and press secretary for Kansas Governor Mark Parkinson and former Kansas Governor Kathleen Sebelius. As the governor’s primary spokeswoman, Ms. Martino coordinated the development and delivery of the governor’s policy positions and goals to the public and media.
Ms. Martino previously served as the deputy secretary of the Kansas Department of Labor and also served as director of communications at the labor department.
Prior to her government service, Ms. Martino was an account coordinator at MB Piland Advertising in Topeka, Kan., and a district executive for the Boy Scouts’ Jayhawk Area Council in Topeka.
******
Center Directors
******
Lawrence R. Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products
Director, Center for Tobacco Products
Dr. Deyton and his center are working to
* prevent youth from using tobacco and helping adults who use to quit;
* promote public understanding of the harmful and potentially harmful constituents of tobacco products
* develop a science base for tobacco product regulation; and
* begin meaningful tobacco product regulation in order to reduce the toll of tobacco-related diseases, disability, and death
“Tobacco use is the leading cause of preventable disease, disability and death in the nation. There is no more important public health issue facing us today than tobacco use,” says Dr. Deyton. “To have a role to decrease the impact of tobacco use on the nation, on our communities, on our families, and on individuals attracted me to this position both as a practicing physician and as someone who’s dedicated my career to public health.”
Dr. Deyton is a graduate of the University of Kansas, the Harvard School of Public Health, and the George Washington University School of Medicine. He is also a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences. He received his post-doctorate medical training at the University of Southern California/Los Angeles County Medical Center and fellowship training at the National Institutes of Health.
Dr. Deyton served for 11 years in leadership positions in the National Institute of Allergy and Infectious Diseases, and six years in the Office of the Assistant Secretary for Health of the Department of Health and Human Services and as a legislative aide with the United States House of Representatives Subcommittee on Health and the Environment.
As a member of the Department of Veterans Affairs’ national leadership team, Dr. Deyton revitalized the VA’s smoking and tobacco use cessation programs. In addition to veteran’s health and environmental exposure issues, Dr. Deyton’s public health career spans the areas of HIV/AIDS research and treatment, bioterrorism, emergency preparedness, influenza, and pandemic flu. He was a founder in 1978 of the Whitman Walker Clinic, a community-based AIDS service organization in Washington, DC.
Dr. Deyton’s early public health career included tobacco control as the first full-time staff member assigned to help set up the federal Office on Smoking and Health in 1978 under then-HEW Secretary Joseph Califano.
******
Bernadette Dunham, D.V.M., Ph.D.
Director, Center for Veterinary Medicine
Director, Center for Veterinary Medicine
“We foster public and animal health by approving safe and effective products for animals and as the regulator of drugs and food additives for animals, the Center for Veterinary Medicine influences the lives of millions of animals and people each day,” says Dr. Dunham. “We are at the forefront of addressing issues such as antimicrobial resistance, genetically engineered animals, and food safety.
Previous positions held by Dr. Dunham during her tenure with CVM include: Deputy Director of CVM, Director of the Office of Minor Use and Minor Species Animal Drug Development, and Deputy Director of the Office of New Animal Drug Evaluation.
Dr. Dunham is also an Adjunct Professor in the Department of Biomedical Sciences and Pathobiology at the Virginia-Maryland Regional College of Veterinary Medicine, a position she has held since 1996.
Prior to joining FDA in 2002, Dr. Dunham was Acting Director for the American Veterinary Medical Association’s (AVMA) Governmental Relations Division in Washington, D.C. In that position, which she held from 1995 to 2002, she participated in the formation and execution of AVMA policies, objectives and programs, with emphasis on Federal legislation and regulatory issues.
From 1989 to 1995, Dr. Dunham was the Director of Laboratory Animal Medicine and Adjunct Professor of Pharmacology at the State University of New York Health Science Center in Syracuse, N.Y. She participated in a post-doctoral residency program in the Department of Pathology at the New York State College of Veterinary Medicine, Cornell University, Ithaca, N.Y., from 1987 to 1988. Dr. Dunham was a research assistant professor at Boston University from 1984 to 1987. Prior to returning to academia to pursue her Ph.D., Dr. Dunham was in private practice in Ontario, Canada from 1975 to 1979.
Dr. Dunham received the degree of Doctor of Veterinary Medicine from the Ontario Veterinary College at the University of Guelph in Ontario, Canada and a Ph.D. in cardiovascular physiology from Boston University in Boston, Massachusetts.
******
Michael M. Landa, J.D.
Acting Director, Center for Food Safety and Applied Nutrition
Acting Director, Center for Food Safety and Applied Nutrition
In this position, Mr. Landa leads the center’s development and implementation of programs and policies related to the composition, quality, safety, and labeling of foods, food and color additives, dietary supplements, and cosmetics.
Mr. Landa holds a B.A. from Columbia College, a J.D. from the University of Virginia, and an LL.M. from New York University, where he was a Food and Drug Law Institute fellow during the 1977 to 1978 academic year.
Mr. Landa’s FDA career dates back to 1978. He has held positions as deputy director for regulatory affairs in CFSAN (2004–2010), FDA’s acting chief counsel (2009–2010), FDA’s deputy chief counsel (2000–2004), and, for various periods, assistant and then associate chief counsel for enforcement, medical devices, and veterinary medicine (1978–1993).
From 1998 to 1999, Mr. Landa was a shareholder with the international law firm Heller Ehrman. From 1993 to 1998, he was of counsel and then a partner with the national law firm Fenwick & West.
From 1998 to 1999, Mr. Landa was a shareholder with the international law firm Heller Ehrman. From 1993 to 1998, he was of counsel and then a partner with the national law firm Fenwick & West.
******
Karen Midthun, M.D.
Acting Director, Center for Biologics Evaluation and Research
Acting Director, Center for Biologics Evaluation and Research
Dr. Midthun and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle. Examples of these activities include
* reviewing and providing advice during product development
* conducting research that supports product development
* evaluating applications and making approval decisions based on safety and effectiveness data
* monitoring the safety of biological products
“Biological products touch people’s lives on a daily basis with over 200 million vaccinations, 29 million transfusions of blood and blood components, and 1.6 million musculoskeletal tissue transplants each year,” says Dr. Midthun. “Many of the products we regulate are vital for the public health, such as pandemic influenza vaccines and life-saving blood products. I’m proud to lead a team whose efforts help the timely development of safe and effective products to meet these needs.”
Dr. Midthun previously served as the deputy director of CBER and the director of the Office of Vaccines Research and Review within CBER.
Before joining FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital.
Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases. She is a fellow of the Infectious Diseases Society of America and a member of the American College of Physicians and the American Society for Virology.
******
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Director, Center for Devices and Radiological Health
“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.
******
William Slikker, Jr., Ph.D.
Director, National Center for Toxicological Research
Director, National Center for Toxicological Research
Dr. Slikker and his center are working to
* advance scientific approaches and tools to promote personalized nutrition and medicine for the public
* develop science-based, best-practice standards, guidance, and tools to incorporate advancements in the study of harmful substances (toxicology) to improve FDA’s regulatory process
* conduct research and develop technologies to protect the food supply
* conduct research and development in managing and analyzing biological data (bioinformatics) in support of FDA’s regulatory mission
“Our center’s research and technical expertise are vital components of FDA’s decision-making,” says Dr. Slikker. “We provide a scientific basis for many of FDA’s food protection policies and regulatory decisions concerning medical products to improve public health.”
Dr. Slikker received his Ph.D. in pharmacology and toxicology from the University of California at Davis. He performed his postdoctoral training in the Perinatal Research Program at FDA’s National Center for Toxicological Research and at the Institute of Toxicology and Embryopharmacology, Freie Universität, Berlin.
Dr. Slikker holds adjunct professorships in the Department of Pediatrics, and the Department of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences. He has held leadership positions in several scientific societies including the Teratology Society, the MidSouth Computational Biology and Bioinformatics Society, the American Society for Pharmacology and Experimental Therapeutics, and the Society of Toxicology.
Dr. Slikker has authored or co-authored over 300 publications in the areas of transplacental pharmacokinetics, developmental neurotoxicology, neuroprotection, systems biology, and risk assessment.
Dr. Slikker is a co-founder of the International Conference on Neuroprotective Agents. He has served on national and international advisory panels including those for the Health and Environmental Sciences Institute/International Life Sciences Institute, the U.S. Environmental Protection Agency, the National Institutes of Health, the National Academy of Sciences, and the World Health Organization. Dr. Slikker is also an invited member of the Academy of Toxicological Sciences and Associate Editor for NeuroToxicology and Toxicological Sciences.
******
Janet Woodcock, M.D
Director, Center for Drug Evaluation and Research
Director, Center for Drug Evaluation and Research
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.
——
MORE BELOW
——
Centers & Offices (& see accompanying pages)
——
Center for Biologics Evaluation and Research
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
*
Center for Devices and Radiological Health
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
*
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered “drugs.”
*
Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA). FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.
The Center has over 800 employees, who range from secretaries and other support staff to highly specialized professionals–such as chemists, microbiologists, toxicologists, food technologists, pathologists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathematicians, sanitarians, physicians and veterinarians.
The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. Most Center staff members work in the Center’s headquarters in College Park, Maryland. The Center also operates research facilities in Laurel, Maryland and in Dauphin Island, Alabama.
*
Center for Tobacco Products
The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.
*
Center for Veterinary Medicine
The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)
*
National Center for Toxicological Research
The National Center for Toxicological Research (NCTR), FDA’s internationally recognized research center, plays a critical role in the FDA’s mission. NCTR—in partnership with researchers from elsewhere in FDA, other government agencies, academia, and industry—provides innovative technology, methods development, vital scientific training, and technical expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.
*
Office of Regulatory Affairs
The FDA’s Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans.
ORA staff are dispersed throughout the United States. Over 85 percent of ORA’s staff works in 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations. ORA Headquarters is comprised of the Office of Resource Management; Office of Regional Operations; and, the Office of Enforcement located in Rockville, Maryland and the Office of Criminal Investigations located throughout the United States. FDA maintains offices and staff in Washington, D.C., the U.S. Virgin Islands, Puerto Rico, and in all States except Wyoming.
Besides executing its mission through its Federal workforce, ORA also works with its State, Local, Tribal, and Territories counterparts to further FDA’s mission. ORA funds grants and cooperative agreements to perform State inspections and provide technical assistance to the States in such areas as milk, food, and shellfish safety.
——
OFFICE OF THE COMMISSIONER
COMMISSIONER OF FOOD AND DRUGS
Margaret A. Hamburg, M.D.
COMMISSIONER OF FOOD AND DRUGS
Margaret A. Hamburg, M.D.
PRINCIPAL DEPUTY COMMISSIONER
Joshua M. Sharfstein, M.D.
Joshua M. Sharfstein, M.D.
Reports to the General Counsel of HHS, advises the Commissioner of Food and Drugs
OFFICE OF THE CHIEF COUNSEL
CHIEF COUNSEL
Ralph S. Tyler, J.D.
Ralph S. Tyler, J.D.
Reports directly to the Secretary, HHS
OFFICE OF THE ADMINISTRATIVE LAW JUDGE
Daniel J. Davidson, J.D.
Reports to the Commissioner
OFFICE OF WOMEN’S HEALTH
DIRECTOR
Marsha Henderson, M.C.R.P. (Acting)
OFFICE OF POLICY, PLANNING & BUDGET
DEPUTY COMMISSIONER
David H. Dorsey, J.D. (Acting)
DEPUTY COMMISSIONER
David H. Dorsey, J.D. (Acting)
Reports to the Deputy Commissioner for Policy, Planning & Budget
ASSISTANT COMMISSIONER FOR POLICY
Leslie Kux, J.D. (Acting)
ASSISTANT COMMISSIONER FOR PLANNING
Malcolm Bertoni
ASSISTANT COMMISSIONER FOR BUDGET
Patrick McGarey, J.D.
Reports directly to the Commissioner and an indirect report to the Deputy Commissioner for Policy, Planning and Budget
OFFICE OF LEGISLATION
ASSISTANT COMMISSIONER FOR LEGISLATION
Jeanne C. Ireland
ASSISTANT COMMISSIONER FOR LEGISLATION
Jeanne C. Ireland
Reports to the Commissioner
OFFICE OF THE COUNSELOR TO THE COMMISSIONER
COUNSELOR TO THE COMMISSIONER
John M. Taylor III
Reports to the Counselor to the Commissioner
OFFICE OF CRISIS MANAGEMENT
DIRECTOR
Ellen Morrison
Reports to the Commissioner
OFFICE OF THE CHIEF OF STAFF
CHIEF OF THE STAFF
CHIEF OF THE STAFF
Molly Muldoon
Reports to the Chief of Staff
EXECUTIVE SECRETARIAT
Dotty Foellmer
OFFICE OF SPECIAL MEDICAL PROGRAMS
ASSOCIATE COMMISSIONER
Jill H. Warner, J.D. (Acting)
Reports to the Associate Commissioner for Special Medical Programs
OFFICE OF GOOD CLINICAL PRACTICE
DIRECTOR
Joanne Less, Ph.D.
OFFICE OF COMBINATION PRODUCTS
DIRECTOR
Thinh X. Nquyen
OFFICE OF ORPHAN PRODUCTS DEVELOPMENT
DIRECTOR
Timothy Cote, M.D., MPH
OFFICE OF PEDIATRIC THERAPEUTICS
DIRECTOR
M. Dianne Murphy, M.D.
Reports to the Commissioner
OFFICE OF FOODS
DEPUTY COMMISSIONER
Michael R. Taylor, J.D.
OFFICE OF THE CHIEF SCIENTIST
CHIEF SCIENTIST AND DEPUTY COMMISSIONER FOR SCIENCE AND PUBLIC HEALTH
CHIEF SCIENTIST AND DEPUTY COMMISSIONER FOR SCIENCE AND PUBLIC HEALTH
Jesse Goodman, M.D., MPH
Reports to the Chief Scientist and Deputy Commissioner for Science and Public Health
OFFICE OF COUNTER-TERRORISM AND EMERGING THREATS ASSISTANT COMMISSIONER
Boris Lushniak, M.D., MPH
OFFICE OF CRITICAL PATH PROGRAMS
DIRECTOR
Leonard Sacks, M.D. (Acting)
OFFICE SCIENTIFIC INTEGRITY
DIRECTOR
Vacant
OFFICE OF SCIENCE AND INNOVATION
DIRECTOR
Vacant
Reports to the Commissioner
OFFICE OF INTERNATIONAL PROGRAMS
DEPUTY COMMISSIONER
Murray Lumpkin, M.D.
DEPUTY COMMISSIONER
Murray Lumpkin, M.D.
Reports to the Deputy Commissioner for International Programs
ASSOCIATE COMMISSIONER
Mary Lou Valdez
Mary Lou Valdez
Reports to the Commissioner
OFFICE OF ADMINISTRATION
CHIEF FINANCIAL OFFICER
CHIEF FINANCIAL OFFICER
DEPUTY COMMISSIONER FOR ADMINISTRATION
Russell J. Abbott
Russell J. Abbott
Reports to the Chief Financial Officer/Deputy Commissioner for Administration
ASSOCIATE COMMISSIONER
Caroline Lewis
OFFICE OF ACQUISITIONS AND GRANTS SERVICES
DIRECTOR
Glenda Barfell
OFFICE OF EXECUTIVE OPERATIONS
DIRECTOR
L’Tonya Davis
OFFICE OF FINANCIAL OPERATIONS
DIRECTOR
A. Robert Miller (Acting)
OFFICE OF INFORMATION MANAGEMENT
CHIEF INFORMATION OFFICER
Lori Davis
OFFICE OF MANAGEMENT
ASSISTANT COMMISSIONER FOR MANAGEMENT
Kimberly A. Holden
Reports directly to the Commissioner and an indirect report to the Deputy Commissioner for Administration
OFFICE OF EQUAL EMPLOYMENT OPPORTUNITY AND DIVERSITY MANAGEMENT
DIRECTOR
Ricardo Grijalva, J.D.
DIRECTOR
Ricardo Grijalva, J.D.
Reports to the Commissioner
OFFICE OF EXTERNAL AFFAIRS
ASSOCIATE COMMISSIONER
Beth Martino
Reports to the Associate Commissioner for External Affairs
OFFICE OF EXTERNAL RELATIONS
ASSISTANT COMMISSIONER
Lawrence Bachorik, Ph.D.
OFFICE OF PUBLIC AFFAIRS
ASSISTANT COMMISSIONER
George A. Strait, Jr.
OFFICE OF SPECIAL HEALTH ISSUES
DIRECTOR
Theresa A. Toigo
Approved by the FDA Reorganization Coordinator and Principal Delegation Control Officer
Hello, Margaret A. Hamburg I hope you are available to come too “CITY GATE” in Coatsville, Pa.19320 located at17TH North 7TH Street Coatsville, Pa. 19320 to Inspect how the food here is being and not being served to the “HOMELESS’ men and women of this “COMMUNITY’ here in COATSVILLE, Pa. 19320 “Hope you are able too leave your office site in Washington , D.C. Margaret A. Hamburg to come and show respect for the “HOMELESS MEN and WOMEN here in COATSVILLE,Pa.19320 thank you. Hope too see you soon Margaret, Leigh
Comment by Leigh Cote — March 31, 2011 @ 8:34 am