Department of Health and Human Services, Commissioner of Food and Drugs

Department/Agency: Department of Health and Human Services

Position:

Commissioner of Food and Drugs

Executive Schedule: Executive Level IV - Presidential Appointment with Senate Confirmation

Major Responsibilities:

Promote and protect the public health and the safety and efficacy of the food and drug supply
Provide the public with accurate, science-based information needed to improve health
Approve new drugs and devices
Monitor drugs’ continued safety once in use
Oversees reviews of clinical research

Key Competencies and Preferred Qualifications:

Medical degree or other scientific background
Management experience
Ability to operate in highly visible position
Monitor drugs’ continued safety once in use

Insight:

The Commissioner of Food and Drugs is responsible for protecting and advancing public health by evaluating foods, drugs and other products designed for human consumption. As the director of the Food and Drug Administration (FDA), the commissioner is the public’s visible source of information on the products they use to improve and maintain their health.

The FDA’s regulation of medicines is fraught with controversy. An FDA medical officer, Frances Kelsey, was credited with keeping thalidomide off the market in the U.S. in 1962 when it was being sold in Europe as a treatment for morning sickness and causing thousands of birth defects. But several major drugs approved by the FDA in the past decade later were abruptly pulled from the market after doctors discovered serious side effects. They include the arthritis drug Vioxx, which was linked in 2004 to strokes and heart attacks.

A sharp spike in allergic reactions to the blood thinner heparin between November 2007 and February 2008 was traced to a contaminant introduced during production in China. Although the Chinese disputed the findings, they and more than a dozen other nations agreed to hold a summit on drug and drug ingredient inspections in 2009.

Several high-profile public health scares raised questions about the agency’s effectiveness. An outbreak of a rare form of salmonella in June 2008 was initially linked to red plum tomatoes, and FDA warned consumers nationwide not to eat raw red tomatoes. But the outbreak was ultimately tied to jalapeno and Serrano peppers imported from Mexico. The scare knocked tomatoes off the menu in restaurants and homes across the country, sickening more than 1,400 people and crippling many tomato farmers.

Some critics have suggested combining the FDA with the Department of Agriculture’s food safety operations to streamline the process. Better food labeling practices are also advocated. "We need better information going to the consumer so he can identify fruits and vegetables when it's in his refrigerator and in his cabinet shelves," said David Plunkett, senior staff attorney at the Center for Science in the Public Interest.

The public nature of the FDA — and its mistakes — is part of the reason past commissioners have found the post so challenging. Industry, interest groups and Congress are quick to criticize the commissioner’s decisions. Even the FDA’s main source of funding draws criticism. The FDA charges user fees to pharmaceutical companies who apply for drug approval. The pay for service plan largely funds the FDA’s operations, but critics question the wisdom of keeping a regulatory agency financially dependent on the industry it is supposed to police. Congress reauthorized the system for five years in 2007.

Even when the FDA acts against the interests of the pharmaceutical companies, it creates public enemies. The FDA denied a petition to give over-the-counter status to the emergency contraceptive Plan B, leading to accusations that then-commissioner Dr. Mark B. McClellan based the call on personal ideology and political pressure rather than scientific evidence. A coalition of reproductive rights groups launched a lawsuit in 2005 to challenge the FDA’s claims that the drug would be unsafe for young women if accessible without a prescription. McClellan denied involvement in the decision, saying he had moved on to his new job at the helm of the Centers for Medicare and Medicaid almost two months before the petition for over-the-counter status was rejected. However, others within the FDA testified that McClellan and his deputy helped kill the drug’s chances even before a full scientific review was completed. "[Deputy Commissioner Janet Woodcock] conveyed to me her assurance that this was the only way to go, to issue a non-approval letter to appease the administration's constituents, and then later this could be approved," Dr. Florence Houn, former director of the FDA Office of Drug Evaluation, testified.

The Plan B fight spilled into the lap of the next commissioner, Dr. Andrew C. von Eschenbach, whose confirmation was held up until the FDA approved Plan B as an over-the-counter drug for women over the age of 18.

Rapid advances in science increasingly demand tough calls like the Plan B decision. Eschenbach says the future of the FDA is in “peril” without some significant changes. “Growth alone would be a daunting challenge to manage, but FDA's problems have been and are further accentuated by an increasingly complex and rapidly and radically changing world whose transformation is captured in such every-day terms as ‘globalization, ‘just-in-time delivery from production to consumption,’ ‘ready-to-eat’ and ‘fresh every day’ – not to mention words like ‘bioterrorism’ and ‘pandemic,’” he told the Food and Drug Law Institute in a March 2008 speech.

A complete modernization of the FDA is necessary to avert major problems, Eschenbach said, including investing in a better-trained and equipped workforce, as well as a revamped information infrastructure.

Key Relationships – Within the Department or Agency:

Secretary
Under Secretary
Director, National Institutes of Health
Director, Centers for Disease Control
Director, Agency for Healthcare Research and Quality
Director, Alcohol, Drug Abuse and Mental Health Administration

Key Relationships – Within the Government:

Administrator, Environmental Protection Agency
Administrator, Occupational Health and Safety Administration,Department of Labor
Director, Food Safety Inspection Services, Department of Agriculture
Chairman, Consumer Product Safety Commission

Key Relationships – Outside the Government:

The Health Research Group
Joint Institute for Safety and Applied Nutrition
National Center for Food Safety and Technology
Association of Food Services, Inc.
National Grocers Association
Food Marketing Institute
National Pharmaceutical Association
Pharmaceutical Manufacturers Association
Consumer organizations
Disease associations
Industry
Academia

Nomination Referred to:

Senate Committee on Health, Education, Labor and Pensions

Current Position Profile:
1. Margaret Ann "Peggy" Hamburg, M.D. (Confirmed: May 18, 2009). Former Senior Scientist, Nuclear Threat Initiative, Inc. Former Director, Board of Directors, Henry Schein, Inc.

Recent Position Profiles:

1. Andrew C. von Eschenbach, M.D. (Acting, 2005-2006; 2006-2009). Former director of the National Cancer Institute. Former chairman of the department of urologic oncology and vice president and chief academic at the University of Texas M.D. Anderson Cancer Center. Lt. Commander in the U.S. Navy Medical Corps.

2. Lester M. Crawford, M.D.V. and Ph.D. (Acting, 2004; 2005). Former chair of the department of physiology-pharmacology at the University of Georgia. Former FDA deputy commissioner and administrator of the Food Safety and Inspection Service. Former director of the Center for Food and Nutrition Policy at Georgetown University and Virginia Tech.

3. Mark B. McClellan, M.D., Ph.D. (2002-2004). Former associate professor of economics at Stanford University and deputy assistant secretary of the Treasury for Economic Policy. Former associate professor of medicine at Stanford Medical School and Health Outcomes Research director. Board certified internist. Later administrator of the Centers for Medicare and Medicaid Services.