People in the news

Margaret A. Hamburg

Food and Drug Administration Commissioner (since May 2009)

(FDA)

Why She Matters

In the last five years, salmonella outbreaks have seeped through America's industrial food supply; contamination in Chinese factories found its way into commonly-prescribed American drugs; and drugs from major U.S. pharmaceutical companies had to be recalled even after being declared safe by the Food and Drug Administration (FDA).

These outbreaks and breakdowns have led many to call for an overhaul of the FDA, the agency tasked with keeping Americans' food and drug supply safe. Hamburg, a bioterrorism and public-health expert, is Barack Obama's choice to be the FDA commissioner who will lead these reforms.

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Background

At a Glance

Current Position <a title="Departments/Health and Human Services/os/ds/fda" href="mks://localhost/Departments/Health_and_Human_Services/os/ds/fda">:</a> Food and Drug Administration commissioner (since May 2009)
Career History: Senior Scientist, Nuclear Threat Initiative (since 2005); Vice president of biological programs, Nuclear Threat Initiative (2001 to 2004); Assistant secretary for Policy and Evaluation, Health and Human Services Department (1997 to 2001); New York City health commissioner (1992 to 1997)
Birthday: 1955
Alma Mater: Radcliffe College, Harvard University; Harvard Medical School, M.D., 1983

Spouse: Peter Fitzhugh Brown
Office: Food and Drug Administration10903 New Hampshire AveSilver Spring, MD 20993-0002 Email N/A
Web site

Path to Power

Hamburg is the daughter of two doctors. Her mother, Beatrix, was the first African-American woman to attend Vassar College, and then the first African-American woman to earn a degree from Yale's Medical School. Her white, Jewish father, David, is a world-renowned physician.

Hamburg attended Radcliffe College, the womens' college that is now a part of Harvard University. She went on to Harvard Medical School, earning her M.D. in 1983.

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Hamburg completed her residency at the New York Hospital/Cornell University Medical Center in New York City. She also did research in neuroscience at Rockefeller University in New York and at the National Institute of Mental Health in Bethesda, Md.

Public Health Credentials

After her training, Hamburg moved to Washington, D.C., and went into public health. From 1986 to 1988, during the Reagan administration, she worked at the Health and Human Services Department in the Office of Disease Prevention and Health Promotion.

In 1988, she moved to the National Institutes of Health (NIH), where she was an assistant director at the National Institute of Allergy and Infectious Diseases. Her work there focused on AIDS research.

New York City Health Commissioner

In 1990, Hamburg left the NIH, returning to New York to serve as the city's deputy health commissioner.

In 1992, New York Mayor David Dinkins (D) made her the city's health commissioner. Hamburg held that position until 1997, introducing innovative programs to reduce the spread of AIDS and tuberculosis in New York City.

Her tuberculosis-control efforts sent health workers to tuberculosis patients' homes to ensure they took their medicines, a program that was praised and emulated around the world. During her tenure, the rate of tuberculosis infection in the notoriously-crowded city fell by nearly half, and the infection rate of some of the worst strains fell by more than 80 percent.

Hamburg's childhood immunization programs raised immunizations to record levels, and she created a clean needle-exchange program to try to stem the spread of AIDS. She also created the nation's first preparedness program aimed specifically at responding to bioterrorism.

During her tenure as health commissioner, she also held academic positions at Columbia University's School of Public Health and at Cornell University's Medical College.

In 1993, Bill Clinton asked Hamburg to tackle the newly-created post of federal AIDS coordinator. Hamburg, pregnant with her first child at the time, turned him down. Shortly after, she became the first New York City health commissioner to give birth while in office. (On her children's birth certificates, her name is printed twice, under "mother" and "health commissioner.")

In 1994, she became one of the youngest people ever to be inducted into the prestigious Institute of Medicine. Her parents had both been members since the 1970s.

Clinton Administration

In 1997, Hamburg accepted a position in Clinton's Health and Human Services Department as assistant secretary for Policy and Evaluation. She advised then-Secretary Donna Shalala on preparing for bioterrorist attacks. She stayed throughout Clinton's second term.

When Clinton left office in 2001, Hamburg moved to the Nuclear Threat Initiative, a think tank dedicated to decreasing threats from biological, chemical and nuclear weapons, and run by former Sen. Sam Nunn (Ga.), a moderate Democrat. Hamburg was vice president of biological programs from 2001 until 2004, and became a senior scientist there in 2005.

She has also been involved in the private sector. Since 2003, she's has been a director at New York-based medical equipment distributor Henry Schein, Inc.

She is married to Peter Fitzhugh Brown, an artificial intelligence expert, who is a director at Renaissance Technologies, a New York hedge fund.

The Issues

Though other candidates for FDA commissioner had more background in specific food and drug-safety issues, Hamburg's focus on public health and bioterrorism may have enabled her to avoid the usual fight between industry groups and consumer advocates that often confronts health-sector nominees in the Senate. She was sworn in by HHS Secretary Kathleen Sebelius in May 2009.

Trouble at the FDA

The FDA may have been the federal agency under the most scrutiny at the start of the Obama administration.

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The agency regulates more than $1 trillion dollars worth of goods, including food, drugs, cosmetics and vitamins. About a third of all imported goods also fall under the FDA's jurisdiction, a motley array of items from vegetables and antibodies to microwaves and cell phones.

The past few years have seen outbreaks of food-borne illnesses in disturbingly common products. Salmonella seeped throughout the country, borne on seemingly innocuous products: spinach in 2007, jalapeno peppers in 2008, and peanut butter in 2009. Sourced to just a few plants and farms, the outbreak revealed the security holes in the nation's vast industrial food system.

The global nature of the food system doesn't make things easier, with major food companies buying products from uninspected distributors around the world. In 2008, the agency traced 81 deaths in the United States to a contaminated blood-thinning drug produced in China.

After February 2009 reports that potentially-contaminated peanut butter had been shipped to state school lunch programs and used in FEMA emergency food packets, lawmakers once again asked if the FDA was capable of keeping the nation's food supply safe. Some, notably Rep. Diana DeGette (D-Colo.), even proposed the agency be split into two parts, with a food-safety agency separate from the drug-approval process.

Tobacco Regulation

Early in the Obama administration, the Senate approved a bill giving the FDA oversight of tobacco products, including the power to regulate how much addictive nicotine is added to cigarettes.

In one of the first moves to regulate tobacco, the FDA banned chocolate-, vanilla- and clove-flavored cigarettes that are believed to encourage children to start smoking.

During the first half of 2010, the FDA's Center for Tobacco Products (CTP) has been implementing the regulations to enforce FDA's new regulatory authority over certain tobacco products. They have awarded contracts to several states to assist in the training of tobacco retailers in preventing the sale of tobacco to minors, for example. With more than $400 million in user fees collected from the tobacco industry, much more is expected in the area of tobacco control from the FDA in 2011 and beyond.

Bioterrorism

Food safety issues in recent years have put a spotlight on the weaknesses in safeguarding the American food supply and its susceptibility to terrorist attack. Luckily, Hamburg has spent much of her career preparing for these problems.

"Dr. Hamburg has worked at local, national and international levels to prevent and to be prepared for bioterrorism events," Brown University's Terrie Wetle said in 2002.

In her roles at HHS, as New York City health commissioner, and at the Nuclear Threat Initiative, she has created plans to respond to everything from a bioterrorist attack to a pandemic flu outbreak. As she told a Bowdoin College audience in 2003, "a disease in a remote part of the world could be in our backyard tomorrow."

Hamburg has long advocated restructuring government agencies to make them better able to respond to a biological threat. She testified on the matter before the Senate Committee on Governmental Affairs in 2002 as part of their investigation into creating a new Department of Homeland Security.

Drug Approvals

The FDA is also facing questions about its drug-approval decisions, and the influence that wealthy pharmaceutical companies bring to bear on that process. In 2004, lucrative arthritis drug Vioxx had to be taken off the market even though it had previously been labeled as safe by the agency.

Before her nomination, Hamburg didn't have much of a track record when it came to pharmaceuticals, a fact that may have made her Senate confirmation process easier.

Baltimore Health Commissioner Dr. Joshua Sharfstein was a favorite to become FDA commissioner, and he ran the team that assessed the agency during the Obama transition. Sharfstein had made headlines in 2008 for exposing harmful children's cold medicines, and got many yanked from the shelves. Some reports say outcry from the drug lobby cost him the top job. He was named Hamburg's principal deputy at the FDA. (As a deputy, Sharfstein did not require Senate confirmation.)

The Hamburg-Sharfstein partnership could be significant. Peter J. Pitts, a former FDA associate commissioner who is president of the Center for Medicine in the Public Interest, told the New York Times that the selections could be a sign that the Obama administration wants to split the FDA into two parts.

"I think Dr. Hamburg will become the commissioner of food, since she's a safety and security person," Mr. Pitts told the Times, "and then Dr. Sharfstein would slide into the F.D.A., which would become the Federal Drug Administration."

The Network

Hamburg deputy at the FDA is former Baltimore Health Commissioner Joshua Sharfstein. She also works closely with Centers for Disease Control and Prevention head Thomas Frieden.

The late Sen. Edward M. Kennedy (D-Mass.) championed Hamburg's nomination to head the FDA.

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Additional Resources