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Sources: Margaret Hamburg to Head FDA

Updated 7:15 p.m.
By Lyndsey Layton
The Obama administration has tapped Margaret Hamburg, a physician and former New York City health commissioner with an interest in bioterrorism, to run the struggling Food and Drug Administration, according to people familiar with the choice.

Joshua Sharfstein, Baltimore's health commissioner, will serve as Hamburg's chief deputy, according to these sources. Sharfstein, 39, won national attention when he convinced the FDA in 2007 to restrict the use of over-the-counter cough and cold medications for young children. He successfully argued that government needed to limit their use in the face of mounting evidence that they can cause hallucinations, seizures, trouble breathing, heart problems and other complications, including death, and a lack of evidence that they work as intended.

The White House would not confirm the selections. Hamburg could not be reached for comment and Sharfstein declined to talk to a reporter.

Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.

With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply and food.

But morale within the FDA, along with its credibility, has plummeted as the agency has been struggled to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension.

It has been lambasted on Capitol Hill for a series of foodborne illnesses, the most recent of which is an ongoing salmonella outbreak that has sickened 700 people and killed nine others. The agency has been slammed by its own scientists for approving medical devices without proper vetting. And it has been unable to keep up with imported goods pouring into the United States from around the world, including food, drugs and raw materials. That problem has been highlighted by the discovery of contaminated toothpaste from China; tainted pet food that killed hundreds of dogs and cats; and the fouled blood thinner heparin, which took the lives of at least 81 Americans and caused hundreds of serious illnesses.

Health advocates say Hamburg, 53, has the ability to restore competency to the agency.
"It's a brilliant choice," said Harvey V. Fineberg, president of National Academy of Sciences Institute of Medicine. "She is a person who will have the public interest foremost in mind."

She succeeds Andrew C. von Eschenbach, who left in January after being repeatedly accused by consumer groups of making policy that put a premium on politics and the concerns of industry at the expense of science and public health.

"We look forward to working with Dr. Hamburg to ensure that our country continues its leadership in scientific research and innovation across the world, bringing hope to patients and their families battling cancer and other life threatening disease," said Ellen Sigal, chair of Friends of Cancer Research.

Hamburg grew up on the campus of Stanford University, the daughter of two physicians. Her mother, Beatrix, was the first African-American woman to attend Vassar College and to earn a degree from the Yale University School of Medicine. She has credited her Jewish father, David, for teaching her to value education and to fight discrimination.

Hamburg graduated from Radcliffe College and Harvard Medical School, and completed her training at the New York Hospital/Cornell University Medical Center. She did research in neuroscience and neuropharmacology. From 1986 to 1988, she served in the U.S. Office of Disease Prevention and Health Promotion, and from 1989 to 1990 she was assistant director of the National Institute of Allergy and Infectious Diseases at NIH, where her work focused on AIDS research.

In 1990, Hamburg became deputy health commissioner of New York City and was named health commissioner a year later. She created an aggressive tuberculosis control program and the country's first public health bioterrorism defense program.

In 1997, she became assistant secretary for planning and evaluation at the Department of Health and Human Services in the Clinton administration, where she created a bioterrorism program.

Since 2001, she has been vice president for biological programs at the Nuclear Threat Initiative, a think tank focused on the threat to public safety from nuclear, chemical, and biological weapons.

Hamburg is married to Peter Fitzhugh Brown, an artificial intelligence expert who is executive vice president and director of Renaissance Technologies Corp., a privately owned hedge fund. The couple have two children. Hamburg serves on the board of the Sidwell Friends School, which Obama's daughters attend.

By Web Politics Editor  |  March 11, 2009; 6:38 PM ET
Categories:  B_Blog , Cast of Characters  
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Comments

SPECIAL TO PRESIDENT & FLOTUS OBAMA / VP JOE BIDEN / WH STAFF / CABINET MEMBERS / MEMBERS OF CONGRESS / NATIONAL PRESS CORPS

Anyone who has read or heard reports about the ongoing Bush-Cheney spawned or expanded domestic "extrajudicial punishment network" must log on to MINNPOST.COM to see what investigative reporter Seymour Hersh has to say:

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(Then read the comments section of said article.)

For more on "Gestapo USA"...

http://My.NowPublic.com/scrivener

***


SPECIAL TO FDA:

Does the "extrajudicial punishment network" recruit "program" members from the ranks of store clerks, who are ordered to place tainted stock on the shelves when a "target" comes in to buy a favorite brand (info gleaned from surveillance)?

Posted by: scrivener50 | March 12, 2009 6:55 PM | Report abuse

The mission has been to get meds to market. Safety has been left in the dust. The FDA's mission should be to get drugs to the market. As a physician, I was more reluctant to use drugs that were newly released. Newly released drugs should only be available to specialists during the first two years and should not be advertised for at least a year after it is available to all physicians. The frenzy that was associated with the release of Vioxx and Celebrex should be a warning to everyone that we are releasing and using drugs without sufficient investigation. The problem with Vioxx was only partly Merck's behavior. Too many prescriptions will filled for too many inappropriate indications.

Side effects will be discovered after release but the number of people who suffer will be kept to a minimum if only patients with a high risk reward ratio are getting drugs when they are newly released.

Posted by: Gator-ron | March 11, 2009 9:36 PM | Report abuse

I certainly hope they give a new look to the explosion in psych meds foisted on children -- off label no less. Maybe just a smidgen of skepticism before allowing all our children to be given Abilify and Adderall.

Posted by: jdcarmine | March 11, 2009 8:52 PM | Report abuse

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