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NY Times:

President Obama intends to nominate Dr. Margaret A. Hamburg, a former New York City health commissioner, to lead the Food and Drug Administration, sidestepping a battle between drug safety advocates and the drug industry, people briefed on the decision said.

Before getting to Dr. Hamburg's bio (which is very strong), the Times adds some very important context about the FDA:

The food and drug agency regulates more than $1 trillion worth of consumer goods, which amounts to about 25 cents of every consumer dollar spent in this country. Besides policing billions in food, drug, cosmetic and vitamin sales, it is responsible for monitoring a third of all imported goods, items as varied as eggplants, eyeliners, microwave ovens, monoclonal antibodies and cellphones.

The F.D.A. is arguably the most important public health agency in the country, but its budget has lagged far behind those of agencies like the Centers for Disease Control and Prevention. A growing list of scandals has led a bipartisan chorus on Capitol Hill to demand major changes and larger budgets, with some legislators advocating that the F.D.A. be split in two.

Wikipedia adds some more perspective on the FDA's enormous scope:

The FDA regulates more than $1 trillion worth of consumer goods, about 25 percent of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.

It does all that with a 2 billion dollar budget, and there are plenty of critics who think that's not nearly enough.

There are some details in the Times story of note, such as Hamburg being something of a compromise candidate, but the key points are two background features:  she has a strong public health background, something that will be enormously important in reviewing food safety, and she also has a very strong administrative background (running a NYC agency like the Department of Health is good training ground for the battles she will face running an underfunded and neglected agency that was a pressure point (see Plan B) in the Bush war on science.)

What did she do as NYC Health Commissioner?

Margaret Hamburg, one of the youngest people ever elected to the Institute of Medicine (IoM, an affiliate of the National Academy of Sciences), is a highly regarded expert in community health and bio-defense, including preparedness for nuclear, biological, and chemical threats. As health commissioner for New York City from 1991 to 1997, she developed innovative programs for controlling the spread of tuberculosis and AIDS.

including the now-accepted standard of directly observed therapy of TB drugs to insure compliance. Did it work?

While commissioner Dr. Hamburg's innovative treatment plan for tuberculosis (TB) became a model for health departments around the world. In the 1990s, TB was the leading infectious killer of youths and adults and had become resistant to standard drugs. To be effective, new drugs required patients to take pills every day for up to two years, but failure to complete the full course of treatment allowed the bacteria to mutate into drug-resistant strains. Hamburg sent healthcare workers to patients' homes to help manage their drug regimen, and between 1992 and 1997, the TB rate for New York City fell by 46 percent, and by 86 percent for the most resistant strains.

As the Times notes in its excellent overview article, Hamburg seems as qualified to be at CDC as FDA, but this is a huge bonus for an agency that needs to be better integrated with other public health agencies under the auspices of Kathleen Sebelius and HHS (btw, she's also been an assistant secretary there.)

In fact, her choice will spark speculation (as was mentioned in the Times) that the FDA might split into separate food and drug agencies.

An example of the reaction comes from Jeffrey Levi (who was interviewed here on Daily Kos a few weeks ago):

Jeffrey Levi, executive director of Trust for America’s Health, a nonprofit public health organization, said Dr. Hamburg had revived a demoralized and cash-starved agency in New York and could do the same at the F.D.A., which faces similar problems.

"Right now," Mr. Levi said, "the F.D.A. needs a strong leader with a clear sense of mission who can fight for the resources that the agency needs and do it in a bipartisan manner."

Mark Senak, who blogs at Eye on FDA, refers to Dr. Joshua Sharfstein, current head of the Baltimore Department of Public Health, and up for Deputy Commissioner, says:

These are welcome appointments and frankly, are the kind of medicine needed.

...There is every indication by her past, that Margaret Hamburg is up to the task.  Her years as Director of the New York City Department of Public Health occurred at the height of the AIDS epidemic before there were any effective treatments for the disease.  The entire scope of that job is not dissimilar in nature to the breadth of the scope she faces now.  It was a very tough, very political atmosphere.  She has the backbone for this job and it will remain to be seen whether she has the vision and the depth that will be needed to match the breadth of what needs to be accomplished.  

On the face of it, this seems to be a strong un-traditional choice for an agency that is in desperate need of revitalization, and needs to see itself (as does the public) as an integrated part of the public health system. Hamburg and Scharfstein will bring a different perspective to the FDA, and hopefully the budget to get its job done. With issues like the nation's food safety, and whether tobacco is a drug to be regulated, their plate is already full. And keep an ear open for that "break up the FDA" conversation, as the new team takes stock of the task ahead.

The alternative to competent leadership at the FDA is illustrated by this Onion piece:

FDA Approves Salmonella

Calling it "perfectly safe for the most part," and "not nearly as destructive or fatal as previously thought," the Food and Drug Administration approved the enterobacteria salmonella for human consumption this week.

The federal agency, which has struggled in recent years to contain the food-borne pathogen, and repeatedly failed to prevent tainted products from reaching store shelves, announced Monday that salmonella was now completely okay for all Americans to enjoy.

...Following the announcement, the FDA released a 20-page report, which included evidence that salmonella is barely more dangerous than other live-culture products such as yogurt, and results from a clinical trial which found that participants who ingested salmonella were totally fine for up to three minutes.

The line between funny and scary is pretty thin these days. Watch this from the Onion:

and ask yourself how it was that the FDA got to be the butt of all these jokes.

Originally posted to Daily Kos on Thu Mar 12, 2009 at 05:50 PM PDT.

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