Obama Taps Ex-NYC Health Commissioner to Lead FDA

President names Margaret Hamburg to oversee food and drug safety.

March 11, 2009, 5:44 PM

March 14, 2009— -- As he announced a new head of the Food and Drug Administration today, President Barack Obama laid out plans for an extensive overhaul of the agency, including a billion-dollar investment to keep tainted peanut butter and tomatoes out of the food supply and to protect patients from contaminated medications like the blood thinner heparin.

"Food safety is something I take seriously, not just as your president, but as a parent," Obama said in his weekly video address. "When I heard peanut products were being contaminated earlier this year, I immediately thought of my 7-year-old daughter, Sasha, who has peanut butter sandwiches for lunch probably three times a week. No parent should have to worry that their child is going to get sick from their lunch, just as no family should have to worry that the medicines they buy will cause them harm."

Obama tapped former New York City health commissioner Margaret Hamburg to be the new FDA commissioner. The Senate must confirm the appointment.

The president's plan would boost the number of food inspectors and modernize labs to better keep tabs on the nation's food supply. It would also take steps to ensure sick cows don't enter the food supply.

Of the past way of doing things, Obama said, "That is a hazard to public health. It is unacceptable. And it will change under the leadership of Dr. Margaret Hamburg."

Obama said vulnerabilities in the food safety system stemmed in part from outdated guidelines.

"Part of the reason is that many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt," he said.

Baltimore health commissioner Joshua Sharfstein was named principal deputy commissioner of the FDA, the No. 2 slot.

By putting two public health officials in charge of the organization, the president is seeking to revitalize the FDA as a public health agency, health experts said.

Commenting on the Hamburg and Sharfstein picks, Sid Wolfe, director of Public Citizen's health research group, told ABC News this week that he couldn't think of two people with more extensive on-the-ground experience in public health.

Challenges That Await the FDA

If confirmed by the Senate, Hamburg will take the reins of an agency dogged by controversy.

"There are few jobs in the federal government that are as tough or important as FDA commissioner," Consumers Union director of food policy initiatives Jean Halloran said in a statement this week.

"Dr. Hamburg would first have to help the FDA get the budget and authority it needs so it can visit food processors every year, instead of once every 10 years, and can inspect their records and impose meaningful penalties on violators," Halloran said.

Widely reported to have been the frontrunner for the post, Hamburg is an expert in bioterrorism and served as a health policy adviser to President Bill Clinton. Before serving as New York City's health commissioner from 1991 to 1997, she specialized in infectious disease as an assistant director at the National Institutes of Health's National Institute of Allergy and Infectious Diseases.

"She has been forward-thinking in her approach both to medical and food security issues -- a quality that should enable her to return the FDA to its role as a trusted, effective regulatory agency," said Michael Jacobson, executive director for Center for Science in the Public Interest in a Saturday statement.

Sharfstein, a pediatrician, helped lead the charge to ban over-the-counter cold medication for young children.

He also has direct ties to the White House and Capitol Hill. He worked as an investigator for Rep. Henry Waxman, D-Calif., now chairman of the powerful House Energy and Commerce Committee, before becoming Baltimore's health chief. Under Waxman, Sharfstein investigated tobacco companies, and in Baltimore he has fought to reduce smoking, experience that could be vital with Congress considering giving the FDA authority to regulate cigarettes as drug-delivery devices.

Sharfstein had also been floated as a possible commissioner of the agency but vigorous opposition to his nomination was possible due to his reputation as a crusader against drug companies. The deputy position does not require confirmation.

Obama Announces Working Group to Update Food Safety Laws

Ensuring the safety of the country's food and drug supply is a daunting task. Many observers have said the FDA does not have enough people or money to do the job well.

"The system is not set up to catch bad actors, at least not until the problem has already erupted, really on a nationwide level," Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, told ABC News in January during a peanut recall.

"I believe it is broken, I believe it needs to be fixed," Tom Nassif, president and CEO of Western Growers, told ABC News in July 2008 when the FDA was trying to determine what was contaminating tomatoes. "I know that FDA and CDC must be tremendously frustrated by their inability to trace back the source."

David Acheson, FDA's assistant commissioner for food safety, explained the enormity of the job in January during the peanut recall.

"Clearly in the context of a global food supply, the more integrated the system is, the more standardized it is, the better," Acheson said. "And there's definitely significant moves in that direction. Not just from the FDA but from the states as well. So we're moving in that direction, but FDA doesn't have a mandate to require every state to do exactly what FDA tells it to do."

Consumers and lawmakers alike have also worried the FDA is not doing enough to inspect foreign food and drug plants. In addition to domestic health scares, the FDA has recently dealt with blocking the import of Chinese milk products and zeroing in on where along its international supply chain the blood thinner heparin became tainted.

The agency has also confronted controversy about the safety of diabetes drug Avandia and recalls of the painkiller Vioxx -- flaps that left some wondering whether the FDA is effectively regulating drugmakers.

"We want to work with Dr. Hamburg to reform the way FDA approves medicines," said Consumers Union health analyst Bill Vaughan in a March 11 statement. "Between contaminated imports and the use of dishonest research results, the American medicine cabinet has become a little shop of horrors. In recent years, the agency has been too slow to protect consumers and too willing to give industries a pass on safety."

Lawmakers have repeatedly voiced their frustrations with the FDA.

"Either you don't have the resources, or you are incompetent to do the job you're supposed to do," Rep. John Dingell said to FDA food safety director Stephen Sundlof at a February hearing on the peanut recall. "Which conclusion am I to arrive at?"

Some in Congress have even said the challenges are so enormous that food and drug oversight needs to be completely reorganized. They support creating a separate food safety agency, in part because responsibilities are currently split between the Department of Agriculture, which monitors meat, poultry and eggs, and the FDA, which monitors all other food.

At a hearing this week on Capitol Hill, however, Waxman said that isn't going to happen just yet, citing a need to first clean up the current structure before taking on a more extensive overhaul.

Today Obama called for the creation of a Food Safety Working Group, to be jointly led HHS and agriculture secretaries. He said he expects the group to report back on upgrading food safety laws as soon as possible.

"We need to be reactive when problems occur," Acheson said in January. "We need to do that faster. We need to recognize the problems earlier. But more importantly we need to establish preventitive controls."

"No one can inspect and test everything," Acheson said. "It's just not humanly possible. So we've gotta be smart about what we test, where test it. What we look for."

ABC News' Brian Hartman and Lisa Stark contributed to this report.

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