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VOL. 39 | NO. 5 | Friday, January 30, 2015

Outgoing FDA chief saw changes to food safety, tobacco rules

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WASHINGTON (AP) — From food safety to tobacco regulation and politically charged drug approvals, Margaret Hamburg reset the course of the embattled Food and Drug Administration.

After nearly six years as FDA commissioner, Hamburg announced her resignation Thursday in an email to staff. She said the agency's chief scientist, Stephen Ostroff, will serve as acting head of FDA.

She is among the longest-serving commissioners to head the agency and helped oversee the creation of a new food safety system, innovations in how drugs are reviewed and new tobacco regulations.

President Barack Obama named Hamburg to the post in 2009 following a series of high-profile safety problems at the agency ranging from contaminated blood thinners to salmonella-tainted peanut butter that required one of the largest food recalls in U.S. history.

"What she offered was stability, accomplishment, effectiveness and restoring some of that prestige that it had lost," said Steven Grossman, a former FDA official who now heads Alliance for a Stronger FDA, which advocates for increased FDA funding. "I think that she leaves the place in so much better shape in terms of almost any dimension you can think of."

Still, agency critics sometimes questioned Hamburg's judgment. Politicians, law enforcement officials and anti- addiction groups have all criticized the agency for not doing more to combat the epidemic of prescription painkiller abuse, linked to over 17,000 U.S. deaths annually. Hamburg defended the agency's ongoing approval of powerful new opioid drugs, saying they are an important option for patients with chronic pain.

Public Citizen, a frequent critic of drug companies, said in a statement that the FDA "has grown even more cozy with the industries that it regulates" under Hamburg's tenure.

An agency that regulates one-fourth of the U.S. economy, the FDA's chief is subject to scrutiny from an array of outside forces, including consumer and health advocates, multinational corporations, politicians and medical professionals. Hamburg stayed on the job longer than her three predecessors combined.

Under Hamburg's tenure, the FDA was more active on food policy than it had been since nutrition labeling rules were first written in the early 1990s. The agency has worked to put new food safety rules in place, phased out artery-clogging trans fats from the food supply, proposed updates to nutrition facts on the backs of food packaging and required restaurants and retailers to label calories on menus.

The agency also won authority to regulate the tobacco industry for the first time, focusing on how cigarettes are marketed. The agency has banned flavored cigarettes except for menthol; removed labels such as "light," ''mild" and "low-tar" from cigarette packs; and increased the size of warning labels on smokeless tobacco.

In her goodbye note to staffers, Hamburg emphasized the importance of science in these decisions and other reforms aimed at speeding up drug reviews and overseeing specialty pharmacies.

"At the heart of all of these accomplishments is a strong commitment to science as the foundation of our regulatory decision-making and of our integrity as an agency," Hamburg said.

She took control of the agency at a time when its reputation had been battered by accusations that officials were allowing politics to influence medical decisions. A federal judge ruled that in 2006 the agency deliberately delayed making a decision on the Plan B morning-after pill at the behest of the Bush administration.

The same contraceptive became a political liability under Hamburg when the FDA attempted to approve its sale over-the-counter for teenagers. But at the eleventh hour the head of the department of Health and Human Services intervened and overruled FDA, deciding that young girls shouldn't be able to buy the pill on their own. Hamburg stood by her agency's decision and the drug was approved for non-prescription use in 2013.

In another high-stakes drug controversy, Hamburg personally made the decision to revoke the blockbuster drug Avastin's approval to treat advanced breast cancer, based on evidence that it did not actually help patients.

Hamburg, 59, is a doctor and former New York City health commissioner. The daughter of two physicians, she is known as a bioterrorism expert who has also studied neuroscience and AIDS research.

News of Hamburg's departure comes just a week after the agency announced that Robert Califf, a prominent cardiologist from Duke University, would take on the agency's No. 2 leadership position. Califf was considered for Hamburg's job and many FDA observers say he could eventually replace her.

Hamburg's successor will inherit some of her unfinished priorities, like the update on nutrition facts labels proposed last year and voluntary standards for sodium levels in packaged foods that Hamburg promised in 2010 but never delivered. The food safety rules have yet to be finalized.

Hamburg has at times had to push the White House to move on her priorities as the industries have pushed back.

David Kessler, FDA commissioner from 1990 to 1997, says Hamburg "deserves enormous credit for pushing the issues as far as she did."

Still, he said, her legacy isn't complete.

"It could be a very strong legacy for this administration, but they need to complete this work," Kessler said.

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