FDA Commissioner Nominee Hamburg Sails Through Confirmation Hearing
| Date Posted: May 8, 2009 |
If Margaret Hamburg’s Senate confirmation hearing is any indication, she should receive easy approval as the next commissioner of the FDA.
President Obama’s nominee for the agency’s top post had little trouble with her hour-and-a-half long confirmation hearing May 7, making broad pledges to reform the agency while rehabilitating its tarnished public image.
“The American people place a huge amount of trust in the FDA,” said the 53-year-old former assistant secretary for planning at Health and Human Services and onetime Commissioner of Health for New York City. “It is critical that we take steps to boost their confidence, particularly when it comes to the safety of drugs and food.”
Product safety — particularly food safety concerns — dominated the Senate Committee on Health, Education, Labor and Pensions hearing.
“I will focus on improving food safety,” Hamburg stated. “Domestically, this means taking advantage of the growing consensus among experts and industry that now is the time to shift to a food safety system that puts prevention first. Important steps must be taken to protect the nation’s food supply — from farm to fork — to strengthen our food safety system to prevent outbreaks from happening in the first place. Globally, this means increasing FDA’s attention and energies to import safety.”
Sen. Barbara Mikulski, D-Md., devoted part of her question-and-answer session to accusations made by a group of employees at the Center for Devices and Radiological Health (CDRH). The employees alleged in January that managers at the Center had corrupted the scientific review process to speed device clearances. She asked Hamburg whether whistleblowers would be taken seriously if she became FDA Commissioner.
Hamburg replied that whistleblowers serve a very important role in government, in raising critical issues and concerns and making sure that they’re addressed, adding that she intends to “create a culture [at the FDA] that would enable all voices to be heard.”
Mikulski also gently prodded Hamburg on a recent study out of the Dartmouth Institute that suggested consumers could get more out of a layman-oriented information box in direct-to-consumer advertisements than they could out of the required brief statement.
Hamburg confessed that she was not familiar with the study — which appeared February in the Annals of Internal Medicine — but said she would “love to learn more about it” while acknowledging that “safety and efficacy are at the core” of the agency’s mission.
Sen. Christopher Dodd, D-Conn., brought up the subject of pediatric medical devices, asking Hamburg where she stood on the topic. She explained that pediatric devices should “address the needs of children in different stages of development” rather than treat them “like little adults.”
During an exchange with Sen. Bernie Sanders — an independent from Vermont — on the Saturday morning glut of commercials for sugary breakfast cereals, Hamburg noted the importance of appropriate labeling when it comes to foods. “I think it is very important that the government lead the way with communicating critical information, in terms of establishing guidelines and standards, and in many cases, mandating certain kinds of activities, helping consumers to better understand the substantial risks they’re being exposed to is important, and labeling of [food] products is important,” she said.
Sanders gently pressed her on the issue, asking if she would consider regulating such advertisements. “I think that’s a bit beyond the scope of the FDA’s commissioner,” she responded.
Liability issues also made their way into the conversation, as part of a laundry list of concerns facing the agency cited by Sen. Robert Casey Jr., D-Pa.
Sen. Orrin Hatch, R-Utah, broached the topic of regulating dietary supplements and over-the-counter products, eliciting the following response from Hamburg: “This is really a complex issue and one that I have not been deeply involved in … but clearly FDA has an important role in ensuring to the American people that these products that they take for their health and to supplement their health will be what they claim to be and be safe.”
The only time Hamburg was not all smiles was during the exchange with Hatch, when he raised the question of authority at the agency. He referenced speculative reports that her deputy commissioner — current Acting FDA Commissioner Joshua Sharfstein — would act more as a co-commissioner on issues such as drugs.
After hearing this, her smile faded and she stated forcefully “well, I will be the commissioner.”
For continuing coverage of FDA issues see Thompson Publishing Group’s library of FDA-related publications.
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