One of the first things Margaret (Peggy) Hamburg says she will do if confirmed as FDA commissioner is review the agency's recent work on the H1N1 flu situation, according to testimony she is delivering today at her confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.
FDA has worked throughout the crisis to begin developing a vaccine for the virus and accelerate approval of diagnostic tests to detect H1N1. Hamburg led development of a flu pandemic preparedness plan when she served as the assistant secretary for planning and evaluation at HHS during the Clinton administration. Now vice president for biological programs at the Nuclear Threat Initiative, Hamburg said she plans to determine whether FDA could be doing more.
Her next priorities, Hamburg planned to tell senators, will be to improve food safety, increase monitoring of medical products, foster innovation and boost FDA's credibility to eliminate the perception that it is too close to industries it regulates.
"As FDA commissioner I would strive to lead an agency that appropriately balances innovation with regulation," Hamburg pledges in her prepared testimony.
FDA has faced constant congressional disapproval, mounting safety crises in both food and drugs and complaints from employees that former Bush administration appointees too often bowed to industry over safety. Hamburg makes a point to talk about her time as head of a similarly dispirited New York City health department.
"Through our actions, we gave the city an energized department the public could trust again," she wrote.
Hamburg is not expected to face much opposition today.
"I think it will be a smooth hearing overall," said Sen. Richard Burr, R-N.C., a HELP member.
Michael Mahaffey, spokesman for HELP ranking member Michael Enzi, said Enzi will have some questions for the nominee on the timely topic of FDA tobacco regulation, among other things. The HELP Committee is scheduled to mark up HELP Chairman Edward Kennedy's legislation Tuesday that would give FDA the authority to regulate tobacco products.
Health policy experts view Hamburg as a boon to the effort to bestow the responsibility upon FDA since her career focus has been on public health. Many Republicans have argued FDA can barely handle its current workload and should not take on a new responsibility, particularly one of such proportions as tobacco.
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