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Top Brass on FDA as “Public Health Agency”

PeanutsShortly after being sworn in as the Commissioner of the Federal Drug Administration last Friday, Margaret A. Hamburg and her principal deputy commissioner, Joshua Sharfstein, described their plans to run the FDA as a public health agency in New England Journal of Medicine. The agency, charged with regulating much of the U.S. food supply, is known for being unnecessarily complex, fractured, and underfunded.

However, a budget increase of 5.7 percent, to $2.4 billion, along with Commissioner Hamburg and deputy Sharfstein’s plan for improving food safety through partnerships with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, the National Institutes of Health, the pharmaceutical and biotechnology industries, individual states, and various academics should bring hope for the safety of the U.S. food supply yet. The FDA and USDA will continue to follow the salmonella outbreak from contaminated peanut butter earlier this year that sickened hundreds of Americans and is responsible for several deaths.

Referring to the outbreak, Hamburg and Sharfstein write: “It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls.” With this recognition, Hamburg and Sharfstein intend to work with Congress to update food safety laws that will hopefully prevent future “Peanutgates.”

In the spirit of public health, Hamburg and Sharfstein acknowledge “the urgent need to develop and produce a vaccine against H1N1 influenza virus,” which is currently being studied at the FDA. “The agency’s success will be determined by the nation’s access to a safe and effective vaccine,” said Hamburg and Sharfstein.

Image: Couse-Baker

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