A Bigger, Bolder Agency

When a salmonella contamination hit pistachio nuts a few months ago, FDA moved quickly to recall products and shut down processors. These days, officials are sending out more warning letters, as well as taking bolder enforcement actions and a more proactive approach to health emergencies such as swine flu. Make no mistake: There's a new sheriff in town, and principal deputy commissioner Joshua Sharfstein set the tone early with several high-visibility actions pending confirmation of Margaret (Peggy) Hamburg for the top spot. Their task is now to restore the agency's image, both with the public and at its new White Oak, MD, campus.

Since coming to FDA at the end of March, Sharfstein has promised aggressive action to ensure food and drug safety; he responded to criticism of FDA's process for regulating medical devices by supporting a review of research requirements for device classes. During the same period, FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) sent letters admonishing 14 drug companies about their inappropriate use of sponsored links on Internet search engines such as Google. The criticism comes from presenting information on drug benefits on an initial posting while requiring at least one click to disclose risks. Marketers contended that FDA was ignoring the communications capabilities of Internet technology, but consumer advocates cheered the policy as necessary for balancing information on drug risks and benefits.