A long ‘to-do’ list for FDA Chief Hamburg

Jun 18 2009

The Washington Post details Food and Drug Administration Commissioner Margaret Hamburg’s to-do list, noting that during her brief tenure the agency has announced nearly-daily warnings about various consumer products and created an internal task force to recommend ways to release more information about FDA decisions and policies.

Hamburg's list "goes beyond reorienting and restoring public confidence in the FDA. Last week, Congress passed historic legislation that gives significant new authority and responsibility to the FDA to regulate tobacco for the first time. That means Hamburg must create a new center within her agency to handle oversight of the manufacturing, marketing and sale of cigarettes, cigars and other tobacco products. And today a House committee takes up legislation that would give FDA broad new powers to regulate food safety -- a bill that House leaders are determined to pass this year. The bill would place greater responsibility on the food industry to prevent food-borne illnesses and would require the FDA to significantly expand its inspection and oversight of the industry" (Layton, 6/17).

USA Today lists some of the top items on Hamburg’s agenda:

• Tobacco. The agency will be setting up a new center on its main campus to oversee tobacco products, Hamburg says, just as it has centers that oversee drugs and other products. Many people have expressed interest in working for the new FDA tobacco center, she says, because they view its creation "as a historic moment in public health."
• Drugs. While "FDA does play a critical role in fostering innovation," Hamburg says, the agency also has "almost a sacred responsibility to assure safety in the use of these products." The FDA plans to require additional safety studies of drugs once they are on the market, she says, and it will encourage health care professionals and consumers to be more conscientious about reporting adverse effects.
• Direct-to-consumer advertising. "There certainly have been concerns about the quality and authenticity of some of the messages," Hamburg says. "We have a dedicated staff working on the issue" (6/16, Rubin).