A New Look for the Old FDA

The Food and Drug Administration that we know, love, and on occasion love to hate, may soon be a memory. The winds of change are blowing toward Rockville, and the agency may never be the same.

The signs are all there. First, Margaret Hamburg, PhD, was appointed FDA Commissioner. The savvy, former New York City Health Commissioner knows politics as well as her way around a budget. During her tenure in New York, she managed to quell two major health crises, one by persuading a financially strapped city council to spend money on health services such as public workers hired to visit neighborhoods and watch patients take their medicines. Her modus operandi is a combination of public calm and reliance on science, two essentials for an agency in dire need of an unflappable hand at the wheel.

The nomination of Kansas governor Kathleen Sebelius as Health and Human Services secretary was the second indicator that FDA is headed for a serious shake-up. Governor Sebelius garnered the national spotlight when she conquered a $1.1 billion budget deficit in her first year in office without raising taxes. During her confirmation hearing, she committed to making FDA a "world-class regulatory agency," and cited the need to "involve industry in making sure that we look at products as they move through the food chain and that there is some collaborative operation to make sure that those supply chains are also very involved in keeping our people safe."

Some would argue that the supply chain is already involved in keeping people safe, but that's another editorial. The point is, as HHS secretary, she will be under substantial pressure to improve the image, if not the safety, of the nation's food supply.

To be frank, the public image of food safety could use a little burnishing. In an epic case of bad timing, the day before Sebelius's confirmation hearings, Setton Pistachio (Terra Bella, CA) announced a voluntary recall of approximately 1 million lb of pistachios because of possible salmonella contamination. The pistachios were sold to other companies as ingredients, triggering a chain reaction of recalls from Kraft, Frito-Lay, Whole Foods, Publix, and many other companies.

One solution expressed during the hearings and heard around Washington was to sunder foods from drugs. Governor Sebelius said that it was too soon to talk about splitting FDA's food and drug safety responsibilities into two agencies as some critics have suggested, but the idea was not dismissed so easily. One day after the pistachio incident, the White House announced the creation of a food safety panel chaired by Sebelius and newly minted agriculture secretary Tom Vilsack. The USDA could assume some of FDA's prevention duties, said Vilsack, giving FDA more time for containment and damage control. Other officials pointed to FDA's slim budget and broad mandate as reasons to try something new.

If a reconfigured FDA seems nothing more than Washington hot air, consider what would happen if Congress passed H.R. 1256, which the House approved by a 2:1 margin early in April. The Family Smoking and Tobacco Control Act gives FDA power to regulate tobacco. The bill has limits-FDA can't ban tobacco products outright or set nicotine levels at zero-but allows the agency to regulate how tobacco products are advertised, flavored, and labeled, and requires premarket approval for all new products. If the bill survives the Senate, and if the president signs it into law, FDA will have two years to promulgate new tobacco regulations, a daunting task for its overworked staff.

Meanwhile, one more recall could mean the difference between FDA as it is, and an FDA divided into more manageable pieces. In the event of another incident, HHS Secretary Sebelius and FDA Commissioner Hamburg surely will want to shore up the nation's food safety firewalls. As nominee Sebelius said, inaction is not an option.

James Wagner
Group Publisher
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e-mail: jwagner@nutritionaloutlook.com