FDA’s First Year Under Obama: Miles Ahead, Yet Miles to Go

This post is the fourth in a series on the new CPR report Obama’s Regulators: A First-Year Report Card.

During the Bush Administration, the Food and Drug Administration (FDA) simply fell further and further behind in terms of achieving its regulatory mission of protecting people from unsafe drugs, medical devices and food. A series of high profile mistakes made it clear that the American people could no longer lightly assume that the food they were eating and the drugs they were taking were safe. The challenge for the Obama Administration was to reenergize this demoralized agency, so that it could begin the difficult task of making up lost ground. FDA was able to make up a lot of this lost ground; that it still has so much further to go in order to make our food and drugs adequately safe illustrates how bad things were when President Obama assumed office.

Coming into President Obama’s first year in office, FDA faced a number of obstacles to achieving adequate food safety. Like other protector agencies, FDA has been chronically resource-starved, which hampered its ability monitor the food supply. As a result, the agency had little ability to prevent food-borne illness outbreaks, much less respond to them quickly when they did occur. FDA also suffers from a lack of adequate legal authority to ensure food safety. The task of ensuring food safety is divided among various federal agencies, and the resulting hodgepodge leads to unnecessary duplication and gaps in protection. Moreover, existing law does not authorize FDA to order recalls of tainted food—instead, the agency can only ask companies to recall their products. Finally, to make matters worse, FDA’s regulatory mission with respect to food safety has gotten a lot larger and a lot more complicated. The U.S. population has increased significantly, and the U.S. food supply is becoming more and more globalized, with food products now coming from countries that have little or no regulatory oversight over the goods they produce.

Despite these obstacles, FDA was able to make some progress on food safety—particularly with regard to the challenge of imported foods. The agency launched some promising initiatives on the inspection and enforcement front that would enable it to detect and potentially prevent food-borne illness outbreaks. For example, FDA began stationing mobile food safety laboratories at major ports of entry for imported foods. The labs test for E. coli and salmonella, the two contaminants responsible for most of the outbreaks. These labs enable FDA to test more foods, and to do so more quickly, thereby reducing the chances that such outbreaks will occur in the first place. The agency also initiated a pilot project in which it will work with state public health officials to create “rapid response” teams for investigating food-borne illness outbreaks more quickly.

On the regulatory front, though, FDA’s work on food safety was more mixed. FDA did make some progress in this area, such as launching the Reportable Food Registry, an electronic database that is intended to help the agency to more quickly identify and respond to food-borne illness outbreaks. While sound in theory, however, the Registry is not guaranteed to succeed in practice. The potential problem with the Registry is that its success ultimately depends on FDA’s ability to get the food industry to report information about food-borne illness outbreaks. To implement the program, the agency has issued regulations requiring the food industry to self-report such information. FDA must make it clear from the get-go that it intends to strictly enforce these regulations by holding the food industry accountable for failing to make timely and accurate reports about outbreaks. Otherwise, the Registry will end up being just another empty program. Time will tell if FDA can make this program a success.

As FDA’s experience with food safety this past year illustrates, the agency has been making progress—the food supply is undoubtedly safer now than it would have been if the Bush Administration had somehow extended into a ninth year. Unfortunately, and as President Obama himself recognizes, doing better than the Bush Administration is not enough. Rather, federal law mandates that FDA make the food supply safe, and that mandate is not currently being met. Obviously, it would be unfair to expect the Obama Administration to reverse years of neglect at FDA and turn the agency into the full-functioning and effective protector agency in just one year. As the Administration will quickly discover, however, four (or even eight) years can go by in a blink of an eye. If it intends to fulfill its promise of protecting the public against unsafe food, drugs, and medical devices, the Obama Administration cannot afford to delay reenergizing the FDA, by undertaking such measures as increasing its budget, limiting interference from the White House, and working with Congress to enhance the agency’s legal authority.