At a December 11 conference that focused largely on the current and future policies of the Food and Drug Administration, AEI resident fellow Scott Gottlieb argued the need for change in the agency's drug-approval guidelines: "The question that's going to come up over the next several years as we look to drive some change within the FDA is how much evidence is required and how many people we're going to let die while we sit and gather that evidence."

Gottlieb critiqued the FDA's current regulatory process as taking too long, discouraging drug development because of high trial costs, and relying on statistics that end up keeping drugs from the market.

Advocating drug trials that allow patients greater and quicker access to the drugs, Gottlieb suggested that regulators use "dirty data" in which doctors give drugs to patients in "real world situations." While providing drugs in this manner is not as controlled as a clinical trial, more data is generally available, and it is more representative of the way doctors would prescribe medicine. Gottlieb said: "In the final analysis it comes down to different schools of statistics in the FDA and whether or not we are going to continue to adopt this path of these very rigorous trials or adopt something that opens up the process more."

The conference's luncheon speaker, Mark McClellan, a former AEI scholar who was recently confirmed as commissioner of the FDA, discussed his vision for the agency. "There has never been a time in the history of the FDA when we have had either more challenges or more opportunities for meeting those challenges."

McClellan rejected a narrow vision of the FDA's mission, saying it must recognize "the important benefits that new products can bring to the public" and have "a bottom-line focus on improving overall health outcomes in this country."

Within this broad mission, McClellan identified three specific priorities. First, a focus on national defense. He said, the FDA is responsible not only for the safety of the food supply, but also must play an important role in the development of measures to protect against terrorist attacks involving chemical, biological, and radiological weapons. The "FDA probably has never thought more critically or carefully about the need for [the] appropriate use of products in wartime situations both at home and in use by the military," McClellan said. "So this is a tremendous new set of responsibilities that we must rise to meet."

McClellan identified the second priority as reducing medical errors and avoidable complications. "By finding new ways, using new information technology, such as automatic electronic data reporting, we think we can find ways to understand better why complications and adverse events involving FDA[-approved] products are occurring." The FDA can "reduce the occurrence of those problems through better labeling [and] better education of providers and the public."

His third priority was to help the American public make better choices about diet, exercise, and lifestyles. "This is an area where [the] FDA has a tremendous responsibility since we regulate all of the health claims made by potentially any product that makes a health claim in our economy." McClellan said. As the FDA asks the American people to do more to recognize that they have "the greatest opportunities to improve their own health, it would help us achieve our disease prevention goals" if we provide good information to guide the public's decisions about eating right and doing other things to improve their health.

AEI resident scholar John E. Calfee responded optimistically to McClellan's comments, remarking that the FDA "has a new commissioner who's taking an extraordinarily broad and open view regarding what the FDA should and could be doing. I think that's a very fortunate circumstance generally."