FDA's $25 Million Pitch for Improving Drug Regulation

The U.S. Food and Drug Administration (FDA) is pressing for a big funding boost for "regulatory science"—research that can help it evaluate new treatments better and faster. Yesterday, FDA chief Margaret Hamburg laid out her case for regulatory research at the National Press Club while FDA released a report on the subject. The agency wants to devote $25 million next year to regulatory science, a small slice of the $4 billion President Barack Obama's Administration has requested for the agency in 2011. Congress has not yet approved that request.

FDA is trying to move forward nevertheless, in part by linking up with more flush agencies. Last week, in conjunction with the National Institutes of Health (NIH), it announced four sizable grants, totaling $9.4 million, in regulatory science. (FDA contributed just under $1 million and NIH gave the rest.) They include support for a heart-lung system that can test potential drugs and an effort to dramatically streamline clinical trials.

"Our current approach [to trials] is horribly inefficient, and we need to do something better," says Roger Lewis, an emergency medicine physician at Harbor-University of California, Los Angeles, Medical Center. Lewis helps advise a company called Berry Consultants founded by Donald Berry, a biostatistician at M.D. Anderson Cancer Center in Houston, Texas. He and Berry, along with emergency medicine physician William Barsan at the University of Michigan, will be studying whether "adaptive" trial designs that incorporate new information in midcourse can answer medical questions. They also want to learn what concerns researchers might have about this approach. Adaptive designs examine how patients are responding to treatment as a trial runs and adjust how people are assigned to a new therapy accordingly. The three, led by Barsan, will be testing this approach in neurological studies such as stroke and cardiac arrest. The goal, says Barsan, is to use an existing neurological trials network as a laboratory to examine this strategy for improving trials.

FDA also wants to disperse the $25 million among a range of other projects: Linking specific ingredients in cigarettes to smoking-associated diseases; developing new chemical tests to assess the safety of fish caught for food in the Gulf of Mexico, following the April oil spill there; and developing better methods to characterize stem cells that might be given to patients.

"Billions of dollars have been invested in biomedical research," and those have led to major advances, Hamburg said yesterday in her talk. "But right now we lack the ability to effectively translate these developments into vital products for those who need them."