FDA, MIT TO COLLABORATE ON DRUG SAFETY
The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases as part of a broad agency initiative to improve its postapproval monitoring of drugs, a high-ranking FDA official said.
The FDA and MIT's Center for Biomedical Innovation (CBI) will work to supplement the agency's current safety data with automated healthcare databases that will allow the FDA to undertake real-time drug safety monitoring.
Doing so will help address shortfalls in the current system, Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs, told CBI members during an Aug. 17 meeting. "We need to improve the information we rely upon, and our tools and resources for gathering that information in a timely and reliable way," he added.
The FDA has been under pressure to make changes to its drug review program, facing growing criticism for its handling of Vioxx and other drugs, with critics arguing that the FDA review process is too slow and incomplete to catch potential problems.
MIT will use advanced computerized methods to automate the process of recognizing unusual patterns of infectious disease. Doing so would allow the agency to more quickly identify problems with drugs used to treat these diseases, allowing for an accelerated response. These tools will be similar to those public health departments and the Centers for Disease Control and Prevention use to fight bioterrorism and pandemic influenza.
But these changes require more than planning. "All of this is going to require significant new investments in time and resources aimed at improving FDA's IT backbone, which has grown outdated over the years," Gottlieb said. "It will also require continued support by Congress."
The proposal got the support of several activists. "This has potential," William Vaughan, senior policy analyst for Consumers Union, said. The agency will need more money to pay for these projects, perhaps through the next round of Prescription Drug User Fee Act (PDUFA) negotiations. PDUFA expires Oct. 1, 2007.
The move is beneficial, Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, said. These databases are helpful because they "allow more early warning signs to be seen -- and seen earlier."
However, Sidney Wolfe, director of Public Citizen's Health Research Group, rejects the proposal. The agency has long developed detailed databases to track side effects, but rarely acts on that information, he said. "Analysis without action is really a fraud." Also, this move seems to override the Office of Drug Safety, which usually takes on such responsibilities. Contracting out this work is "an insult" to that office, he added.