FDA Pushes MIT Database Partnership To Advance Healthcare IT

The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases to improve the agency’s postapproval drug and medical device monitoring, a high-ranking FDA official said Aug 17.

The new project is part of a broader agency effort to spur healthcare IT adoption, said Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs. “IT has been slowly and sparingly adapted to healthcare,” he told MIT’s Center for Biomedical Innovation (CBI) members during a speech in Boston.

“Healthcare has not realized the same benefits from these new tools” as other industry sectors have, Gottlieb said. “To make it come to pass as soon as possible, we need to overcome some important obstacles and … work on new approaches.”

The FDA and the CBI will work to supplement the agency’s current drug and device safety data with automated healthcare databases.

Doing so will help address shortfalls in the current system, Gottlieb said. “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.

MIT will use advanced computerized methods to automate the process of recognizing unusual patterns of infectious disease. 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.

“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to require significant new investments in time and resources aimed at improving FDA’s IT backbone, which has grown outdated over the years,” Gottlieb said.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 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.”

Consumer Group Wary

But Sidney Wolfe, director of Public Citizen’s Health Research Group, rejects the proposal, saying the FDA has long developed detailed databases to track side effects and already has contracts in place allowing the agency to use external databases. “To some extent, [the MIT proposal] would be redundant,” he said. Further, the real problem is that the agency rarely acts on the information it already has, Wolfe said. “Analysis without action is really a fraud.”

But Gottlieb said the new databases are needed because side effects are becoming harder to detect, necessitating more comprehensive and current databases. Such continuous monitoring can yield unanticipated benefits as well. “It is a two-way street,” Gottlieb argued, maintaining that there are dozens of instances over the last decade where a drug’s initial indication was “dwarfed” by subsequent discoveries.

Better Analysis Needed

The agency also must improve its analysis of this edata, determining how to draw conclusions that doctors and patients can apply in their risk-benefit decisions, he said. “Right now, one of the shortcomings of our approach is that we are not taking advantage of modern information tools to help us with this analysis.”

To make improvements in this area, the FDA is planning an updated Adverse Event Reporting System (AERS). This system, AERS 2, will use more comparative analysis between different events, also taking medical literature into account, to better understand incidents’ broader significance. The agency will regularly report these results, Gottlieb said.

In February, an FDA official said the AERS pilot program was moving forward at a healthy pace (PIR, Feb. 1). “Currently, 50 percent of all expedited (15-day) adverse events reports are submitted electronically,” said Roger Goetsch, special assistant in the FDA’s Office of Drug Safety, at a Jan. 19 Drug Information Association meeting.

It is not only big companies that make up the roster of the 26 companies participating in the agency’s esubmissions AERS pilot, Goetsch noted.

And the number of esubmissions in the AERS program has grown at a refreshing pace, he said. In 2002 the agency received an average of 87 individual case safety reports per day — that number rose to 300 per day in 2004 and hit 500 per day last year, he said. — Stephen Langel, Michael Causey