Washington Editor
WASHINGTON - The FDA is partnering with the Massachusetts Institute of Technology to create a better safety monitoring system than the current voluntary reporting process.
Both parties will collaborate on an automated system that mines existing government and private insurance databases to seek out irregularities in post-approval drug and device usage. That's expected to allow the FDA to more quickly unearth safety problems as product use increases in the general public.
The regulatory agency, said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, needs "to do more to monitor for safety when it comes to using new medicines." His comments were prepared for a speech at the university in Cambridge, Mass., in which he unveiled the partnership. "One of the shortcomings of our approach is that we are not taking advantage of modern information tools to help us with this analysis."
Current safety monitoring techniques are time-consuming because they rely on manual assessments of reports voluntarily submitted to the FDA, and those submissions sometimes don't arrive until a significant amount of time has passed since an adverse event occurred. That also leads to underreporting, Gottlieb said.
Concerns over the existing system have snowballed in the two years since the market withdrawal of Vioxx, and some in Congress have floated legislation to change the structure of the FDA's safety office in order to get better results. Consumer protection groups also have clamored for an overhaul.
But Gottlieb and others at the agency have resisted such sweeping changes, instead working to develop improvements to the existing post-approval safety setup. The system to be developed with MIT's Center for Biomedical Innovation would be based on existing methods to identify infectious disease outbreaks, bioterrorism attacks and bird flu.
Gottlieb said he's "sure that we can be making better use of sophisticated information tools" to support efforts around post-approval monitoring, so the new initiative would be designed to recognize patterns that indicate unexpected efficacy or problems with safety.
More Von Eschenbach Opposition
The latest twist around Acting FDA Commissioner Andrew von Eschenbach centers on a group challenging his nomination because of the agency's recent compromise on the Plan B contraceptive product. A group called Human Life International, a Catholic priest-led pro-life organization, called on President Bush to withdraw the nomination because of the FDA's move to make Plan B available without a prescription to women 18 and older. Labeling the product an "abortion-causing drug," the group implored Bush to instead name "a health care professional who respects the dignity of the human person."
Action on the nomination could come next month when congressional members return following this month's recess.
Top NCI Post To Be Filled
The president intends to appoint John Niederhuber to lead the National Cancer Institute (NCI) on a permanent basis. Already he has had operational control of the research center since von Eschenbach was nominated to be FDA commissioner.
A surgeon and researcher, Niederhuber previously served as the NCI's deputy director and deputy director for translational and clinical sciences.
He will be its 13th director. Part of the National Institutes of Health in Bethesda, Md., the NCI is the only NIH component whose leader is directly appointed by the president.
