CERTs Look to Re-Assert Larger Role in Post-Marketing Surveillance
This article was originally published in RPM Report
There is growing pressure on FDA and Congress to create public-private partnerships for enhanced postmarketing surveillance. The Agency for Healthcare Research and Quality already runs an existing network of academic centers that could fit the bill nicely.
You may also be interested in...
The Reagan-Udall Foundation is an early priority for FDA in implementing the landmark legislation enacted by Congress in 2007. It is also a lightning road for criticism from Congress about the agency's relationship with regulated industry. We asked foundation chairman Mark McClellan for a status report.
The message from RPM's FDA/CMS Summit Conference: if you want to handicap the effect of the continuing drug safety debate around FDA, you can track the progress of the Kennedy-Enzi bill through Congress - and listen to the tone of the comments from the agency's top managers and its critics. Both will tell you what's at stake for pharma in 2007.
FDA's senior management is worried that it may have created a political Frankenstein when it called for an outside review of the agency's role in drug safety decisions by the Institute of Medicine. The agency asked for the study to take the heat out of Congressional efforts to split up safety and efficacy reviews. The committee has shown interest in the arguments to create new publicly-funded centers for post-market trials.