The debate over Avandia could have far-reaching consequences for other drug sponsors as the crux of the controversy focuses on clinical trial data and their interpretation in meta-analyses.

The “kitchen sink” approach to informed consent should give way to an ongoing process that is adjusted as necessary throughout a clinical trial, the Institute of Medicine (IOM) recommends in an interim report to the FDA.

More than half of all clinical trials for FDA-regulated drugs and biologics were conducted outside the U.S. in fiscal 2008, yet the agency inspected fewer than 1 percent of foreign trial sites, a report by the HHS Office of Inspector General (OIG) concludes.