Following close on the heels of the scandal surrounding the antibiotic Ketek, the FDA is looking at toughening rules to govern when and how fraud in a clinical trial is reported to the feds. Currently, drug developers are barred from knowingly using fraudulently obtained data but don't necessarily have to report the fraud itself. That may soon change, along with the standardization of paperwork, new rules governing patients' access to medications and a clarification on which adverse events must be reported to a monitoring committee. Several congressional leaders have been vehemently critical of the agency's handling of Ketek, an antibiotic that was approved despite the fraud surrounding a late-stage trial. The agency is likely to paint this as a continuation of their ongoing review of clinical trials, which it is. But the timing related to fraud won't go unnoticed.
- here's the report [1] from The Wall Street Journal for more (sub. req.)
PLUS: Two influential senators are planning to introduce legislation that would force developers to disclose data and set up a risk management program. Article [2]
Links:
[1] http://online.wsj.com/article/SB115084718281285744.html?mod=health_home_stories
[2] http://www.nytimes.com/2006/06/21/health/policy/21fda.html