“The fact that FDA did not require you to conduct a tQT for exenatide to support the safety of Bydureon did not relieve you of your obligation to submit those data once they became available.”
So wrote FDA’s John Jenkins (Director, CDER’s Office of New Drugs) in May of 2011.
FDA documents detailing its review of the diabetes drug Bydureon exenatide indicate the agency delayed approval by a year and a half after concluding the drug’s sponsor, Amylin Pharmaceuticals Inc., had intentionally and deceptively withheld data from a QT study that agency officials believed raised serious concerns about the product’s safety.
In fairness to Amylin, they have a different perspective on the situation. (A solid review of the story is in BioCentury and is worth a read.)
Many issues arise from this situation. One is clearly related to the current imbroglio over the call from Ben Goldacre, et al. for complete clinical trial transparency. A key take-away from the Amylin story is – you can run but you can’t hide. Or, perhaps more precisely, you can’t hide for long.
More importantly, the Amylin situation points out yet another reason why the FDA needs more funding – vigilance counts.
And costs.
Amylin's chagrin, spin, and original sin
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