Pharmalot’s Scoop: Januvia® Deemed “Misbranded” — And In Violation of FDA Safety Rules


Ed has a great long story on the Merck cock-up of today, unduly delaying an FDA required post-marketing study, related to safety of Januvia® (sitagliptin). Do go read all of Ed’s insights, then come back here. [For my part, I’ll note that, in its just filed SEC Form 10-K (table on page 49) Merck sold over $3.3 billion worth of Januvia in 2011, up almost a billion dollars, compared to 2010. This regulatory non-compliance potentially jeopardizes that revenue stream. Astonishing.]

From the FDA’s warning letter to Merck, then:

. . . .FDA has not been provided sufficient information to determine whether the proposed independent study is adequate to satisfy the PMRs.

Therefore, you have submitted neither a study protocol for a new rodent study, nor a final study report for the independent study that you proposed would satisfy the PMRs. You have not provided an adequate explanation for the cause of the delay of either of the milestones in the timetable for completion of the postmarketing requirement, nor did you propose to revise the agreed-upon timeline.

As a result, you are more than 20 months late in achieving the June 15, 2010 final protocol submission milestone and more than 8 months late in achieving the final protocol submission milestone in the timetable, and you have not demonstrated good cause for these delays.

Conclusion and Requested Action

Under section 502(z) of the Act [21 U.S.C. 352(z)], your product is considered misbranded because you are in violation of a postmarketing requirement (PMR) established under section 505(o)(3) of the Act. You have failed to comply with the approved timetable and periodic report submissions of section 505(o)(3)(E)(ii) of the Act and failed to show good cause for not conducting the additional testing required to further assess whether a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with the use of sitagliptin, represents a public health risk.

Failure to promptly correct this violation may result in regulatory actions by the FDA without further notice. These actions include, but are not limited to, civil money penalties. Other federal agencies may take this Warning Letter into account when considering the award of contracts. In addition, civil money penalties under section 303(f)(4) of the Act [21 U.S.C. 333(f)(4)] could be levied for a maximum of $250,000 per violation, with the possibility of additional penalties if the violation continues uncorrected. . . .

Bewteen Ed Silverman’s Pharmalot, and this joint, we will keep you posted. [My September 2009 background on the Januvia®/pancreatitis concerns.]

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