Quoted from http://www.forbes.com/sites/edsilverman/2012/02/29/waiting-for-godot-merck-the-fda-and-post-marketing-studies-that-never-arrive/
Waiting For Godot: Merck, The FDA And Post-Marketing Studies That Never Arrive
2/29/2012, Ed Silverman
Anyone who thought that the drug approval process could be easily improved by placing greater emphasis on post-marketing studies has only to look at a nasty clash between the FDA and Merck to realize the notion may be fraught with peril.
The agency, for those who did not follow the news, recently sent the drug maker a warning letter for failing to proceed with post-marketing studies for its Januvia and Janumet diabetes treatments. The studies were required to assess the risk of acute pancreatitis after 88 cases were reported between October 2006 and February 2009.
The FDA had sent Merck a complete response letter in October 2009 to say that scrutinizing adverse events reports would not be sufficient to gauge the risk of acute pancreatitis and that, instead, a three-month pancreatic safety study in a diabetic rodent model treated with sitagliptin would be required. Januvia is also known as sitagliptin; Janumet combines this drug with metformin.
And so, a timetable was established that required the drugmaker to submit a final protocol by June 15, 2010; followed by a study completion date on March 15, 2011, and a final report submission on June 15, 2011. Completing the three-month study was specified as a condition for supplemental new drug approvals from the FDA. Yet, Merck blew past each deadline.
Moreover, the drugmaker proposed to satisfy the post-marketing requirement by submitting study data from another independently conducted investigator-initiated study, not the agreed-upon studies required by the FDA. But even then, Merck was somehow unable to meet deadlines for submitting information.