This week's document: Establishment inspection report on Sanofi-Aventis
Originating agency: FDA Center for Drug Evaluation and Research (CDER)
Document date: May 13, 2010
Every Friday, POGO will strive to make one document available that we or others have obtained through the Freedom of Information Act (FOIA), especially documents that have not previously been posted online. Some of these documents will be more important than others, some may only be of historical interest— although relevance is in the eye of the beholder. POGO is doing this to highlight the importance of open government and FOIA throughout the year.
By NICK SCHWELLENBACH
French pharmaceutical giant Sanofi-Aventis has had its share of self-inflicted problems. Take for instance, the case of Sanofi’s Ketek antibiotic. As Jim Edwards at CBS’s BNET wrote earlier this year:
Sanofi knew in October 2001 that one of its main researchers on the drug was probably faking her data. That researcher was indicted for research fraud in April 2003. Yet in April 2004, the FDA approved Ketek for sale even though both it and Sanofi knew the data on which the approval was based was entirely bogus. In 2007, after 53 cases of liver failure including four deaths, the FDA all but withdrew Ketek from the market.
Finally, after coming under scrutiny from Senator Chuck Grassley (R-IA), the FDA in late 2007 issued a warning letter to Sanofi’s handling of its Ketek antibiotic that criticized it for, as Pharmalot’s Ed Silverman put it:
failing to ensure investigators were in compliance and for failing to follow-up problems with data analysis and documentation; failing to monitor clinical trials; failing to select qualified investigators; and failing to ensure protocols were followed.
Sanofi has been up to some other wonderful things as well. Earlier this year, the Senate Finance Committee released documents that suggest “medical societies and doctors [including a researcher at Duke University] with financial ties to Sanofi served as components of a coordinated public relations strategy to use FDA’s citizen petition process to prevent or delay generic alternatives to its blockbuster drug Lovenox from coming on the market.” Classy.
But I digress.
Today’s FOIA Friday document is a 58-page May 2010 FDA Center for Drug Evaluation and Research (CDER) post-market surveillance and epidemiology “establishment inspection report” of Sanofi. There were 148 of these kinds of CDER inspections during fiscal years 2009 and 2010, according to a search for these inspections in the FDA’s inspection database. But only three of the 148 of these inspection reports are classified as “official action indicated” or OAI (rather than “no action indicated” or “voluntary action indicated”), which means the FDA feels it has to force a company to make changes in response to “objectionable conditions” that are found. The inspection of Sanofi was one of those three OAI reports.
- The CDER “inspection disclosed that not all ongoing postmarketing studies had been included in NDA [New Drug Application] Annual Reports for Apidra, Elitek, Eloxatin and Ketek.”
- “In addition, other clinical studies that were either ongoing or completed were reported late to the NDA Annual Reports for Ambien, Apidra, and Eloxatin. They were mainly foreign studies.”
- “There were about 185 initial 15-day reports that were submitted late for the time period of January 1, 2009 to March 31, 2010.”
Nick Schwellenbach is POGO’s Director of Investigations.