MDS MISREPRESENTED STUDY STATUS, FDA SAYS

The FDA has accused life sciences company MDS of misrepresenting the status of studies it was conducting and said it found problems with the analytical methods the company used in more than 30 studies of six different drugs, according to an agency warning letter issued Aug. 31.

The letter, which was posted to the FDA's website Sept. 11, followed inspections conducted at company facilities in Saint Laurent, Montreal, and Blainville, Quebec, during which the agency said it found "widespread problems" at both locations. The inspection was part of the Bioresearch Monitoring Program, a standard-setting initiative for clinical trials.

The letter provided a number of examples of problems with specific drug studies MDS conducted. At Blainville, "several studies for multiple sponsors had large inconsistencies between original and repeat results for incurred subject samples," the letter said. In one study, "more than 40 percent of the repeat results differed from the original results by approximately 20-275 percent."

In another example cited in the warning letter, MDS discontinued a certain study method in August 2005 that had yielded "plasma concentrations significantly higher (three to 20 times) than those reported by other laboratories conducting similarly designed bioequivalence studies in healthy subjects," but it did not tell the sponsors that data generated with this method were invalid until May 2006, two months after an FDA inspection.

The warning letter can be accessed at www.fda.gov/cder/warn/2006/MDS_Pharma.pdf (http://www.fda.gov/cder/warn/2006/MDS_Pharma.pdf).