Last Updated Aug 17, 2009 12:00 PM EDT
The P-G reported that workers at the factory were overriding safety mechanisms at the plant. Mylan insisted nothing was wrong. The FDA investigated and has cleared the plant to continue production.
Here's Coury's statement about the FDA clearance. It says the newspaper published "unfounded and highly inaccurate allegations." Coury himself was quoted in it saying:
The baseless speculation that was caused by a highly irresponsible and sensational newspaper article with a biased agenda was entirely unnecessary."Baseless"? "Biased"? If you read the P-G report carefully, you'll see that the story's description of what happened at the plant and the FDA's statement actually dovetail. Here are the crucial parts of the original P-G story:
[Workers were ] routinely overriding computer-generated warnings about potential problems with the medications they were producing.
Mylan's quality assurance team had concluded that no medications were compromised
In some cases, the red screen turns out to be a false alarm of sorts.Now look at what the FDA said:
Mylan appeared to conduct an "adequate investigation" of the matter, with no evidence that there was any adverse impact to affected product lots.
"No data was deleted, and the audit trails were intact for each instance where the software was overridden by the operator," according to the agency's statement.That last sentence is key, because it confirms the nut of the P-G story: that operators were indeed overriding the safety software used to product Mylan's pills. The FDA merely concluded that although they were doing that, no defective meds were produced. The P-G story may have been somewhat alarmist, but alarmism is reasonable when you discover -- and the FDA confirms -- that drug workers are overriding safety protocols.
And the FDA's statements also explain Mylan's strident-but-qualified insistence on July 28 that "there was no evidence of any data deletion." As BNET noted at the time, that denial was interesting because the nut of the P-G story wasn't about data deletion, it was about the thing that the FDA actually found (but declared harmless) the overriding of computer controls.