Mylan Says It’s in the Clear With FDA. FDA Disagrees.


Published On: July 29th, 2009

MylanThis weekend, the Pittsburgh Post-Gazette ran a story that said workers at Mylan, the big generic drug company, “were routinely overriding computer-generated warnings about potential problems with the medications they were producing.”

Mylan contested the story immediately, and followed up with a statement this morning headlined “FDA Determined That All Accusations Were Unfounded.”

The company said it had contacted FDA over the weekend about the article. “As a result, the FDA visited the company’s Morgantown, W.Va., manufacturing facility Monday morning and has determined that the baseless accusations in the article were unfounded.”

But the FDA had a somewhat different take.

“This investigation involves allegations of compliance violations that the FDA takes very seriously. The investigation is on-going and the agency has formed no conclusions at this time. Statements to the contrary are untrue,” the FDA’s Assistant Commissioner for Compliance Policy, Office of Regulatory Affairs, said in a statement.

And now, back to Mylan! After the FDA came out its statement, a Mylan spokesman told Dow Jones Newswires that “our CEO would never have gone out with a statement like that without being informed of the closeout of the FDA inspection.”


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Mylan Says It’s in the Clear With FDA. FDA Disagrees.

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