Mylan and FDA: Which 'statements' are 'untrue'?

What's up at Mylan? After trading yes-you-did, no-we-didn't statements with the FDA over possible manufacturing violations at a key plant, the company announced that it's reshuffling its management.

You'll recall that over the weekend, the Pittsburgh Post-Gazette reported on an internal investigation of possible quality-control violations at Mylan plant in West Virginia. The company quickly lambasted the news story and defended its manufacturing practices. Yesterday, it sent out another release, saying that FDA had visited the plant and "determined that the baseless accusations in the article were unfounded."

The agency, however, begs to differ. Steven Solomon, assistant commissioner for compliance policy, told UPI that the agency hasn't reached any conclusions yet. "This investigation involves allegations of compliance violations that FDA takes very seriously," he said in an emailed statement to the news service. And as for the probe being wrapped up: Nope. It's not. "Statements to the contrary are untrue," he wrote.

Then, lo and behold, Mylan said it was the FDA's statement that was untrue. A spokesman told Dow Jones that "our CEO would never have gone out with a statement like that without being informed of the closeout of the FDA inspection," the Health Blog reports. If you're confused, there's a timeline at BNet Pharma.

Meanwhile, the company seems to be whistling past the graveyard, sending out an unrelated press release as if nothing untoward was going on. Here's the scoop on the management changes: COO Heather Bresch becomes president, and taking over her old job will be global tech operations chief Rajiv Malik. An ex-Teva-ite, Timothy Sawyer, joins the company as SVP of strategic corporate development; he had been in charge of global sales and marketing at Barr Laboratories, recently acquired by the Israeli generics giant.

- see the Mylan release on management changes
- check out Mylan's FDA statement
- read the UPI story
- check out the post at the WSJ Health Blog
- get the timeline at BNet Pharma