Reshuffle at the top as Mylan deals with quality queries
pharmafile | July 31, 2009 | News story | Manufacturing and Production, Research and Development |Â Â MylanÂ
US pharmaceutical firm Mylan has promoted chief operating officer Heather Bresch to the post of president as it rides a wave of controversy over quality issues at its manufacturing facility in Morgantown, West Virginia.
The world's third-largest generic drugmaker has been defending itself over allegations in a US newspaper that production staff systematically ignored quality control tests yielding out-of-specification results, and that the incidents themselves were not recorded.
On July 28 the firm put out a statement refuting the allegations made in the Pittsburgh Post-Gazette, saying they were 'baseless and unfounded', and indicating that the US Food and Drug Administration (FDA) had inspected the facility the previous day.
The FDA "noted there was no evidence of any data deletion. All data was reviewed and was present and accounted for," said Mylan. The company also said that the offending actions were "minor … fully investigated and all corrective actions were fully implemented by Mylan".
The FDA seems to have a different interpretation, however. Steven Solomon, assistant commissioner for compliance policy, told the UPI news service that the investigation was still ongoing and no conclusions had been reached. Mylan insists that its chief executive Robert Coury would never have released the statement without assurances from the FDA that the issue was closed.
The company remained tight-lipped on the matter ahead of a conference call to discuss its just-released second-quarter results with analysts, but it is just the latest in a string of pharmaceutical manufacturers taken to task over quality in a clampdown by the FDA.
Another generic drugmaker, Caraco Pharmaceuticals, has seen production at three facilities in Michigan suspended by the FDA in the wake of a series of product recalls. The firm's chief executive, Daniel Movens, resigned in the wake of the seizure and in the interim has been replaced by Jitendra Doshi. Caraco is a subsidiary of Indian company Sun Pharmaceutical.
Meanwhile, it has been business as usual at Mylan, releasing second-quarter results yesterday that topped expectations with a $58 million net profit on revenues up 6% to $1.27 billion. The sales increase was helped by Mylan's recent acquisitions of Merck KGaA's generics business and Indian company Matrix Laboratories. The firm also raised its full-years sales and earnings guidance on the back of the figures.
In the latest executive reshuffle, Mylan also appointed Teva Pharmaceuticals' Timothy Sawyer as its senior vice president of strategic corporate development. Rajiv Malik, formerly head of global technical operations at the company, takes on the COO role.
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