
Mylan Inc. said today Chief Operating Officer Heather Bresch was promoted to president of the Cecil generic drug maker. Rajiv Malik, head of Mylan's global technical operations, replaces her as COO.
"Their track record of producing results and executing flawlessly as well as their exemplary leadership skills has earned them the right to these new roles," CEO Robert J. Coury said in a statement.
Ms. Bresch, 40, who joined the company as a data entry clerk in 1992, was named COO in October 2007. She is the daughter of West Virginia Gov. Joe Manchin.
Mylan, the world's third largest generic drug company, is being investigated by the U.S. Food and Drug Administration following a story in Sunday's Post-Gazette based on a Mylan internal report stating that workers at its Morgantown, W.Va, plant had routinely overrode computer-generated warnings about potential problems with the medications they were making. The report did not say what drugs were involved.
Mylan's report said the problem was "pervasive" and occurred on all three shifts at the plant, which makes an estimated 19 billion doses annually. It did not say how long the unauthorized practice had been going on.
The breach in quality control was "very serious," involving "falsifying information" and "altering product but did not affect the quality of the medications, the report stated. The report did not say how Mylan determined that quality was not compromised.
Former FDA inspectors and industry consultants who reviewed Mylan's internal report for the newspaper said the breach of protocol raised troubling questions about the integrity and oversight of the plant's quality control operations.
Mylan has not responded to numerous requests for comment. In a statement released late Sunday, the company said that "customers and stakeholders can rest assured that whenever there is even the slightest departure from [standard operating procedure] it will be dealt with immediately and effectively."
It reiterated that the issue "had no impact on the quality of our product."
When Mylan announced Ms. Bresch's promotion to COO in 2007, she stated that she had an M.B.A. degree from West Virginia University. An independent panel that investigated following a Pittsburgh Post-Gazette story questioning the degree concluded that after WVU officials were asked to verify the degree, they falsified Ms. Bresch's academic records to make it appear she finished the degree program and granted her a degree retroactively that she did not earn.
The degree was subsequently revoked and WVU's president, Michael Garrison, and the university's provost and business school dean resigned.
