The Food and Drug Administration yesterday said its probe of Mylan Inc.'s generic drug making plant in Morgantown, W.Va., was expected to take another few weeks.
FDA spokesman Christopher Kelly said he could not be more specific about a timeline for completing the investigation into quality control issues at the plant, other than it should be "toward the end of the next few weeks."
The FDA launched the probe at the world's third biggest generic drug company following a July 26 story in the Pittsburgh Post-Gazette citing a Mylan internal report that said workers sidestepped computer-generated warnings about potential problems with the medications they were making. Mylan's report called the quality control breach "pervasive" and "very serious," involving "falsifying information" and "altering product." The breach did not affect the quality of any medications, the report stated.
Mylan Chairman and CEO Robert Coury has repeatedly insisted that the FDA probe was over and that the plant had been cleared, despite FDA statements to the contrary.
Mylan issued a news release the morning of July 28 saying regulators had visited the plant the previous day and had "agreed that this was a minor standard operating procedures deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan."
"The FDA determined that all accusations were unfounded," the release stated. "I want to thank the FDA for responding as quickly as it did," Mr. Coury said in the statement.
Mylan's statement was refuted two hours later by FDA assistant commissioner Steven Solomon.
"The investigation is ongoing and the agency has formed no conclusions at this time," Mr. Solomon said. "Statements to the contrary are untrue."
Two days later, in a conference call with Wall Street analysts, Mr. Coury called the matter "a short-term distraction."
"Let me be clear, we stand by everything said in the press release that we issued Tuesday," he said.
He told analysts that an inspector visited the Morgantown plant Monday, July 27, "and concluded the inspection by conducting a close-out meeting."
Mr. Coury concluded by saying he would not be taking any questions from analysts on the matter.
Later that day, Mr. Coury fielded questions on CNBC, saying he "did not jump the gun" when he had said the probe was over.
"I want to thank the FDA for moving so expeditiously," he added.
Mylan has not responded to repeated requests from the Post-Gazette for comment.
The company last week told other media and the investment community that the FDA's Mr. Solomon must have been misinformed about the investigation.