"CATASTROPHICALLY SERIOUS"?

Will Mylan Be the Next Big One?

Almost lost in the news was a report yesterday (Sunday, 7/26) that has the potential to be Act I of a major drug disaster. The article appareared in the Pittsburgh Post-Gazette (hat tip to FDLI blog) and can be accessed at:

http://www.post-gazette.com/pg/09207/986516-28.stm

To excerpt briefly from the article:

"MORGANTOWN, W.Va. -- Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.
Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.
But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

The violations of standard operating procedure at the world's third largest generic drug company, uncovered May 11, were "very serious," the report stated, involving "falsifying information" and "altering product."

The report said the practice was "pervasive," occurring on all three shifts at the plant, which makes roughly 19 billion doses of medication annually. The drugs are used to treat diabetes, high blood pressure, depression, cancer, epilepsy and other conditions.

The report did not say how long the unauthorized practice had been going on at the plant, which employs about 2,000. One worker interviewed by company investigators indicated it had been happening for at least two years.

Former Food and Drug Administration inspectors and industry consultants say the widespread breach of protocol raises troubling questions about the integrity and oversight of the plant's quality control operations."I've never before seen anything like this, that has reached this level of cheating," said James Akers, a longtime pharmaceutical industry consultant in Kansas City, Mo., who reviewed the document for the newspaper. "



To say the obvious: 19 billion doses annually is a lot of doses. And even a small percentage of "altered product" from the third largest generic drug manufacturer could impact enormous numbers of people.

The article further notes that Martha Bennett, a former senior compliance officer at FDA, noted the internal report "descriibed multiple serious FDA violations, including the falsification of batch production records." By law, such records are required to be maintained. That is the only way to track which batches might be misbranded, or worse.

Bennet continued, re: the "serious FDA violations": "I can't determine from this report whether it's catastrophically serious." That is, whether and how much of the relevant meds got onto the market. But the article suggests that the problem had been going on for a couple of years, and there has been no recall to this point.

The article notes that Mylan has refused public comment. Read the article and make your own call about what we know about the company's response at this point. It suggests that FDA was never notifiied. And it ends with this:

"Employees who provided information to the newspaper did so on the condition that they remain anonymous. They said the feared losing their jobs at Mylan, one of the Morgantown region's largest and best-paying employees.

Some of them are bracing for more fallout.

'There's an overwhelming feeling this is not over," said a source close to the situation. "It's like a slow boil. Everyone is waiting to see what happens next.'"


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Addendum: It is reported today that FDA will initiate an investigation of this situation. Mylan has explicitly denied that any misbranded drugs have been distributed.