Monday, July 27, 2009


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:

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.'"


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.


  1. It is amazing that production workers were able to delete warning screens concerning vital medications. I wonder how many patients have been harmed.

    “Publicly, Mylan officials have refused to discuss or even acknowledge the matter.” However, as the 3rd largest maker of generic drugs that “treat diabetes, high blood pressure, depression, cancer, epilepsy and other conditions,” the question is, how long did officials know about this? Once aware, when did they intend to inform the FDA?

    What happened at Mylan is criminal. All involved should be dealt with accordingly. Hopefully, this sad story will be made very public.

  2. Based on the report, it looks like the goal was never to inform the FDA--to "handle things" internally, as the company claims it did.

    The article also hints that overriding warnings was policy at some level (unclear how far up), and certainly not a "rogue event"--all three shifts, codes being passed along, etc..

  3. More on the situation in today's Post-Gazette

    It appears FDA is getting involved. Company denies serious problem. Fierce Pharma, who deserve hat tip, refer to the situation as a "media brouhaha."

    One local newspaper seems a little small for a "brouhaha."

  4. Why would anyone believe Mylan’s statement?

    "Our customers and stakeholders can rest assured that whenever there is even the slightest departure from [standard operating procedures] it will be dealt with immediately and effectively."

    Their own internal reports indicated workers were overriding computer warnings. If, in fact, this is the case, Mylan and their workers are guilty of tampering with medicine and betraying the public’s trust.

  5. Since FDA regulations and commonsense require a warning system that cannot be tampered with by production workers without triggering a report, it's obvious that this practice was condoned by Mylan's Line Management and possibly higher level Management as well. However, as is always the case, Mylan will attempt to shift the blame to “rogue” production employees.

  6. According to Mylan's own report, the behavior was "pervasive," occurred on all shifts, and went on for two years. They did not act at all until a whistleblower did.

    You don't need a weatherman, I don't think.

  7. Further update on the situation from Reuters/Forbes at:

    Essentially, Mylan claims the FDA has found only "minor deviations." Its stock went up until the FDA itself said it had not formed any conclusions and "statements to the contrary are untrue."

  8. Further on the Mylan story--

    It was today announced that the company is "reshuffling" top management positions.

    Thus far, Mylan has denied any serious violations took place and that any problematic medications were distributed.

    If I read the article correctly, it looks like the person who had been in charge of regulatory issues has been promoted--to COO.

  9. Just for fun - here is a link to their code of ethics.....


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