It's Not Mylan's First Quality Control Beef With FDA

Last Updated Jul 28, 2009 5:06 PM EDT

If you're following Mylan's fight with the FDA over whether the agency did or did not give the generic maker a clean bill of health at its Morgantown, W.Va., factory, you'll be interested to know that this is not the first time the FDA has frowned upon the company.

Back story: The Pittsburgh Post-Gazette published a must-read story on Sunday detailing workers in Mylan's drug factory overriding computer warnings designed to alert staff that the drugs they were making were faulty. Mylan denies anything's wrong, but the WSJ reports that the FDA is taking the report "very seriously." Mylan has continued to insist that the FDA has given it the all-clear.

It turns out Mylan and the FDA have a little history between them. In March 2006 the FDA ordered a nationwide recall of Mylan's Carbidopa and Levodopa extended-release tablets, citing this reason:

The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life.
Then, in 2008, the FDA moved to disqualify a doctor involved in research performed for Mylan on Nebivolol, a hypertension drug. The FDA told the doc:
... we believe that you have submitted false information to the sponsor or FDA in required reports and repeatedly or deliberately violated regulations governing the proper conduct of clinical studies involving investigational products
Here's the tick-tock on the current fight:
  • Sunday July 26, 2009: ... 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.These alerts, triggered during the making of tablets and capsules, warn production workers that the medications may fail to meet specifications for weight, thickness or hardness ...
  • Mylan responded later on July 26, 2009: "An article published today about an issue related to a Standard Operating Procedure (SOP) was based on improperly obtained documents, uninformed third-party commentary and anonymous sources. Simply put, our investigation of the issue demonstrates that our quality systems are working, not the contrary.
  • Mylan then said on July 28, 2009: ... the FDA visited the company's Morgantown, W.Va., manufacturing facility Monday morning and has determined that the baseless accusations in the article were unfounded. The FDA noted there was no evidence of any data deletion.
  • The FDA said on July 28: "This investigation involves allegations of compliance violations that the FDA takes very seriously. The investigation is on-going and the agency has formed no conclusions at this time. Statements to the contrary are untrue," the FDA's Assistant Commissioner for Compliance Policy, Office of Regulatory Affairs, said in a statement.
  • Mylan said in response: ... a Mylan spokesman told Dow Jones Newswires that "our CEO would never have gone out with a statement like that without being informed of the closeout of the FDA inspection."
What's really going on? Here's a theory: Note that Mylan's statement focuses on "data deletion," but it's not just data deletion that's at issue.