Raised Eyebrow Alert – High Level FDAer Leaving For Mylan

Raised Eyebrow Alert – High Level FDAer Leaving For Mylan

May 1st, 2013 // 6:59 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Earlier today we reported on the FDA Deputy Commissioner at FDA for Global Operations and Policy Deborah Autor leaving the agency and taking a senior management role at Mylan Pharmaceuticals.

While it is very common for former FDA personnel to leave the agency and work in pharma, it is quite interesting to see such a high level FDA official exit the revolving door and work for a company that has had serious FDA compliance problems in the past. You might say, we’re a bit skeptical.

Deborah Autor – High Level FDA Official Goes Private Sector

Some of those problems were so serious that Mylan took desperate measures. Some of you may recall that Mylan Pharmaceuticals, in the 1980s, actually hired private investigators to spy on FDA. The company suspected that FDA was purposely stalling its drug applications.

Mylan later admitted that it did this because it was desperate. The scandal led to a Congressional investigation that showed a great deal of fraud and corruption in the generic drug part of FDA. Three agency employees admitted taking monetary bribes, and two generic companies actually did fake test results. Also, major cGMP violations were found at five other generic manufacturers.

This cause FDA to greatly revise its generic procedures and indictments were considered in the case.

And in 2009, Mylan ran into more serious FDA problems due to cGMP violations at its Morgantown WV plant in 2006, 2009 and 2011, including a warning letter. The Pittsburgh Post Gazette reported at the time that factory workers were ignoring safety mechanisms at the facility. The newspaper story stated that employees were overriding warnings generated by computer about the drugs they were making. FDA did appear to clear Mylan in the case. But a review of the original Post Gazette story shows that the operators were really ignoring safety software warnings. FDA seemed to conclude that while this was true, no defective products came out of it.

The CEO of Mylan, Robert Coury, denounced the reporting of the Post Gazette and called the story ‘baseless speculation.’ Mylan also said there was no evidence that there was any ‘data deletion’ involved, but the original newspaper story never claimed there was. The issue was ignoring safety warnings, which Mylan employees appeared to do.

Why are we bringing up this history of Mylan? Because now there is a high level FDAer going to a drug company with some questionable practices in the past. Some questions worth pondering:

  • How appropriate is it for a top level FDAer to go right into a company that has hired people to spy on FDA?
  • How well will she be paid?
  • What kind of treatment is Mylan going to be getting from FDA in the future, given that a high level ex-staffer works there?
  • Is she being hired so Mylan will have an easier time at the agency?

We are curious to see what others in the industry think about a top level FDA staffer going to work for Mylan Pharmaceuticals.

 

 


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