cGMP Consultant Paid $1000 a Day For Assembling Binders? Whispers Around the Pharmaceutical Water Cooler
April 16th, 2013 // 11:56 pm @ jmpickett
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April 16, 2013
Last month, we wrote a controversial cGMP story that posed the following question: Is GSK pressure on FDA influencing Hospira 483 failures? According to our anonymous source in the industry, GSK has used its influence on FDA to put regulatory pressure on Hospira to drop the stock price so GSK can acquire the company at a lower price.
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We have other sources in the pharmaceutical industry that claim this type of dirty dealing is not uncommon in the industry. Some of the whispers we have heard from sources include the following:
- One consultant we know told us that he knows for certain of two situations where FDA warning letters were issued for cGMP violations ‘due directly to competitors complaining to FDA.’
- According to another consultant, he heard from consultants at Hospira at Rocky Mount that Hospira was changing audit reports and keeping original signatures on them.
- This source also told us that there is a certain consulting company that FDA often tells companies to hire when they get a 483. So, when that consulting firm drops a pharmaceutical company, FDA often wonders why. He wonders how exactly this consulting company got this cozy arrangement? He said he spoke to many consultants that would never work at that company. ‘They want to do great work and want to be the best in the field, not just a name on an organizational chart to show FDA that a company is fixing a problem.’
- ‘Complaints are what fueled the Hospira debacle. It all starts/ends with good leadership. You can have a million cGMP consultants, but if management has a ‘make money at all costs’ idea, the consultants are not the problem.’
- Most consultants hired by companies with 483 or warning letter problems are good people and good at what they do. The problem usually comes from, what one consultant termed, ‘arrogant people who run some pharmaceutical companies.’ They don’t talk to each other or other departments, they don’t answer emails and phone calls from consultants in the building. They have meetings where no action items are discussed, there is now follow up.
- Some consultants end up doing menial tasks at pharmaceutical companies that regular employees simply do not want to do. “How can you have CAPAs that are 5 years old and never acted upon?’ Also, consultants are just brought in to put out one fire after another day after day so that nothing really structurally positive gets done.
- Another consultant on this same theme told us that he was actually paid $1000 per day to put together validation binders. Not to do the work – simply to assemble the binders! On another gig, he was paid $1000 a day to do simple inspections of boxes of product. Again – work that employees did not want to do.
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