GlaxoSmithKline (GSK) has committed a string of business execution failures—some of the most outrageous failures that I could ever have imagined in the pharmaceutical industry. The bottom line: GSK has agreed to pay a fine of $750 million for producing and selling “adulterated and improperly made drugs.”
What is GSK admitting happened at its now-closed manufacturing plant in Cidra, Puerto Rico? The plant:
o Produced medications that were mislabeled
o Produced defective medications—too weak or too strong
o Mixed dosages of the same drugs in the same packaging, e.g., 10 mg and 30 mg tablets
o Produced drugs contaminated with micro-organisms
According to 26OCT10 MSNBC.com article “Drug maker to pay $750 million for defective meds,” “A big factor in the lawsuit was the role of a former quality assurance manager for GSK who became a whistleblower after she was fired.” Her job was to monitor products produced and speak up about non-conformity to standards. This woman spoke up and it cost her her job.
Pharmaceutical products are produced under GMP—good manufacturing practice–standards. What does this mean?
Rigorous testing and quality control practices must be continuously applied for every lot of drugs produced. This is to ensure consistency in the drug formulation, quality, etc. Documentation must be maintained proving that the testing was performed by a specific employee, the date and time of the testing, the serial number of test equipment used, the last calibration date and next calibration date of each piece of equipment used, the test results, etc. All of the test information is captured. It is not permissible to modify any information in the test process—any changes must be crossed out (not erased) and signed and dated by a supervisor and the person performing the test.
For example, if you manufacture a product called “aspirin,” there are rigorous tests that must be conducted to prove the product is indeed aspirin and meets the FDA requirements for what an aspirin is. This would include things such as confirming that an aspirin tablet contains all right ingredients in the correct proportions but will also dissolve within a certain period of time enabling the drug substance “aspirin” to be absorbed into the human body through the digestive system.
What conclusion can we reach? GSK knew about the problems and chose to look the other way. GSK did not do the right thing even when it had the chance.
This fine was not the result of an isolated incident. This was an out of control plant, a plant that has since been closed.
The pharmaceutical and biotech industries attract competent, brilliant, compassionate, and caring people—people with a great deal of integrity. I’m sure those in the industry find what happened at the Cidra GSK manufacturing plant to be as abhorrent as I do.
GSK has a moral, ethical and fiduciary obligation to produce drugs that conform to industry GMP standards. For this horrific business execution failure, Gardner & Associates Consulting enters GlaxoSmithKline in the Business Execution Hall of Shame.
Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com
© 2010 Gardner & Associates Consulting