When an internal report shows that the world's third largest generic drug maker routinely violated standard operating procedures, a lot of people should be concerned -- not just its employees and stockholders.
That's why prescription drug consumers and the general public should welcome the Food and Drug Administration's investigation of Mylan Inc. for possible violation of government-mandated quality controls.
Post-Gazette staff writers Patricia Sabatini and Len Boselovic reported Sunday that a confidential report by the Cecil-based company described how Mylan workers routinely overrode computer-generated warnings about potential problems with medications being produced at its Morgantown, W.Va., plant. The drugs made there are used to treat diabetes, cancer, epilepsy, depression, high blood pressure and other conditions.
The violations of procedure meant to ensure the safety and effectiveness of prescription drugs were uncovered in May and deemed "very serious" by the report. It said the actions occurred during all three shifts at the plant and involved "falsifying information" and "altering product."
After declining requests for interviews last week, Mylan released a statement Sunday night that said its investigation of "the issue" showed that its quality-control systems are actually working. "Our customers and stakeholders can rest assured that whenever there is even the slightest departure from an SOP [standard operating procedure], it will be dealt with immediately and effectively. This issue had no impact on the quality of our product," according to the statement.
Former FDA inspectors and industry consultants contacted by the Post-Gazette were not so assured. They reviewed Mylan's internal report and were left with concerns about the integrity of the plant's quality control.
Halfway around the globe, Mylan's Matrix Laboratories plant in India came under fire last week by the World Health Organization for "major deviations" from standard manufacturing practices during an inspection two months ago. In a letter to the company, WHO said that despite Matrix's planned or actual corrective action "issues of concern" remained.
While that plant may be beyond the FDA's reach, Morgantown is not. With 19 billion doses of medication produced there annually, the health of many people rests with the quality of Mylan's output and its ability to adhere to government standards.
No doubt eager to put this episode behind it, Mylan released a statement yesterday saying the FDA, after visiting the West Virginia plant Monday, "agreed that this was a minor standard operating procedures deviation" and that "all corrective actions were fully implemented." Two hours later a spokesman for the FDA told a different story: "The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue."
This investigation will go a long way to gauging the extent of the breaches of quality control. The millions of people who use drugs made by Mylan can be glad the FDA is on the case.