Generic Drug Plant Cited for Safety Violations

Morgantown West Virginia is a sleepy community of nearly 30,000 residents and is best known as the home of West Virginia University. It’s also home to the world’s third largest manufacturer of generic drugs. Earlier this spring, Mylan Inc. halted production of its generic drugs. The May 11th discovery involved violations of government mandated quality control procedures. An internal company report obtained by the Pittsburgh Post-Gazette details reports about employees overriding computer generated warnings concerning problems with drugs they were manufacturing. The report noted that quality control procedures had been circumvented and products were adulterated. To make matter worse, the report indicated these were not isolated issues. They were happening on all shifts for the last two years. Mylan Inc. manufactures approximately 19 billion doses of medications annually that are prescribed to treat high blood pressure, diabetes, cancer, depression, among other diseases. According to an article in the Pittsburgh Post Gazette, “I’ve never before seen anything like this, that has reached this level of cheating,” said James Akers, a longtime pharmaceutical industry consultant in Kansas City, Mo., who reviewed the document for the newspaper. “It certainly indicates a significant problem within their company.” While Mylan officials contend that their products remain safe, government officials remain skeptical. “The batch record is there to tell the story, the good, bad and ugly,” said Robert Lewis, a regulatory consultant in Georgia and former FDA investigator who also reviewed Mylan’s report. “Whenever there is a problem [during production] it should be noted and discussed and evaluated.” Experts said there was not enough information in the report to judge whether any drugs going out the door had been compromised. The report described “serious [FDA] violations, no question about that,” Ms. Bennett said. “To cheat, if you will, with an electronic record and say it is pervasive on all three shifts … is very, very serious. “But I can’t determine from this report whether it’s catastrophically serious,” she said, meaning whether the breaches resulted in tainted medications. Read more: