Questions about generic drug quality persist despite FDA reassurances. More than a year ago the Actavis Group had to voluntarily recall 800 million digoxin tablets because of doubts about the dose. A large Indian drug maker, Ranbaxy, also got into hot water because of allegations the company falsified data. The FDA banned importation of many Ranbaxy products as a result of its investigation. Other generic companies that have gotten into trouble recently include KV Pharmaceutical, Sandoz and Caraco. Over 100 different generic drugs have been recalled, resulting in short supply of certain medications such as the heart and blood pressure medicine metoprolol succinate.
Now, the largest maker of generic drugs in the U.S., Mylan, has been accused of failing to enforce adequate quality control procedures. Some workers apparently violated normal protocols to keep production lines running. According to the Pittsburgh Post-Gazette, the newspaper that broke the story, the unauthorized practices may have been going on for up to two years. The company produces nearly 20 billion doses each year. This comes on the heels of trouble at Mylan’s Indian subsidiary, Matrix Laboratories. The World Health Organization discovered major deviations in proper manufacturing practices last spring. All these drug problems are undermining confidence in the FDA’s ability to monitor generic pharmaceuticals. With increasing reliance on generic drugs to save money, it is imperative for the FDA to make sure that these lower-cost alternatives are absolutely equal to their brand name counterparts.
