Are problems confined to India?
Not at all. "The problems FDA investigators encounter in India are similar to those seen around the world in manufacturing," according to an FDA representative. For example, in the last year, the FDA has sent warning letters about manufacturing or packaging violations not only to companies with plants in India, but also to companies operating plants in Australia, Austria, Canada, China, Germany, Japan, Ireland, and Spain. Common issues include inadequate testing and quality checks, inconsistencies in data collection, and contaminated products.
In particular, imports of drugs and medical devices from China increased by nearly fivefold from 2007 to 2013, and the FDA is scrambling to keep up. Our review of FDA import alerts reveals that the agency sanctioned about as many Chinese factories in the last five years as it did those in India. (Under these alerts, products can be stopped from coming into the U.S. until the importer proves that they comply with relevant laws and regulations.) As in India, the FDA is working with the Chinese government and plans to increase staff—from the current eight U.S. officers to 27—to conduct timely inspections of more Chinese plants and other tasks.
Are name-brand drugs safer?
No.
Manufacturing standards are the same for brand-name and generic drugs. In fact, many brand-name drugs are produced overseas as well, often in the same plants as the generic equivalents.
And manufacturing problems also occur in connection to brand-name drugs made by U.S. companies in this country. For example, in what is probably the largest related series of drug recalls in U.S. history, according to an analysis by QuarterWatch, a drug safety publication from the nonprofit
Institute for Safe Medication Practices, millions of bottles of over-the-counter medications, including Tylenol and Motrin, were yanked from pharmacy shelves beginning in September 2009 by Johnson & Johnson's McNeil Consumer Healthcare subsidiary, headquartered in Fort Washington, Pa. At least one of the manufacturing plants at the center of the recalls was in Pennsylvania; another, in Puerto Rico.
The FDA had received more than 2,000 reports of adverse events associated with the recalled products, according to the agency.