The Food and Drug Administration is about to launch the first generic-drug-testing program in America’s history. Thank goodness. We have relied upon the honor system for far too long.
Physicians, pharmacists and patients assume that the FDA has been testing the quality of generic drugs for decades. That is rarely the case. The agency relies upon generic-drug manufacturers to perform their own quality testing. This dependence upon the integrity of these companies and their self-generated data has led to poor-quality products.
In the past few years, there has been a series of damaging revelations about quality control, especially in foreign countries. A whistle-blower at the largest Indian drug company, Ranbaxy, notified the FDA in 2007 that workers at the company were “cooking the books” to make their generic drugs look better than they actually were.
The FDA inspected one of the Ranbaxy plants in December 2004 and gave it a clean bill of health. This was during the time the whistle-blower was uncovering evidence of serious systemic problems at the company.
Eventually, the FDA discovered that Ranbaxy facilities did not have proper standards for quality control or record keeping. The company eventually pleaded guilty to felony charges related to drug safety and paid $500 million in fines. This was the largest such settlement with a generic-drug manufacturer. At the moment, no drugs manufactured by Ranbaxy in India are allowed into the U.S. market.
The Ranbaxy debacle is not an isolated event. Another Indian drug company, Wockhardt, ran afoul of the FDA when an inspection last year uncovered violations of good manufacturing practice at its Waluj facility. An import ban was imposed on products from that plant.
A reader of our newspaper column noted that her mother appeared anxious and depressed after being switched to Wockhardt’s bupropion. She noticed that the pills smelled terrible, a sign of chemical deterioration.
Quality control problems do not always originate abroad. A Houston testing laboratory, Cetero Research, analyzed data for both generic and brand-name drug companies. Although the FDA inspected the lab on numerous occasions, it found no serious flaws. But a whistle-blower from within the company revealed in 2009 that some of the chemists were falsifying data. Eventually, the FDA concluded that drug tests between April 2005 and June 2010 were unreliable.
With so many questions about quality control, it is not surprising that physicians, pharmacists and patients have begun to question the FDA’s ability to monitor pharmaceutical manufacturing. That is why the new $20 million generic-drug-testing program is so welcome. This program will enlist leading academic centers to analyze samples of generic antidepressants, anti-seizure medications, heart drugs and immunosuppressants.
Such a program, if well run, should allow the FDA to detect problems before they cause harm to the public health. Perhaps the new Office of Pharmaceutical Quality can restore trust in generic medications.