Last week, drugmaker Novartis issued a recall of generic versions of the popular heartburn medication Zantac. The Food and Drug Administration recently announced that the drug’s active ingredient, ranitidine, had been contaminated with a carcinogen known as NDMA. On Monday, CVS pulled Zantac and its generics from its shelves; Walgreens had already stopped selling the drug earlier.
This recall will impact patients suffering from a variety of excess stomach acid conditions. But it’s the safety of the generic drug supply as a whole that should give all Americans heartburn.
Congress is currently focusing on a legislative effort to reduce the out-of-pocket costs of brand name prescription drugs. This is a worthy effort. Yet it shouldn’t overlook the other pressing prescription drug problem: the safety risks posed by many generic drugs, which make up roughly 90% of the drugs Americans take.
Ranitidine is just the latest in a string of generic prescription drug safety contaminations in recent years. Last year, the FDA announced that the same carcinogen contaminated the popular blood-pressure medication valsartan, spurring a massive recall that affected tens of millions of patients.
The biggest prescription drug crisis of recent years was the 2008 contamination of heparin, a widely used blood thinner. The FDA estimates that 149 Americans died and many hundreds more were seriously injured as a result.
What’s responsible for the repeated drug safety lapses? The offshoring of the American drug supply to China and, to a lesser extent, India during the past couple of decades.
Lax safety standards and FDA oversight at plants in those two countries have allowed these drugs – and likely countless more we don’t know about – to become contaminated and endanger patients. China and India now manufacture about 80% of the drugs consumed in the U.S. This figure understates China’s dominance because many of the active ingredients in the Indian manufactured drugs come from China. The U.S. doesn’t even manufacture vital drugs like antibiotics anymore, with the last penicillin factory closing in 2004.