Massoud Motamed says the FDA struggles to police the sprawling number of overseas drug manufacturers who may hide problems in their production lines.
The notice arrived at the home of Denise Schreck, a New Jersey woman who suffers from high blood pressure, last July.
“URGENT PRODUCT RECALL,” blared the words at the top of the letter from her pharmacy.
The blood pressure medication used by Schreck and millions of other Americans was tainted. The culprit? A chemical with the potential to cause cancer.
Schreck went online to learn more and discovered that the generic drug, valsartan, was in fact found to contain a contaminant formerly used in the production of rocket fuel, according to a government fact sheet.
“I was just really blown away,” Schreck, 51, told NBC News. “It’s shocking to know that you’ve been taking a probable carcinogen for four years.”
The valsartan recall came as little surprise to Massoud Motamed, a former inspector with the U.S. Food and Drug Administration (FDA). More than a year before the notices went out, Motamed had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China and India that produce the active ingredients in generic valsartan and other blood pressure medications.
Speaking out publicly for the first time, Motamed told NBC News that the FDA ultimately overruled his recommendation to crack down on one of the plants. Perhaps more alarming, he says the issues at the two overseas drug production facilities are hardly unique.
“This is only the tip of the iceberg,” Motamed said in an exclusive interview.
The valsartan case underscores a new reality in the pharmaceutical industry — a growing reliance on foreign manufacturers to provide the raw ingredients for drugs sold in the U.S. According to FDA data, roughly 85 percent of the facilities manufacturing the ingredients in American drugs are located overseas, many from China and India where production costs are low and experts say local government oversight is less stringent.
The shift has contributed to a flood of recent recalls and fueled escalating concerns about the safety of medicines consumed in the U.S.
Since last summer, drug companies have announced a total of 45 recalls of generic lifesaving blood pressure medications. They include certain versions of valsartan and two other blood pressure drugs, losartan and irbesartan, as well as other blood pressure medications that contain the recalled drugs in their formulations. The raw ingredients were all traced to overseas manufacturing sites where drugs can be processed at a lower cost than at U.S. facilities.
“Growing up, we had this saying, ‘You get what you pay for,'” Motamed said. “We have that belief for everything except pharmaceuticals. If we want to drive competition and drive the price down, it comes at the cost of quality.”