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Tainted drugs: Ex-FDA inspector warns of dangers in U.S. meds made in China, India

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The notice arrived at the home of Denise Schreck, a New Jersey woman who suffers from high blood pressure, last July. 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. The valsartan recall came as little surprise to Massoud Motamed, a former inspector with the U. 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. 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. 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. 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. If we want to drive competition and drive the price down, it comes at the cost of quality. For Motamed, the recalls tell only part of the story. He says a more systemic issue has largely gone unreported: FDA inspectors struggling to keep up with foreign drug manufacturers that may bury or hide problems in their production. Last year, the FDA inspected only one in five registered human drug manufacturing facilities abroad, according to agency data. With U. The FDA also inspected only about one in five domestic drug manufacturing facilities last year, according to agency data. But unlike inspections at U. That happens — no issue,' Motamed said. I've had inspections where I really could have benefited from the extra time and I knew there were problems to be uncovered, but I had to leave the country. Motamed spent three years as an FDA investigator, working mainly overseas to inspect foreign manufacturing facilities. A Texas native with a Ph. He had been in the role for more than two years when he went to inspect the Zhejiang Huahai Pharmaceutical plant in Linhai, China — the company that produced the tainted ingredients in Schreck's recalled medication — in May Motamed's four-day inspection turned up a series of alarming issues that he later outlined in official reports. Facilities and equipment not maintained. Anomalies in testing not investigated. And 'unknown impurities' dismissed as laboratory error. After his visit, and as first reported by Bloomberg , Motamed recommended that a warning letter be sent to the firm — an official action that bars the company from gaining the approvals to produce new U. But three months later, he was overruled by FDA management. The FDA decided to allow Zhejiang Huahai to voluntarily fix the problems on its own, the agency wrote in an official document obtained by NBC News, citing the firm's compliance history and mostly 'adequate responses' to impurities in their testing. After facing criticism over its handling of the case, the FDA said it would have been 'unlikely' to catch the impurities at the source of the recall during a routine inspection. In a statement to NBC News, Zhejiang Huahai said it's 'working closely with regulators here and abroad to evaluate the source of the impurities that resulted in the recall' and is determining if 'any modifications to its manufacturing processes are necessary. The problems were not confined to the facility in China. While investigating a drug production factory in India, Hetero Labs Limited, in December , Motamed discovered what appeared to be a brazen attempt to cover up issues at the plant. And that's not generally typical,' Motamed said. He decided to review the firm's closed circuit TV footage. What the inspector saw next shocked him. Motamed watched footage of individuals shredding company documents four days before his arrival, the inspection report says. It means there are systemic issues. The FDA eventually sent a warning letter to Hetero in August , citing 'significant violations of current good manufacturing practice. In the case of valsartan products, the FDA said last August that more than half of all the medication sold in the U. While it's unknown exactly how many people have been impacted by the recalls, the sheer demand for the drugs suggest it could reach into the millions. In , 1. Department of Health and Human Services. The recalls create a vexing challenge for consumers like Don Grybb, who said he struggled to find a suitable alternative after finding out that his valsartan medication was being pulled from store shelves. The FDA and outside healthcare professionals have warned consumers against suddenly stopping their medication due to the recall, saying that the short-term risks outweigh the potential impact of consuming the recalled medication. You don't want to feel like you are prescribing something that causes harm. The FDA says the overall risk posed by the impurities is small. For valsartan, FDA testing found the pills contained somewhere between three and times the agency's acceptable level for NDMA, the probable carcinogen at the center of the recall. If 8, people took the highest dose of the contaminated drug daily for four years, the FDA estimates, there may be one additional case of cancer over the lifetimes of those people. Experts said the contaminants are still powerful at low levels. The FDA has issued a list of medications free of the probable carcinogens and says it has been working to mitigate and prevent shortages. Dozens of consumers have now gathered to sue nearly every company involved in the recall through a consolidated multidistrict litigation case in New Jersey. The Association for Accessible Medicines, the trade group for generic drug manufacturers, said its 'member companies with affected products voluntarily recalled their medicines containing valsartan and have worked closely' with the FDA. Motamed left the FDA in , disillusioned over his experience trying to police a sprawling industry in what he described as a 'cat and mouse' game where companies do what they can to conceal problems from the FDA. He believes the agency needs to hire more qualified investigators and needs to conduct more inspections of the overseas facilities producing drug ingredients. Now working for the private pharmaceutical sector in India, Motamed said he's speaking out to raise awareness about the risk of tainted drugs. As for Schreck, the anxiety brought on by the valsartan recalls has prompted her to stash her bottle of pills in a small brown cabinet above her kitchen sink. She sees it as evidence that could be used in a court of law in the event that cancer were to infect her body one day. IE 11 is not supported. For an optimal experience visit our site on another browser. Skip to Content. NBC News Logo. Search Search. Profile My News Sign Out. Sign In Create your free profile. Sections U. Follow NBC News. Get more news Live on.

Tianjin buying Ecstasy