More than 8 million U.S. patients take 80-320 milligrams of the popular generic hypertension drug valsartan each day, many for years at a time. But last year, the FDA announced voluntary recalls of numerous valsartan supplies that contained a cancer-causing impurity, N-nitrosodimethylamine, or NDMA.
Valsartan supplies made in China and India could have contained NDMA since as far back as 2012. Just how dangerous is NDMA? In 1978, a German teacher got life in prison from putting NDMA in his wife’s jam. That same year, a Nebraska man got the death sentence for spiking lemonade with NDMA, killing his ex-girlfriend’s new husband and her 11-month old nephew.
In 2013, a Chinese medical student died after his roommate put NDMA in the water cooler as an April Fool’s prank. In 2018, a Canadian graduate student used it to poison a post-doctoral fellow’s apple pie at Queen’s University.
In the lab, NDMA is used to cause cancer in rodents for oncology studies. The FDA says consuming anything over 0.001 milligrams per day is potentially toxic to humans. One contaminated valsartan pill contains as much as 0.020 milligrams of NDMA – nearly 20 times greater than levels considered safe to consume.
The question is, how did such a deadly pill get into the hands of U.S. consumers? Don’t our tax dollars pay the FDA to protect against that sort of thing?
Yes, the FDA’s job is to scrutinize our medications for safety and efficacy. But the reality is, they aren’t doing their job - repeatedly allowing overseas generic drug manufacturers to get away with unacceptable laboratory conditions and slack manufacturing practices.
Case in point: In 1996, Swiss pharma giant Novartis put its new blood-pressure medication Diovan on the market. It would become the top hypertension medication worldwide.
In 2012, the U.S. patent on Diovan expired. Generic drug companies like China’s Zhejiang Huahai Pharmaceutical Co. start producing valsartan, the generic form of Diovan, to export into the U.S. To reduce costs, Huahai decides to use a different solvent than Novartis in making the drug.
Five years later, an FDA inspection of Huahai finds the company has been ignoring test results showing an impurity is present in their valsartan preparations. The inspector recommends that the FDA send Huahai a warning letter, which could have stopped Huahai from making any more valsartan until it could pass inspection. But instead of a warning letter, the FDA managers said Huahai had passed previous inspections, and the valsartan still worked, so it's all good.
Neither the FDA nor Huahai tries to identify the contaminant.
Nothing happens until May 2018, when Novartis ordered some of Huahai’s valsartan product to make its own generic drugs. Novartis saw the impurity, tested it, and identified it as NDMA. In July, the FDA announced voluntary recalls of valsartan made at Huahai and several Indian labs (who had also been using the cheap solvent from the Huahai protocol).
Finally, in September 2018, the FDA finally stops one Huahai facility from exporting its products into the U.S. At the time, Reuters announced that more than 50 companies around the world recalled contaminated valsartan products. Huahai gets an FDA warning letter saying they should have identified the contaminant earlier and considered it could have been toxic.
Meanwhile, U.S. patients have been taking NDMA-contaminated valsartan pills for six years. European health regulators estimate that one out of 3,390 people could develop cancer from taking these drugs. Lawyers are receiving hundreds of claims that patients who took valsartan between 2015 and 2018 developed cancer of the stomach, liver, colon, small intestine, esophagus, and kidney.
Can the FDA really blame Huahai? FDA spotted the problem back in 2017, and as far as Huahai was concerned, FDA was fine with an unidentified impurity.
China and India make at least 80% of U.S. generic drug active ingredients. Yet, the FDA tests less than 1% of foreign-made drugs for impurities before approving export into the U.S. FDA says they simply aren’t equipped to monitor every overseas manufacturing facility. When they can conduct an inspection, they can’t follow up to ensure faulty facilities are correcting substandard performance.
An obvious solution would be to prohibit export from the facilities that can’t be inspected fully and properly. Instead, the FDA asks these foreign drug makers to police themselves, trusting them to make their own corrections.
So when a Chinese drug company can save millions by using cheap solvents and ignoring contaminants, they’re supposed to give up those millions for the safety of the American consumer -- not going to happen.
Huahai can blame the FDA. The FDA can blame Huahai. Meanwhile, no one is held accountable and, patients are dying.
Another potential solution would be for U.S. pharmacies to start testing the drugs they sell for purity and potency. Some are already doing so. But while we wait for a fix that works, we always have the False Claims Act (FCA).
Under the FCA, the government pays large cash whistleblower awards to anyone with inside knowledge of poor manufacturing procedures or FDA cGMP violations. Overseas or domestic lab technicians, drug company executives, drug sales representatives, pharmacists, and others with information regarding improper manufacturing, fraudulent record-keeping, or other forms of pharmaceutical fraud are eligible for FCA whistleblower awards.
If you suspect your pharmaceutical employer or other company is participating in drug manufacturing violations or other pharmaceutical fraud, contact us confidentially by emailing us at: [hidden email] or call us at 202.780.9957.
We connect potential whistleblowers with the necessary experts and qualified lawyers required to maximize cash awards and protection from retaliation. There is no fee for our services. The Pharmaceutical Integrity Coalition (PIC) is an independent Advocacy Group with no ties to the Pharma industry.