Data integrity was also at the heart of FDA inspector concerns at a plant halfway across the world, where Zhejiang Huahai Pharmaceutical Co. Ltd. was supplying the active ingredient valsartan—a widely used treatment for high blood pressure that is taken alone, as well as sold in combination with other cardiovascular drugs—for major pharmaceutical companies such as Teva Pharmaceutical Industries Ltd., the largest generic drug maker in the world.
The inspection in May 2017 found that the Chinese ingredient maker ignored quality checks that showed unnamed drugs didn’t meet U.S. standards. Four months later, higher-ups at the FDA once again overrode the concerns of those on the ground who wanted to slap Zhejiang Huahai with harsher penalties. Instead, the agency gave the company a chance to fix its problems.
Jun Du, chief executive officer of Zhejiang Huahai subsidiary Prinston Pharmaceutical Inc., said it has been in close contact with the FDA about valsartan and has “collaborated throughout with agency staff, our customers and patients.” Prinston used its parent company’s active ingredient to make its valsartan, which has been recalled.
More than a year after the inspection, numerous drug companies recalled valsartan, including Teva, for containing a probable cancer-causing chemical. Teva has since stopped selling the drug.
“I’ve been smelling rats. I didn’t realize there were that many.”
The FDA says the U.S. has the safest drug supply in the world. But even anecdotal cases of such problems undermine a core assumption about the practice of medicine: that the drugs a doctor prescribes are safe and effective. Even an inkling of doubt about a drug’s quality makes a physician's job that much harder.
Harry Lever, a cardiologist at the Cleveland Clinic in Ohio, has been particularly wary of drugs made in India and China for several years. As a physician, he often has no control over which generic drugmaker is used to fill a prescription. Many times, when he has a patient who isn’t improving or whose condition has worsened, he asks them where their drugs are made.
One of those patients, Dick Farrell, had open-heart surgery in 2015 and had been doing well until last year. The former reporter and editor from Dover, Ohio, started having trouble with simple tasks like walking from the parking lot to the grocery store. He was admitted to the Cleveland Clinic in April with congestive heart failure. Soon after, Lever asked him to check whether his diuretic, called torsemide, was made in India.
It was. Farrell had been taking torsemide made by Hikma Pharmaceuticals Plc, a London-based drugmaker, and was switched by his pharmacy benefit manager to the Camber Pharmaceuticals Inc. version of torsemide in either late 2017 or early 2018. Closely held Camber repackages drugs made by Indian drugmaker Hetero Labs Ltd., which was warned by the FDA in 2017 for failing to adequately investigate test results that showed products didn’t meet U.S. standards and for not properly cleaning and maintaining equipment.
The FDA’s warning to Hetero doesn’t identify specific drugs because the agency typically redacts drug names to protect trade secrets and can’t reveal where a drug is made, except under special circumstances.