At Lever’s urging, Farrell called 10 different pharmacies nearby and found one that sold torsemide made by Israel-based Teva, which has factories all over the world, including in India, Hungary, China and the U.S. (It’s unclear where Farrell’s new medication was made.) Despite changing medication, he never fully recovered, dying in September at age 67, about a month after celebrating his 40th wedding anniversary.
There’s no proof the Indian-made torsemide was ineffective and led to his death. But his physician is now more concerned than ever. Lever thought it was bad enough when quality issues appeared to be an overseas problem. He was shocked to learn companies in the U.S. have been caught with data integrity problems as well.
“I’ve been smelling rats,” Lever said. “I didn’t realize there were that many.”
Camber confirmed in an email that Hetero’s torsemide is made in India and said the plant that makes the drug was inspected in the last six months and the FDA didn’t find any violations.
“Hetero and Camber manufacture and distribute almost 100 million torsemide tablets per year (a billion since its approval in January 2009) and a quick review of our records shows a total of three complaints in the last year,” said Kirk Hessels, a spokesman for Camber.
Indian companies accounted for 38 percent of approvals in 2018 through October 30, up from 33 percent in 2015, according to senior Moody’s analyst Morris Borenstein. Over the same period, Chinese drugmakers accounted for 8 percent of approvals, up from 1 percent, Borenstein said.
These numbers don’t include companies in India and China where active ingredients for drugs are made, because most drugmakers keep secret where they buy such key building blocks. At least 80 percent of active ingredients used to make U.S.-consumed drugs are produced outside of the country, according to the FDA. In the rare instance an active ingredient’s origin does become public, it’s typically because of a serious recall, as in the case of valsartan.
The FDA has come a long way since the heparin crisis of 2008, when Congress went after the agency for not knowing how many foreign facilities were even making drugs for Americans to take.
“I think our oversight is better than it’s ever been,” said Janet Woodcock, director of the FDA center responsible for overseeing new drug approvals who has served at the agency in various capacities since 1986. “That’s my professional judgment of manufacturing worldwide. We know where they are, we know who they are, we know what they’re making, we know when we’ve been there, we know who else has been there. Could we improve? Yes, but I wouldn’t look at absolute stark numbers and say that should be a greater or lesser cause for concern.”
Woodcock pointed to an agreement with the FDA’s counterparts in the European Union as one of the reasons that surveillance inspections could be going down. The deal lets the FDA rely on EU inspections in European countries instead of duplicating the work. But the deal took effect only in November 2017, after the surveillance numbers started falling, and the agreement doesn't cover India or China.