Doctors worry FDA can't ensure quality of foreign generics; 80% of active ingredients in U.S. drugs come from India or China

Adobe illustration adapted by The Boston Globe

Some U.S. doctors worry that the federal government is not doing a good job of policing generic prescription drugs -- which account for 90 percent of the prescription drugs Americans use, are overwhelmingly made in India or China, and are sometimes not effective, Katherine Eban reports for The Boston Globe, in a story headlined "These pills could kill you."

"The majority of generics bought in the U.S. are made overseas," writes Eban, author of Bottle of Lies: The Inside Story of the Generic Drug Boom. "Roughly 40 percent are manufactured in India; 80 percent of the active ingredients in all of our drugs, whether brand-name or generic, are made in India and China."

Doctors at the Cleveland Clinic are among those who have confirmed problems with Indian-made generics and complained to the Food and Drug Administration, which inspects more drug manufacturing plants in other countries than it does in the U.S.

The FDA says it has a reliable review system for generics, "but American physicians — particularly those who prescribe drugs that require precise dosing — are questioning the FDA’s ability to police overseas manufacturing," Eban reports. "Do the generic drugs that the agency approves actually meet the FDA’s standards, since the agency’s own investigators have discovered staggering fraud in a number of overseas drug plants?"

Eban's story includes examples of American patients put at risk by ineffective generics. She writes that while the FDA "has struggled to police a global drug supply, U.S. patients have faced a perfect storm of consequences. The ever-climbing prices of brand-name drugs have led to our reliance on the lowest-cost manufacturers overseas. Recently, dozens of versions of the generic blood pressure medicines — valsartan and losartan — have been recalled, due to ingredients manufactured in China that contained a carcinogen that had gone undetected for years. The U.S. makes almost none of its own antibiotics anymore."

Eban opines, "Solving these problems requires a multi-pronged solution to reduce brand-name drug prices, overhaul the FDA’s foreign inspection program, and revamp a system in which regulators rely on company-submitted data to verify drug quality. But along with these efforts must come a rethink of who makes our drugs where. Shouldn’t some percentage of our essential drugs be made on U.S. soil?"