Time To Open The FDA’s Black Box

Things just keep getting worse for India’s generic drug companies in America. Dr Reddy’s Laboratories, an Indian generic drug manufacturer, has withdrawn 13,560 bottles of generic Toprol, a blood pressure medicine, from the U.S. market due to solubility problems. The news comes hot on the heels of a recall just weeks ago by Wockhardt Ltd, another Indian producer, which withdrew 109,744 bottles of the same drug — and for the same reason.

In March, Dr Reddy’s recalled about 58,000 bottles of another drug, lansoprazole, due to a microbial contamination. And last May, Ranbaxy, one of the largest Indian drug firms, was found guilty in a U.S. court of seven felonies and fined $500 million for lying about quality lapses over the previous decade.

And on and on. If people buy their medicines from dubious international websites or directly from countries with weak laws and incompetent regulators, such as India, then they may be aware of the risks of buying shoddy products. But most people, including physicians, would assume the U.S. drug supply system is safe. They might even expect that every batch imported would be tested by FDA, which oversees a quarter of all imported medicines by value, with regular random samplings from the market of these products to ensure quality control.

They would be wrong.

Our drug supply system is essentially a black box overseen by FDA. It clearly is hiding some serious flaws. And there is no telling how, when, or whether FDA will fix them.

Members of the medical and scientific communities routinely report safety concerns to FDA based on clinical feedback from patients, and press for answers with little to show. Since 2012, Dr. Harry Lever, a senior cardiologist at the Cleveland clinic, has been reporting problems with motoprolol succinate (the blood pressure medicine Dr. Reddy’s, Wockhardt and others have recalled). He was finally told in a letter from FDA earlier this year that all was fine with the drug, and was shocked to learn of the second recall.

Dr. Lever now counsels his patients to avoid any Indian medicines. Better safe than sorry.

Dr. Preston Mason, a cardiological scientist at Harvard Medical School, assesses medicine quality from around the world. He found that 30 different and mostly Indian-made versions of the most popular drug in the world, atorvastatin (generic Lipitor), contained significant impurities. While the versions he bought from U.S. pharmacies worked fine, some used by U.S. patients bought over the internet (often Canadian websites sourcing drugs from India) had the same problem. He presented these findings in February at a congressional briefing, and prior to that has approached FDA with his findings. But he was rebuffed by FDA, which misinterpreted his work and publicly insulted his integrity by suggesting he contaminated his own samples. To this day, FDA officials still have not communicated directly with Dr. Mason.

It is noteworthy that the FDA welcomed the whistleblower in the Ranbaxy case. For without his evidence, FDA would not have noticed the problems with Ranbaxy’s products or been able to compel felony convictions. But maybe concerned U.S. physicians and scientists (one could even call them domestic whistleblowers) like Drs. Lever and Mason are more of an embarrassment to the FDA, and hence are ignored or undermined.