Time To Open The FDA’s Black Box

Roger Bate Resident Scholar, AEI
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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 Dr Reddy’s Laboratories, an Indian generic drug manufacturer, has withdrawn 13,560 bottles of generic Toprol, a blood pressure medicine, from the U.S. market due to solubility problems.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.

There is no doubt that the FDA is an important agency that, broadly speaking, does a good job. But it is not omniscient, and it needs all the help it can get. The black box of drug quality needs to be opened since some Indian companies are evidently cutting corners with the drugs they send to the U.S. Others are simply not competent to make high quality drugs.

As a first step in making U.S. physicians better aware of the problems with these products, the FDA should publish all data submitted by the companies demonstrating bioequivalence (meaning that their generic drug works in the body exactly as the originator product), and publish its own independent quality assessments. That way physicians can make more informed choices about which generic they want for their patients.

Given the agency’s intransigence, it’s unlikely to take this step soon, if ever. That’s why New York State Assemblywoman Amy Paulin, a Democrat from Scarsdale, wants to bypass the FDA with a bill that would force drug companies to share bioequivalence information or be barred from New York’s drug market. This would be a welcome step in the right direction. In the mean time, physicians and patients must take responsibility for the medicines they buy. FDA simply cannot ensure all products are equally safe and effective.

Roger Bate is the author of Phake: The Deadly World of Falsified and Substandard Medicines and an adjunct scholar at the American Enterprise Institute.