Recently, a small, privately-owned and operated lab in Connecticut discovered “high levels” of a carcinogenic chemical in batches of ranitidine (Zantac). It was not just contamination from an outside source. Scientists at the Valisure determined that the problem was inherent in the molecule itself. They notified the FDA immediately, which in turn issued a public alert – but that warning was lukewarm at best.
The notification stated that “some products commonly known as the brand-name Zantac” had been contaminated with an industrial byproduct known as NDMA “at low levels.” Furthermore, the FDA did not advise patients to stop taking it, nor did it demand an immediate recall, although some drug companies recalled their ranitidine products “voluntarily.”
What gives here? Isn’t it the job of the FDA to protect the public from adulterated and dangerous products? And why did the agency minimize the danger after it was notified about the contamination? Other agencies around the world certainly took action.
In Singapore, national health authorities immediately removed eight brands of ranitidine from pharmacies. Similar actions were carried out in Canada, South Korea, and India. Upon learning about the situation, several drug companies in the U.S and elsewhere – including GlaxoSmithKline, the original manufacturer of Zantac – stopped distribution, as have several U.S. pharmacies.
It took the FDA almost six weeks to announce that it discovered “higher than acceptable” levels of NDMA in the samples they had tested – and then asked drug companies to please recall some of their stock. It was not mandatory. Compliance was “voluntary.” In response to criticism of the FDA’s weak response, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, simply said, “Do we have to do exactly what others do? We did the testing, and in some we found hardly any. Should they be pulled off the shelves?”
Why not, Dr. Woodcock? That’s what other countries and drug companies have done.
The fact appears to be that the FDA has been slacking off in recent years. According to the Government Accountability Office, FDA inspections of foreign pharmaceutical facilities went down by 10 percent between January 2016 and the end of 2018. Inspections of U.S. plants declined by 13 percent. Unfortunately, the FDA’s authority is limited when it comes to getting potentially dangerous medications out of patients’ hands and off of pharmacy shelves.
According to U.S. Representative Rosa DeLauro (D-CT3), the FDA has no real desire to expand its power in such areas. In a statement to Bloomberg, Representative DeLauro said, “It has been my experience over the years that the FDA shies away from its responsibility as a regulatory agency.”
The FDA can order recalls of infant formulas, medical devices, tobacco products, and vaccines as well as opioid-based medications. That’s where the agency’s power ends, however. It cannot force recalls of any other prescription drugs. In 2017, Rep. DeLauro sponsored a bill that would have expanded FDA authority to order recalls, but the drug industry lobby made certain that the bill never saw the light of day.
A spokesperson for the Pharmaceutical Researcher and Manufacturers of America (PhRMA) insists that the industry and the FDA already “work together throughout the recall process to protect the public health,” and that “Additional mandatory recall authority is not needed.”
In light of similar discoveries made about common blood pressure medications and at least one antidepressant, Rep. DeLauro is making another attempt to expand FDA recall – but she can expect considerable resistance from PhRMA, and very little (if any) support from the FDA itself.