Although the massive valsartan impurities recall took the industry by storm, some argue that it was only a symptom of a much larger problem.

In July 2018, the U.S. Food and Drug Administration (FDA) announced the recall of several valsartan medications due to concerns that the drugs were contaminated with N-nitrosodimethylamine (NDMA). NDMA is a naturally occurring substance that may be found in certain foods that have been cooked, smoked or cured.

NDMA has been classified as a probable human carcinogen, meaning it is suspected to cause cancer based on the results of laboratory tests.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb said when the recall was announced.

“As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

In the months that followed the recall announcement, countless manufacturers added their own products to the list of recalled valsartan tablets. Other blood pressure medications were added to the recall, and the issue was eventually traced to several foreign facilities that manufactured the active ingredients for the drugs.

Former FDA inspector Massoud Motamed told NBC that he was not surprised by the massive valsartan recalls based on his own experience with foreign facilities.

More than a year before the valsartan notices went out to the public, Motamed reportedly flagged potential problems in two active ingredient facilities in China and India, both of which manufactured ingredients used in generic valsartan. But Motamed’s concerns were not followed up on.

“Say I’m at a domestic facility and I tell my supervisors that I’m finding all these problems and I need more time to inspect. That happens — no issue,” Motamed said in his interview with NBC. “The same is not true of a foreign facility. I’ve had inspections where I really could have benefited from the extra time and I knew there were problems to be uncovered, but I had to leave the country.”

Unfortunately, Motamed says that due to time constraints and his decisions being overruled, the two labs were allegedly allowed to continue without regulatory action. Later, the Zhejiang Huahai Pharmaceutical plant in China and the Hetero Labs Limited facilities in India were both found to be sources of the contaminated active ingredients leading to valsartan impurities.

“This is only the tip of the iceberg,” Motamed told NBC.

With so many products being recalled due to valsartan impurities, the country has faced a shortage of many angiotensin II receptor blocker medications used to treat high blood pressure.

In response to this, FDA Commissioner Gottlieb announced in March that the agency would be prioritizing applications for new generic valsartan products. By approving more medications, the FDA hopes to mitigate some of the shortages caused by the past year’s massive recalls.

In light of growing concern over valsartan recalls, the FDA is also going to widen its investigation into drug impurities. Reuters reports that the FDA has been investigating impurities in U.S. generic drugs, but until now, that investigation has been limited to angiotensin II receptor blockers — a class of high blood pressure medications.  

Reuters explains that the FDA has not revealed what drugs will be included in the expanded investigation. However, the FDA reportedly did say that impurity testing was underway.

According to Reuters, the testing will examine the possible connection between impurities and manufacturing processes — testing will be done on medications that are produced in manufacturing processes similar to those used to produce medications that have already allegedly been contaminated.

The FDA’s director for the Center for Drug Evaluation and Research said, “now that we know some of the root causes of the nitrosamine impurity problem, we’re using these findings to inform our evaluation of medicines other than ARBs,” according to the Regulatory Affairs Professionals Society. 

However, this matter could be difficult for the public to fully understand, because many drug companies have secret manufacturing processes.

According to the Regulatory Affairs Professionals Society, the FDA is also working with foreign organizations, including the European Medicines Agency and Health Canada, to better understand the contamination problem around the world.

The Regulatory Affairs Professionals Society says that the FDA is attempting to not only identify the contamination problem through testing, but to lessen the impact of such contaminations by implementing changes to its approval application program and inspection processes.