Generic Drug Safety Concerns Refuted By FDA Amid Continuing Valsartan Recall Problems

In response to growing concerns about the safety of generic drugs, which emerged following recent valsartan recalls issued over cancer-causing impurities, federal regulators are defending their oversight and monitoring of generic manufacturers.

In a statement issued by the U.S. Food and Drug Administration’s (FDA) on February 22, Commissioner Scott Gottlieb, M.D. and Janet Woodcock, M.D., who is director of the agency’s Center for Evaluation and Research Director, outlined continuing efforts to maintain what they describe as “strong oversight” of generic drug quality issues, both domestically and abroad.

The agency is refuting recent reports in the press that call into question the safety of the U.S. generic drug supply. The reports have emerged since problems with generic valsartan surfaced last year, involving a Chinese manufacturer who distributed pharmaceutical ingredients for years that contained carcinogenic chemicals that may be a byproduct of the manufacturing process.

Woodcock and Gottlieb indicate that the same vigorous FDA processes are used for approval and verification of brand-name drugs and generic medications. Not only are all drugs tested to meet requirements, Woodcock indicates that the facilities and manufacturing plants in which generic drugs are also inspected to ensure compliance with the agency’s good manufacturing standards.

Once a drug has undergone the vigorous testing and approval process for market use, manufacturers both abroad and domestic are required to notify the FDA of any changes made during the manufacturing process no matter how insignificant, according to the statement. However, consumer confidence in the safety of generic drugs has been shaken by recent discoveries that some foreign manufacturers may have changed processes to increase yield, and FDA oversight failed to detect the problems for years.

Within a few years of the approval of generic valsartan and valsartan HCTZ drugs, which were designed to copy brand-name Diovan, recent reports have suggested that much of the nation’s supply of the bloodpressure drug was tainted with nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which are impurities known to increase the risk of cancer among humans.

The first concerns about the risk that valsartan pills containing impurities that increase the risk of cancer surfaced in July 2018, when European regulators announced that batches of the active ingredient supplied by China-based Zhejiang Huahai Pharmaceuticals tested positive for the known carcinogen NDMA. Shortly after, the FDA followed with its valsartan recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

Recent reports suggest that the valsartan impurity problems may have resulted from changes to the generic drug manufacturing process, which were designed to synthesize more of the pharmaceutical ingredients and increase profits. Similar problems have not been linked to the manufacture of name-brand Diovan pills.

The chemical impurities may increase the risk of digestive tract cancers following long-term exposure, including liver cancer, kidney cancer, bladder cancer and stomach cancer.

The FDA’s investigation into the valsartan recalls is still ongoing, and the agency has indicated that the first appearance of the chemical impurities were detected in drugs distributed since 2014. Preliminary findings of the drug sales across the U.S. have estimated more than 60 million American patients could have received these drugs from pharmacies, not including those who would have received the drug from hospitals or the VA systems.

A growing number of valsartan lawsuits are now being filed on behalf of individuals diagnosed with cancer, and class action lawsuits are being pursued to obtain medical monitoring funds for individuals who were exposed to the carcinogenic chemicals in their generic blood pressure drugs.