Generic Valsartan Shortages Following Contamination Recalls Lead FDA To Prioritize Approval of New Drugs

Amid growing drug shortages caused by a number of valsartan recalls issued due to the presence of cancer-causing impurities, federal regulators are fast-tracking approvals for new generic versions of blood pressure medications.

On March 12, the FDA issued a press release announcing the approval of a new generic valsartan, which will help improve the drug supply in the United States for generic equivalents of the hypertension drug previously sold under the brand name Diovan.

The approval comes after a string of massive recalls impacting generic valsartan and other similar medications, which were contaminated during the manufacturing process with N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA); all of which are believed to be cancer-causing agents. The approval was granted to Alkem Laboratories Limited.

“We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” FDA Commissioner Scott Gottlieb, said in the press release. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”

Gottlieb said the agency is continuing to work with drug manufacturers to prevent the formation of impurities in valsartan products in the future and is facilitating manufacturing process changes to prevent future contamination. The latest approval involved a review of the manufacturer’s processes to ensure they do not lead to NDMA or contamination. NMBA contamination was not known of at the time.

The first concerns contaminated ARB hypertension drugs emerged in July 2018, after a number of generic valsartan recalls were issued for pills that contained ingredients supplied by Zhejiang Huahai Pharmaceuticals, of China. Since that time, the FDA has had an ongoing investigation to determine the scope of the contamination and the potential risk to consumers.

In late September, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals, after an inspection report outlined a number of serious manufacturing problems at the company’s facility in late August.

The recalls have led to a valsartan shortage and a spike in prices, with the cost of 160 milligram and 80 milligram tablets of generic valsartan more than doubling in September 2018.

As consumers nationwide continue to face concerns about the safety of pills they have taken in recent years, a number of valsartan recall class action lawsuits have been filed nationwide, seeking damages for the cost of the recalled drugs and medical monitoring. For those diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, individual cases are being reviewed by valsartan lawyers.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.