Concerns about valsartan contamination and impurities found in other blood pressure drugs have driven a congressional panel to demand answers from the FDA.

On Feb. 13, the U.S. House Committee on Energy and Commerce sent a letter to FDA commissioner Scott Gottlieb, asking him for a meeting to discuss the agency’s inspection of overseas pharmaceutical facilities. The letter follows a slew of recalls of foreign-made blood pressure medications like valsartan after it was discovered they could be contaminated with carcinogens.

The representatives note that even following more than a dozen recalls, the FDA still has a backlog of around 400 foreign manufacturing facilities waiting to be inspected. The FDA has been authorized to inspect foreign pharmaceutical plants and firms since 2012, with the guidance that they were supposed to prioritize ones that had not been recently inspected.

Cancer Risk from Valsartan Contamination

Concerns about valsartan contamination, according to legislators asking questions, are just the tip of the iceberg when it comes to concerns about pharmaceutical plants and the FDA’s ability to review these key details.

A total of 15 recalls of blood pressure medicines made in China and India have been issued in the last seven months. These recalls occurred because the blood pressure drugs made in foreign countries potentially contained carcinogens such as NDEA and NDMA.

July 2018 was the first time that the FDA announced recalls of valsartan blood pressure medications after testing identified an impurity of NDMA in tablets that were manufactured by Zhejiang Huahai Pharmaceuticals.

More products were added to the recall list at the end of 2018, including 104 lots of combination tablets with amlodipine and valsartan, combination tablets with hydrochlorothiazide and valsartan, in valsartan tablets.

The FDA says it found multiple manufacturing violations at Zhejiang Huahai Pharmaceutical’s Chuannan facility, including problems with change control, cross contamination and impurity control. The agency says it is still investigating the root cause of the impurity, which has affected numerous lots of blood pressure medication that contain valsartan.

Factories must maintain proper protocol when producing drugs, regardless of whether they are located in or out of U.S. borders. FDA inspections are supposed to be a system designed to flag locations with problems before contamination occurs.

So far, research has shown that the risk of getting cancer from the contamination is relatively low. However, many people rely on blood pressure medications containing valsartan, and could have been continuously exposing themselves to the risk. The risk is still concerning enough for the drugs to have been pulled off pharmacy shelves.

At least one valsartan lawsuit has already been filed against the pharmaceutical company running the plants in which the contamination issues were uncovered. Other lawsuits have already targeted manufacturers of recalled drugs, including one case that alleges that some lab employees were caught on video shredding documents before a 2016 FDA inspection.

These claims suggest that the companies knew there were problems in their plants, but that the manufacturers failed to take actions to correct these concerns or to allow for an honest inspection of their facilities.

Though the risk posed by valsartan contamination is reportedly small, some people could still be at risk from using these contaminated medicines over a long period of time. The FDA advises not to discontinue any medications without checking with their physician first. Patients are encouraged to monitor for any unexplained side effects and continue to attend regular cancer screenings.