Sen. Chuck Grassley (R-Iowa) said at a Senate hearing on Tuesday that the COVID-19 pandemic has demonstrated a need for a “robust and aggressive” inspection program for medications manufactured in foreign countries.
Grassley noted that the U.S. imports 19% of its active pharmaceutical ingredients (API) from India and 13% from China. He noted that over 70% of API-manufacturing facilities are located outside of the U.S.
“These figures coupled with the COVID pandemic have got a lot of attention, including what might need to be done from a national security standpoint,” he said. He added that over half of manufacturing units which convert APIs to medications are also located outside of the U.S.
“But, the figures do make clear what needs to be done from a drug safety perspective – we need to have a robust and aggressive foreign inspections program,” he said.
Grassley mentioned valsartan as an example of a drug made in China and India which has had serious quality control issues. Valsartan has been found to contain carcinogenic contaminants which are found in rocket fuel. The drug has been found to be contaminated with NDEA, which the World Health Organization classifies as a Group 2A carcinogen, and NDMA, which is classified by the U.S. Environmental Protection Agency as a probable carcinogen.
“Facilities in China and India produce that drug,” Grassley said.
Senators have criticized the FDA’s foreign drug inspection program because it provides foreign manufacturers with prior notice of an inspection. They asked the FDA to “level the playing field” by performing more unannounced inspections of foreign drug manufacturers as deception prevention.
FDA associate commissioner for regulatory affairs Judith McMeekin said that while most foreign inspections are pre-announced, this is important because it helps verify that foreign manufacturers fall within FDA jurisdiction and that records and personnel are maintained. She added that FDA inspectional authority doesn’t apply abroad and that pre-announcement helps the FDA get permission for inspections.
The FDA’s routine foreign inspections have been indefinitely suspended because of the COVID-19 pandemic. The agency is, however, taking measures to make sure drugs manufactured abroad are safe and high-quality.
The Senate was told these measures include checking compliance history of foreign manufacturers, increasing physical checks at the U.S. border, cooperating with foreign governments to ensure mutual quality control, denying entry to medications which do not meet standards and requesting documents from manufacturers in place of or in advance of on-site drug inspections.