WASHINGTON DC (August 7, 2019) — Senate Finance Committee Chairman Charles "Chuck" Grassley sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless urging them to reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries in light of the administration’s new “Safe Importation Action Plan” as well as the fact that these facilities provide most of the ingredients for production inside the United States. Therefore, it’s important to determine more accurately if these facilities meet set standards of quality and safety for both domestic and importation purposes.
“Unbeknownst to many consumers… 80 percent of Active Pharmaceutical Ingredients are produced abroad, the majority in China and India; however, the FDA only inspected one in five registered human drug manufacturing facilities abroad last year,” Sen Grassley wrote.
“I strongly encourage the administration’s demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine whether they meet the required Active Pharmaceutical Ingredients and drug quality and safety standards to include sufficient record-keeping, testing and protections against counterfeiting.”
This letter comes after a previous letter on the topic sent to Azar and Sharpless in June. In that letter, Sen Grassley sought information on the quality controls for prescription drugs and their components manufactured in foreign countries, specifically China and India. The letter also asked what the FDA is doing to uphold safety standards in the United States, China and India via inspections of manufacturing facilities. Reports have noted that 80 percent of active pharmaceutical ingredients are produced in China and India and that facilities in those countries have not maintained adequate quality control standards.
Text of the letter is available HERE.