Bipartisan Energy and Commerce Committee leaders wrote to Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D. asking a series of questions and requesting a briefing on the potential impact the novel coronavirus (COVID-19) could have on the supply of safe drugs and other medical products in the United States.
The letter was signed by Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY).
“As FDA and our other health agencies respond to this global emergency, we want to ensure that FDA is equipped to maintain its commitment to protecting and promoting public health by addressing potential shortages and minimizing harm for patients," the bipartisan Committee leaders wrote to Commissioner Hahn.
During a Health Subcommittee hearing in December, Dr. Janet Woodcock, FDA’s Director of the Center for Drug Evaluation and Research, noted that drug manufacturing, particularly manufacturing of active pharmaceutical ingredients (API), has moved overseas in recent years, with 13 percent of API manufacturing facilities now located in China. FDA has reported that at least one human drug has already been added to the Agency’s drug shortage list following an API manufacturing site being affected by the COVID-19 outbreak.
The members also noted in their letter that other medical products, including personal protective equipment (PPE), such as surgical masks, gowns and gloves, are also manufactured in China, and may be impacted by the outbreak.
“To better understand FDA’s efforts to mitigate supply chain problems, we ask that you provide Committee staff a briefing regarding these challenges. Specifically, we would like to know how many manufacturers, distributors, and importers might be affected by supply chain issues as a result of the COVID-19 outbreak. We are also interested in FDA’s ongoing work to combat shortages, including what the Agency is hearing from potentially affected manufacturers, distributors, and importers, and what steps it is currently considering or taking to reduce potential shortages," the members continued.
The members also requested, among other things, information on how many alternatives are available for the human drug added to the shortage list, how FDA intends to handle notifications of drug and medical supply shortages, if the outbreak has impacted FDA’s risk-based inspections and whether FDA will need additional resources to meet supply chain demand.
Read the letter to FDA HERE.
