Walden, E&C Committee members request FDA briefing on coronavirus impacts

U.S. Rep. Greg Walden (R-OR), ranking member of the U.S. House Energy and Commerce (E&C) Committee, led a bipartisan group of committee members in seeking a federal briefing related to the current coronavirus COVID-19 outbreak.

Specifically, the lawmakers want information on what impact COVID-19 could have on the nation’s supply of drugs and other medical products, according to a March 9 letter Rep. Walden and his colleagues sent to U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn.

“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,” wrote Rep. Walden and the committee members.

Rep. Walden and the other lawmakers also want to know what impact the virus might have on Chinese-manufactured medical products, including personal protective equipment, such as surgical masks, gowns and gloves.

“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,” according to their letter. “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.”

Among other items, Rep. Walden and his colleagues also requested 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.

“FDA has the authority and responsibility to ensure that these products remain safe, effective and available for American healthcare workers and patients,” the members wrote. “The world is counting on our public health agencies to respond quickly and effectively to address this outbreak.”

Among the E&C Committee members who signed the letter are U.S. Rep. Frank Pallone (D-NJ), committee chairman, and U.S. Rep. Michael Burgess (R-TX).