WASHINGTON (Legal Newsline) - A small vendor of Xray dye is facing near-certain extinction if Congress goes through with a proposal to reclassify medical contrast agents as drugs rather than as devices.
St. Louis-based Genus Medical Technologies, which manufactures barium sulfate, sued the Federal Drug Administration (FDA) over categorization in 2019 and won, according to a report in pharma industry observer Pink Sheet.
“There’s zero public benefit to this anti-competitive kill shot and zero justifications have been offered as to why FDA and the House Committee on Energy and Commerce are suddenly so motivated to defy the court,” said Ed Powers, CEO of Genus Medical.
The E&C committee is scheduled to revise H.R. 7667 this week during a markup session on May 11, according to the committee’s website.
“Since this provision would do irreparable harm to our company and reduce patient access when contrast media is in short supply, we are wondering why the E&C brass would fast-track this without going through regular order,” Powers told Legal Newsline.
According to Powers, if contrasting dye is reclassified, companies like Genus won't be able to afford the FDA filing and maintenance fees, along with other costs that are required for drug applications. He said that costs would far exceed the amount of profit to be made.
“While one large competitor may be able to afford the fees if they monopolize the entire market, small competitors are squeezed out," Powers said.
“For Genus, this means we would likely exit the market and either close or downsize, with U.S. manufacturing and other job losses across our business. For the American healthcare patient, it means higher prices, restricted product access, lack of innovation, and 100% dependence on foreign supply for yet even more of our healthcare product needs.”
The Chinese government’s Shanghai shut down due to COVID-19 has caused a shortage of the liquid dye in the U.S., according to a major hospital system.
“Due to unprecedented COVID-related supply chain disruptions in China, all hospitals in the United States are experiencing a shortage of contrast media (sometimes referred to as X-ray dye) used to perform CAT or CT scans,” St. Luke’s University Health Network in Pennsylvania said in a statement online. “As at all U.S. hospitals, St. Luke’s ability to perform these scans in all but the most critical cases will be limited until these supply chain issues are corrected.”
Shanghai is where most of the world’s supply of medical dye is produced and subsequently distributed by GE Healthcare and Italy-based Bracco.
Bracco wholly owns Blue Earth Diagnostics, which is a client of former House Committee on Energy and Commerce senior staff director turned-lobbyist, Jeff Carroll.
"Many are struggling to understand how a small American company is being railroaded by FDA and E&C at the behest of a foreign behemoth who is seemingly allergic to competition,” Powers added.
Carroll did not respond to requests for comment.
As previously reported in Legal Newsline, Carroll registered as a lobbyist in the fourth quarter of 2021 and the first quarter of 2022 after having left the office of Rep. Frank Pallone (D-NJ) in July 2021 and joining Capitol Counsel, in spite of ethics rules that require a one-year wait period between government service and lobbying.
The Washington Free Beacon reported May 6 that Capitol Counsel is allegedly involved in a network of D.C.-based organizations that are working on behalf of the Chinese Communist Party (CCP).
"It’s really murky and pretty gross," Dylan Hedtler–Gaudette, government affairs manager at the Project on Government Oversight, told the Washington Free Beacon.
The report quotes Hedtler-Gaudette saying that overlapping ties between Capitol Counsel, the Exchange Foundation, and the Association of Former Members of Congress constitute a "shadow lobbying operation."
"The arrangement shows the extent of the Chinese Communist Party’s propaganda operation in the United States," the report states. "It also highlights a type of influence peddling prevalent in Washington, where consulting firms work with think tanks and nonprofit organizations on behalf of corporate clients and foreign entities, often without disclosing the connections."