This article has been updated with comments from an attorney for Genus Medical Technologies.
A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug.
The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body. Judge James Boasberg of U.S. District Court for the District of Columbia on Friday kicked the case back to the FDA for further administrative proceedings.
Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because its barium sulfate component, whose opacity enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does.
The FDA issued a warning letter to Genus following a 2017 inspection. Genus took the matter to the FDA’s Office of Combination Products, which ruled that the product should be regulated as a drug. Genus then sued the FDA seeking to have Vanilla SilQ regulated as a device — a far less complicated and costly route than regulation as a drug.
The FDA argued that although the Vanilla SilQ products appeared to qualify as a device under the federal Food Drug and Cosmetic Act, they were also drugs and could be regulated accordingly. When a product meets the definition of both drug and device, the agency claimed it has discretion to decide into which category to place it.
Genus estimated the cost of seeking clearance to market its product as a device at $60,000, whereas seeking approval to market it as a drug could exceed $500,000, plus a continuing annual cost of more than $186,000, according to the court order dismissing the FDA’s motion for summary judgment.
Genus attorney Douglas Farquhar told MassDevice in an interview that he doubted the FDA would again try to regulate Vanilla SilQ as a drug. The company will probably file a 510(k) application to have the product cleared by the agency, he said.
The judge’s decision in this case may have implications for other medical products, added Farquhar, of the Washington, D.C. law firm of Hyman, Phelps & McNamara.
“If there are other products that meet the definition of device that FDA is regulating as a drug, then people who are marketing those products should be able to use this decision to challenge that determination,” Farquhar said.
The FDA did not immediately comment on the judge’s decision.
