A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug.
Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component 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 (FDCA), 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.
In last week’s ruling, the appeals court agreed with a lower court in ruling that the FDCA “unambiguously forecloses the FDA’s interpretation,” granting summary judgment in Genus’s favor and vacating the FDA decision to classify Genus’s products as drugs. “We agree with the district court that the text, statutory structure and legislative history of the Act make plain that the Congress did not grant the FDA such sweeping discretion,” circuit judge Karen L. Henderson wrote for the court.