Congress Likely to Clarify Contrast Agent Dilemma: Attorney
While FDA continues to sift through public comments it requested (see earlier story) about how to comply with a court decision and move certain contrast agents from being regulated as drugs to devices, a new “legal insight” post sees Congress eventually stepping in to clarify that all contrast agents remain as drugs. The ongoing confusion stems from a 4/2021 decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, which affirmed a district court ruling that FDA is not afforded discretion when a combination product meets the definition of being both a device and a drug (see earlier story).
The legal insight from Epstein Becker & Green attorney James Boiani posits that if FDA proceeds to reclassify drugs that have been brought to market under the medical devices program then it should “expect a wave of litigation from the many affected parties…. For that reason, Congress may act soon to clarify that contrast agents and other products that have consistently been regulated as drugs for decades remain drugs. Legislation that would reaffirm the designation of these medical products as drugs would allow FDA to continue pressing work on a host of other important public health issues, rather than divert its attention to a protracted public process and potential litigation for hundreds, if not thousands, of products.”
Boiani further observes that if FDA were to reclassify only some drugs as medical devices but not others, it would go against a 1997 court decision — Bracco Diagnostics v. Shalala — that called for a uniform drug-based regulatory system for contrast agents. “Not only could inconsistent regulation harm competition, but it could create separate standards for safety, effectiveness, manufacturing, and promotion, and potentially create a variety of challenges across all the interrelated health regulatory regimes where the application of laws and policies turns on whether a product is a drug or device,” he writes.
Additionally, Boiani notes that having Congress clarify jurisdiction of an FDA product is not unprecedented. “Most recently, one could look to the 21st Century Cures Act of 2016, where Congress modified the statutory definition of a ‘device’ to clarify the scope of FDA software regulation. If Congress views the value of maintaining the current drug regulatory system to outweigh the value of upending it, and the associated issues the latter could cause, it may act soon to clarify the law and confirm” that contrast agents that have long been regulated as drugs remain drugs.