Proposed Legislation Would Reverse Genus Decisions

March 30, 2022By Douglas B. Farquhar & Sara W. Koblitz

Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”).  Unless amended, the proposed legislation would reverse a Court determination that FDA had erroneously classified a frequently used contrast agent, barium sulfate, as a drug.  Our client Genus Medical Technologies, plaintiff in the cases decided by the courts and one of two distributors of barium sulfate in the United States, is seeking a revision to the proposed legislation.

By way of background, barium sulfate is ingested before some radiographic procedures studying the gastrointestinal tract. In 2017, FDA issued a warning letter to our client, Genus Medical Technologies, for distributing barium sulfate, which FDA characterized as an unapproved drug. After years of regulatory procedures and litigation in two federal courts (the District Court for the District of Columbia and the U.S. Court of Appeals for the D.C. Circuit), Genus’s position was vindicated: barium sulfate must be regulated as a medical device, not a drug, because the product achieves its primary intended purposes through its physical characteristics rather than through biological or metabolic action. The court decisions were subjects of prior blogposts (link here and here). After the government decided not to challenge the appellate court decision, FDA acceded to the decision and issued a Federal Register Notice discussing about how products would be transitioned if they had been classified as drugs inconsistent with the court decision (the Federal Register Notice was the subject of a blogpost linked here).

Congress is currently considering legislation that would revise statutes governing User Fees for drugs and medical devices, and a rider to that legislation has been proposed that would lump all contrast agents into the drug classification, resulting in huge expenses for Genus and other companies to market barium sulfate, which has been used safely and effectively for more than 120 years. The regulatory fees associated with introducing a drug, even a generic drug, to market, are around $400,000 in the first year (and $150,000 annually thereafter). By contrast, applications for marketing authorization for medical devices cost tens of thousands of dollars, followed by much more limited costs once the device is marketed.

Unless amended, the proposed legislation would isolate all contrast agents – including barium sulfate – from the well‐settled statutory and regulatory scheme that has, as the courts decided, dictated that products meeting the statutory definition of medical devices be classified and regulated as medical devices. Specifically, the FDC Act defines medical products by excluding from the definition of devices any products that achieve their primary intended purposes through chemical action in or on the body or through metabolic action, and has done so for about 50 years.

In initially trying to shoehorn barium sulfate into the drug category, FDA insisted that it needed to regulate all contrast agents as drugs based on a prior District Court decision (an argument the Courts rejected), and claimed that the change would be administratively convenient. Citing a case that says that FDA cannot regulate similar products differently, FDA decided to regulate all contrast agents as drugs while ignoring the fact that not all contrast agents are similar. Yet FDA insisted that all contrast agents needed to be regulated as drugs with no credible explanation for treating products that work differently as if they are the same. FDA appeared to be saying that its administrative convenience trumps the disparate safety and effectiveness concerns that arise in the context of drugs and devices.

While Genus would raise no objection to regulating the other products addressed by the legislation – radioactive drugs and OTC monograph drugs – as drugs, a simple amendment to the proposed legislation (linked to here) would limit the legislation’s effect on contrast agents to injectable contrast agents (this would cover, for example, iodine‐based solutions that are injected for computer tomography scans). Other contrast agents, like barium sulfate, which may have an oral, rectal, or dermal route of administration, would be classified and regulated as drugs or devices depending on the long‐standing statutory distinction: as drugs, if they achieve their primary intended purposes through chemical action in or on the body or through metabolic action.

While FDA argued in court that all contrast agents should be classified and regulated as drugs, there are important distinctions between those that achieve their primary intended effects through chemical or metabolic action, and those that do not. Radioactive drugs, and intravenously administered contrast agents, are capable of perfusing through or transforming tissues or cells. Consistent with an FDA Guidance, linked here, that elaborates on what chemical action means, these types of products are much more likely to be systemically distributed through the body, and could have results that are like those of pharmaceutical products. But, as FDA conceded, barium sulfate is not one of those products: the compound does not pass through tissue or transform cells. Instead, it absorbs X‐rays during radiographic procedures, resulting in contrast enhancement, which improves visualization of tissues.

Indeed, studies show that, under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form.

We will keep you posted on the progress of Genus’s proposed amendment, and this legislation.