Court Allowing FDA to Regulate Medical Practice: Attorneys
A 9th Circuit Court of Appeals decision appears to “impermissibly grant FDA authority to regulate the practice of medicine and to further muddy the regulatory morass governing off-label use of products,” according to attorneys Anne Walsh and Andrew Hull (Hyman, Phelps & McNamara). Writing in their firm’s FDA Law Blog, the two discuss the felony conviction and 48-month imprisonment of a Nevada urologist for conspiracy to commit adulteration under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Complaints by the doctor’s medical assistants to the state medical board that he was reusing single-use needle guides in multiple invasive prostate procedures led FDA’s Office of Criminal Investigations (OCI) to open an investigation.
The post says that the relevant section of the act discusses adulteration of items that are “held for sale” and the doctor argued that the needle guides were not held for sale because he never transferred their ownership to the patients, instead simply using them in treating patients. The district federal court rejected this argument as did the appeals court.
On appeal, the doctor also claimed that his reuse of single-use needle guides was an allowable off-label use of a medical device.
“Although the outcome … may have been appropriate based on the egregious nature of … the conduct, the decision unfortunately clouds, rather than clarifies, important issues,” the attorneys write. “There can be no dispute that Congress did not intend FDA to regulate the practice of medicine via the FFDCA.”
They note that other remedies are available to deal with such behavior either through state medical board or malpractice suits. However, they say, “the Ninth Circuit holding criminalizes the doctor’s practice of medicine via a logically tortuous path by characterizing his use of a device in treating patients as a commercial act (holding for sale). And the court left open questions such as whether a physician’s use of a device in the provision of free medical services or the use of general office equipment to treat a patient would be covered. The court also dismissed [the doctor’s] contention that his actions constituted permissible off-label use under the FFDCA.”
They report that the appeals court opinion said that while a doctor may exercise professional judgment in the off-label use of unadulterated products, nothing in the FFDCA or caselaw suggests that the use of adulterated products is ever permissible. “This less-than-clear explanation carries a strong risk of being taken out of context,” Walsh and Hull write. “The court’s ‘bright-line’ rule prohibiting the use of adulterated products fails to consider the nuances of the FFDCA, which considers a device adulterated if it has a new intended use for which it is required to have, but lacks, pre-market approval. What the court should have clarified is that its holding is limited to products that are adulterated … because they were held under insanitary conditions, which is what was charged here, and not because they were being used off-label (single use versus reuse).”
In passing, the attorneys also reference the recent media and congressional interest in OCI’s work and ask whether its involvement in this case, which they say may have been more appropriately adjudicated by the state medical board and medical malpractice suits, is another example of misplaced OCI attention.