The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second time, dealing industry a victory in the sometimes contentious arena of product classification decisions.
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| Prevor's Diphoterine Skin Wash--Courtesy of Prevor |
After all, as the law firm Faegre Baker Daniels points out, the fee for 510(k) application is $5,018 in fiscal year 2015, compared to $2.34 million for a new drug application (NDA). And that's before factoring in the increased cost and difficulty of meeting the NDA requirements.
The ruling will likely tilt the balance in favor of more device classifications in combination product decisions because Judge Rosemary Collyer rejected FDA's argument that a product (in this case Prevor's skin wash) should be classified as a drug "if the available evidence indicates that chemical action achieves, or, in other words, meaningfully contributes to, the product's primary intended purposes," as stated in the agency's Dec. 2013 motion for summary judgment.
Prevor argued that the spray's delivery device (an aerosol can) and rinsing mechanism enabling physical displacement of toxins, qualify the skin wash as a device. But ultimately, the decision turned on the specifics of the Federal Food, Drug, and Cosmetic Act and semantics such as the equivalence (or nonequivalence in the opinion of Collyer) of "achieves" and "meaningfully contributes."
After the court vacated FDA's previous attempt to call the skin wash a drug in 2012, FDA once again declared DSW a drug by offering an alternative justification, but Collyer didn't buy the new argument this time either. "The statute does not demand that FDA quantify the exact contribution of a product's ultimate goal [in order to classify it as a drug]. However, it does require more than simply finding that the product would not work as claimed without chemical action," Collyer ruled Sept. 9. But she declined to simply declare the skin wash a device, meaning the 5-year dispute continues.
FDA declined to comment to FierceMedicalDevices, leaving stakeholders wondering whether another appeal is in the works. The agency has has historically preferred to classify combination products as drugs destined for the more rigorous approval pathway. According to law firm Sidley Austin, 16 of the 23 products deemed combination products (classic examples include asthma inhalers and drug eluting stents) were designated as drugs in fiscal year 2012.
"The case is a victory for Prevor, but obviously not a 100% victory because it still gives Prevor yet another opportunity try to find a reason why this should be a drug instead of a device," said Richard Samp, chief counsel of the nonprofit Washington Legal Foundation, in an interview.
Nevertheless the decision is a victory for industry because it's going to stop FDA from trying to expand the definition of a drug, according to Samp, who added that the two rulings call into question the agency's Feb. 2014 combination product draft guidance. He said the ruling is "going to help make clear that FDA should act in accordance with the its authorizing statue and not based on what it thinks is best for public health."
- read the opinion
- here's analysis from Faegre Baker Daniels
- and background information from Sidley Austin