Intended Use Based on Actual Use
One of the most important regulatory concepts in the FDCA is that of “intended use.” That term plays a pivotal role in establishing the applicable regulatory requirements. Historically, intended use has been determined by the conduct of the manufacturer.
The intended use of a product is not based only on what words appear on the label, but what the manufacturer says about its product. A product would be regulated as a device if the manufacturer made diagnostic claims about it, even if the product itself was labeled RUO. The intended use of a product, though, has not been altered by the conduct of the purchaser. A manufacturer whose drug or device was approved for treating X does not face charges of off-label promotion because physicians use it to treat condition Y.
The draft document, however, states that the intended use of a product is altered by the conduct of its purchasers. According to FDA, “intended use may be shown by the circumstances surrounding the distribution of the product and the manufacturer's knowledge that its product is offered and used for a purpose for which it is neither labeled nor advertised.”
Under the draft guidance, a company selling an RUO or IUO product that learns a customer is using a product for diagnostic purposes should “halt” sales of that product. This termination of sales to customers should take place even in the absence of actual knowledge, i.e., if the manufacturer has reason to know of the diagnostic usage.
This element of the draft guidance, if adopted, would have major repercussions for companies selling RUO or IUO products. Read literally, the policy would require the immediate cessation of sales to an RUO or IUO laboratory customer based on any diagnostic usage. No transition period is currently permitted under the draft guidance. This could be very disruptive to the manufacturer, the laboratory, and patients.
More broadly, this approach potentially represents a shift in FDA's approach to offlabel use for FDA-regulated products. Drugs and devices are routinely used off-label. It is unclear what impact, if any, the approach adopted here toward RUOs and IUOs would have if applied to other FDA-regulated products in which off-label use occurs.
Guidance documents are not legally binding. Unlike statutes and regulations, guidance documents do not have the force and effect of law. FDA could not take enforcement action against a manufacturer on the ground that it “violated” a guidance document.
While FDA could cite a guidance document as evidence of the agency's interpretation of the law, in an enforcement action FDA would need to establish a violation of a legally binding requirement, such as a statute or regulation. A draft guidance document has even less legal significance.
Nevertheless, the issuance of the draft guidance document does have consequences. It signals FDA's intention to limit the sales of RUOs and IUOs. Taking this cue, some suppliers reportedly have already begun to restrict sales of RUO products to laboratories. If a final guidance document is issued in substantially the same form, FDA probably would send out letters to RUO and IUO companies alerting them to FDA's position.
Certainly, the release of a final guidance document will cause many companies to change their behavior, regardless of the fact that the document is not itself enforceable. Issuance of a final guidance substantially curbing RUO products may also have a negative effect on investment in companies offering RUOs and, potentially, some of their customers.
The comment period for the draft guidance document closes on August 30, 2011. FDA has provided its views on how RUOs and IUOs should be regulated. It will be interesting indeed to see what comments are submitted in response.