Law

[I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

In addition, FDA is proposing to amend its existing intended use regulations for drugs and devices by inserting in §§201.128 and 801.4 a reference to the proposed rule to clarify the interplay between these regulations and this proposed rule, and to conform §§201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices.

FDA is also proposing changes to §§201.128 and 801.4.  First, the proposed rule would insert a reference to §1100.5 to clarify the interplay between these regulations and the proposed rule.  Second, as discussed previously, the Agency does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use (see Ref. 5). Accordingly, FDA is taking this opportunity to amend §§201.128 and 801.4 to better reflect FDA’s interpretation and application of these regulations.  These changes would not reflect a change in FDA’s approach regarding evidence of intended use for drugs and devices.  These clarifying changes to the intended use regulations would apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.

The words intended uses or words of similar import in [differing cross references] of this chapter refer to the objective intent of the persons legally responsible for the labeling of [drugs/devices].  The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.  This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.  It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.  The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer.  If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the [drug/device], such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

The words intended uses or words of similar import in [differing cross references] of this chapter refer to the objective intent of the persons legally responsible for the labeling of [drugs/devices].  The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.  This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.  It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.  [Objective intent cannot be shown by truthful promotion alone.  Truthful and nonmisleading promotional speech consisting of, for example, summaries and reprints of published studies, claims approved for use on similar [drugs/devices], and/or proactive truthful statements and dialogues with doctors about sues for which the article is neither labeled nor advertised is not evidence of objective intent to change an article’s intended use.]  The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer.  If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the [drug/device], such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

Section 1447(c) of title 28, United States Code, is amended by adding at the end the following: “A motion for remand, and any opposition thereto, may include affidavit or other evidence showing a plausible claim for relief against each nondiverse defendant, or the lack thereof, or indicating a good faith intention to prosecute the action against each nondiverse defendant or to seek a joint judgment, or the lack of such a good faith intent.  The district court shall deny a motion to remand if it finds that the complaint does not state a plausible claim for relief against a nondiverse defendant under applicable State law or there is no good faith intention to prosecute the action against a nondiverse defendant or to seek a joint judgment.”