SEC. 552. [21 USC §360aaa–1] Information Authorized To Be Disseminated

(a) AUTHORIZED INFORMATION.—A manufacturer may disseminate information under section 551 on a new use only if the information—

(1) is in the form of an unabridged—

(A) reprint or copy of an article, peer-reviewed by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device involved, which was published in a scientific or medical journal (as defined in section 556(5)), which is about a clinical investigation with respect to the drug or device, and which would be considered to be scientifically sound by such experts; or

(B) reference publication, described in subsection (b), that includes information about a clinical investigation with respect to the drug or device that would be considered to be scientifically sound by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device that is the subject of such a clinical investigation; and

(2) is not false or misleading and would not pose a significant risk to the public health.

(b) REFERENCE PUBLICATION.—A reference publication referred to in subsection (a)(1)(B) is a publication that—

(1) has not been written, edited, excerpted, or published specifically for, or at the request of, a manufacturer of a drug or device;

(2) has not been edited or significantly influenced by such a manufacturer;

(3) is not solely distributed through such a manufacturer but is generally available in bookstores or other distribution channels where medical textbooks are sold;

(4) does not focus on any particular drug or device of a manufacturer that disseminates information under section 551and does not have a primary focus on new uses of drugs or devices that are marketed or under investigation by a manufacturer supporting the dissemination of information; and

(5) presents materials that are not false or misleading.