Page:United States Statutes at Large Volume 111 Part 3.djvu/270

 Ill STAT. 2358 PUBLIC LAW 105-115—NOV. 21, 1997 have been previously published about the use of the drug or device covered by the information disseminated (unless the information already includes such bibliography). "(c) ADDITIONAL INFORMATION.— If the Secretary determines, after providing notice of such determination and an opportunity for a meeting with respect to such determination, that the information submitted by a manufacturer under subsection (b)(3)(B), with respect to the use of a drug or device for which the manufacturer intends to disseminate information, fails to provide data, analyses, or other written matter that is objective and balanced, the Secretary may require the manufacturer to disseminate— "(1) additional objective and scientifically soxmd information that pertains to the safety or effectiveness of the use and is necessary to provide objectivity and balance, including any information that the manufacturer has submitted to the Secretary or, where appropriate, a summary of such information or any other information that the Secretary has authority to make available to the public; and "(2) an objective statement of the Secretary, based on data or other scientifically sound information available to the Secretary, that bears on the safety or effectiveness of the new use of the drug or device. 21 USC "SEC. 552. 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 msinufacturer 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

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