Page:United States Statutes at Large Volume 111 Part 3.djvu/275

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2363 "(2) The terms health insurance issuer' and 'group health plan' have the megining given such terms under section 2791 of the Public Health Service Act. "(3) The term 'manufacturer' means a person who manufactures a drag or device, or who is licensed by such person to distribute or market the drug or device. "(4) The term 'new use'— "(A) with respect to a drug, means a use that is not included in the labeling of the approved drug; and "(B) with respect to a device, means a use that is not included in the labeling for the approved or cleared device. "(5) The term 'scientific or medical journal' meems a scientific or medical publication— "(A) that is published by an organization— "(i) that has an editorial board; "(ii) that utilizes experts, who have demonstrated expertise in the subject of an article under review by the organization and who are independent of the organization, to review and objectively select, reject, or provide comments about proposed articles; and "(iii) that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors or contributors involved with the journal or organization; "(B) whose articles are peer-reviewed and published in accordance with the regular peer-review procedures of the organization; "(C) that is generally recognized to be of national scope and reputation; "(D) that is indexed in the Index Medicus of the National Library of Medicine of the National Institutes of Health; and "(E) that is not in the form of a special supplement that has been funded in whole or in part by one or more manufacturers. "SEC. 557. RULES OF CONSTRUCTION. 21 USC 360a£i8i—€ "(a) UNSOLICITED REQUEST.— Nothing in section 551 shall be construed as prohibiting a manufacturer from disseminating information in response to an unsolicited request from a health care practitioner. "(b) DISSEMINATION OF INFORMATION ON DRUGS OR DEVICES NOT EVIDENCE OF INTENDED USE.—Notwithstanding subsection (a), (f), or (o) of section 502, or any other provision of law, the dissemination of information relating to a new use of a drug or device, in accordance with section 551, shall not be construed by the Secretary as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. Such dissemination shall not be considered by the Secretary as labeling, adulteration, or misbranding of the drug or device. "(c) PATENT PROTECTION.—Nothing in section 551 shall affect patent rights in any manner. "(d) AUTHORIZATION FOR DISSEMINATION OF ARTICLES AND FEES FOR REPRINTS OF ARTICLES.— Nothing in section 551 shall be construed as prohibiting an entity that publishes a scientific journal

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