
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360aaa-1]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
             Part D--Dissemination of Treatment Information
 
Sec. 360aaa-1. Information authorized to be disseminated


(a) Authorized information

    A manufacturer may disseminate information under section 360aaa of 
this title 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 360aaa-5(5) of this title), 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) of 
        this section, 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) of this 
section 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 360aaa of 
    this title and 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.

(June 25, 1938, ch. 675, Sec. 552, as added Pub. L. 105-115, title IV, 
Sec. 401(a), Nov. 21, 1997, 111 Stat. 2358.)

                         Termination of Section

        For termination of section by section 401(e) of Pub. L. 105-115, 
    see Effective and Termination Dates note set out under section 
    360aaa of this title.

                  Section Referred to in Other Sections

    This section is referred to in section 360aaa of this title.
