[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.101]



[Page 445-446]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED 

DRUGS, BIOLOGICS, AND DEVICES--Table of Contents

 

                Subpart B_Information To Be Disseminated

 

Sec.  99.101  Information that may be disseminated.





    (a) A manufacturer may disseminate written information concerning 

the safety, effectiveness, or benefit of a use not described in the 

approved labeling for an approved drug or device or in the statement of 

intended use for a cleared device, provided that the manufacturer 

complies with all other relevant requirements under this part. Such 

information shall:

    (1) Be about a drug or device that has been approved, licensed, or 

cleared for marketing by FDA;

    (2) Be in the form of:

    (i) An unabridged 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. In addition, the article 

must be about a clinical investigation with respect to the drug or 

device and must be considered to be scientifically sound by the experts 

described in this paragraph; or

    (ii) An unabridged reference publication that includes information 

about a clinical investigation with respect to the drug or device, which 

experts qualified by scientific training or experience to evaluate the 

safety or effectiveness of the drug or device that is the subject of the 

clinical investigation would consider to be scientifically sound;

    (3) Not pose a significant risk to the public health;



[[Page 446]]



    (4) Not be false or misleading. FDA may consider information 

disseminated under this part to be false or misleading if, among other 

things, the information includes only favorable publications when 

unfavorable publications exist or excludes articles, reference 

publications, or other information required under Sec.  99.103(a)(4) or 

the information presents conclusions that clearly cannot be supported by 

the results of the study; and

    (5) Not be derived from clinical research conducted by another 

manufacturer unless the manufacturer disseminating the information has 

the permission of such other manufacturer to make the dissemination.

    (b) For purposes of this part:

    (1) FDA will find that all journal articles and reference 

publications (as those terms are defined in Sec.  99.3) are 

scientifically sound except:

    (i) Letters to the editor;

    (ii) Abstracts of a publication;

    (iii) Those regarding Phase 1 trials in healthy people;

    (iv) Flagged reference publications that contain little or no 

substantive discussion of the relevant clinical investigation; and

    (v) Those regarding observations in four or fewer people that do not 

reflect any systematic attempt to collect data, unless the manufacturer 

demonstrates to FDA that such reports could help guide a physician in 

his/her medical practice.

    (2) A reprint or copy of an article or reference publication is 

``unabridged'' only if it retains the same appearance, form, format, 

content, or configuration as the original article or publication. Such 

reprint, copy of an article, or reference publication shall not be 

disseminated with any information that is promotional in nature. A 

manufacturer may cite a particular discussion about a new use in a 

reference publication in the explanatory or other information attached 

to or otherwise accompanying the reference publication under Sec.  

99.103.