[Federal Register Volume 62, Number 60 (Friday, March 28, 1997)]
[Notices]
[Pages 14912-14917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95P-0110]


Prescription Drug Advertising and Promotional Labeling; 
Development and Use of FDA Guidance Documents; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: As part of ongoing efforts initiated by the Food and Drug 
Administration (FDA) in March 1996 to ensure meaningful public 
participation in the guidance document development process, FDA's 
Division of Drug Marketing, Advertising, and Communications (DDMAC) is 
requesting public comment on guidance documents relating to 
prescription drug advertising and labeling. DDMAC has identified three 
general types of guidance documents on which it is seeking public 
comment. Specifically, DDMAC is requesting public comment on the 
rescission of guidances identified by DDMAC as obsolete, the revision 
and reissuance of DDMAC guidances that address current issues, and 
currently proposed guidance documents and suggestions of topics for new 
guidances that DDMAC may develop.

DATES: Written comments by June 26, 1997.

ADDRESSES: Submit written requests for copies of the guidances under 
review by DDMAC to the Freedom of Information Staff (HFI-35), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Submit 
written comments on the guidances or related issues to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments 
are to be submitted, except that individuals may submit one. Comments 
should be identified with the docket number found in brackets in the 
heading of this document. Copies of the guidances under review by DDMAC 
are available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Melissa M. Moncavage, Center for Drug 
Evaluation and Research (HFD-40), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2828, e-mail: 
<a href="/cdn-cgi/l/email-protection#e686868b8988858790878183a685828394c8808287c8818990">``<span class="__cf_email__" data-cfemail="3b565455585a4d5a5c5e7b585f5e49155d5f5a155c544d">[email protected]</span></a>.''

SUPPLEMENTARY INFORMATION: Issues relating to FDA's development and 
issuance of guidance documents were raised in a citizen petition 
submitted by the Indiana Medical Devices Manufacturers Council, Inc. 
(IMDMC) (see Docket No. 95P-0110). The IMDMC petition requested that 
FDA control the initiation, development, and issuance of guidance 
documents by written procedures that ensure the appropriate level of 
meaningful public participation. In response to the petition, FDA 
agreed to take steps to improve the agency's guidance document 
procedures.
    In the Federal Register of March 7, 1996 (61 FR 9181), FDA 
published a notice that set forth its proposal on how best to improve 
its guidance document procedures and solicited comment on these and 
additional ideas for improvement (March 1996 notice). On April 26, 
1996, the agency held a public meeting to discuss these issues further. 
The comment period for the March 7 notice closed on June 5, 1996. In 
the Federal Register of February 27, 1997 (62 FR 8961), FDA published a 
notice explaining how the agency will proceed in the future with 
guidance document development, issuance, and use. The notice included 
the agency document entitled ``Good Guidance Practices'' (the GGP's 
document), which sets forth the agency's policies and procedures for 
developing, issuing, and using guidance documents.
    In the GGP's document, the agency defines ``guidance documents'' to 
include documents prepared for FDA staff, applicants and sponsors, and 
the public that: (1) Relate to the processing, content, and evaluation 
and approval of submissions; (2) relate to the design, production, 
manufacturing, and testing of regulated products; (3) describe the 
agency's policy and regulatory approach to an issue; or (4) establish 
inspection and enforcement policies and procedures. ``Guidance 
documents'' do not include documents relating to internal FDA 
procedures, agency reports, general information documents provided to 
consumers, speeches, journal articles and editorials, media interviews, 
press materials, warning letters, or other communications directed to 
individual persons or firms.
    Guidance documents do not create or confer any rights for or on any 
person and do not operate to bind FDA or the public. Rather, they 
explain the agency's current thinking on a certain subject. However, a 
company affected by a guidance may use an alternative approach if the 
alternative approach satisfies the requirements of the applicable 
statute, regulations, or both. A guidance document cannot itself be the 
basis for an enforcement action.
    FDA has adopted a two-level approach to the development of guidance 
documents. The procedures for developing a guidance document will 
depend on whether that guidance document is a ``level 1'' guidance or a 
``level 2'' guidance. Level 1 guidance documents generally include 
guidance that sets forth first interpretations of statutory or 
regulatory requirements, changes in interpretation or policy that are 
of more than a minor nature, unusually complex scientific issues, or 
highly controversial issues. Level 1 guidance documents are directed 
primarily to applicants or sponsors or other members of the regulated 
industry. Level 2 guidance documents include all other guidance 
documents. In general, the agency will solicit public comment during 
the development of level 1 guidance documents. For level 2 guidance 
documents, the agency may choose to solicit comment before implementing 
a guidance, but in general an opportunity for public comment will be 
provided upon issuance of the guidance document. (See FDA GGP's.)
    The agency also is making efforts to keep the public up to date on 
the status of agency guidance development and to provide the public an 
opportunity to suggest possible topics for document development or 
revision.
    DDMAC guidances on achieving compliance with the prescription drug 
advertising and labeling statutes and regulations have been issued to 
the pharmaceutical industry since 1970 in various forms, often as 
letters or guidance papers. As a result of FDA's GGP effort, DDMAC has 
decided to reissue its guidance documents in a standardized format and 
grouped by common topic, such as content, format, class of drugs, or 
how to interact with DDMAC. To that end, DDMAC is undertaking a review 
of all such guidances to determine the following: (1) Which guidances 
are obsolete; (2) which guidances address current issues, but may need 
revision; and (3) whether there are new topics on which DDMAC should 
develop guidance documents. Once the guidance review process is 
completed, new and reissued DDMAC guidances will be made available, in

[[Page 14913]]

paper and electronic format, as they are completed.
    DDMAC also has examined systematically its guidance development 
process and is implementing changes to ensure meaningful public 
participation in its guidance development process. DDMAC is seeking 
public comment on the following three types of guidance documents: List 
1 contains DDMAC guidance documents that have been, or will be, 
rescinded because they are obsolete; List 2 contains DDMAC guidance 
documents (level 1 and level 2) that address current issues, but that 
may need some revision before they are reissued; and List 3 contains 
suggestions for guidance documents DDMAC may develop to address current 
prescription drug advertising and labeling issues.
    Interested persons may, on or before June 26, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this document. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday. Anyone with general comments, 
concerns, or questions about DDMAC guidance documents may submit their 
comments at any time to the Dockets Management Branch.

I. List 1--DDMAC Guidance Documents Considered Obsolete

    List 1 contains the titles and dates of all guidance documents on 
prescription drug advertising and labeling that have been reviewed by 
DDMAC and that have been rescinded or will be rescinded by this 
document because they are obsolete; some may have been superseded by 
subsequent policies, and some are being revised and will be reissued as 
described in List 2 of this notice. The guidances are listed in 
chronological order, and a description of the original guidance is 
included with a statement explaining its status. Guidances in this list 
that were superseded by subsequent guidances or are being revised are 
cross-referenced to the proposed revised guidances in Lists 2 and 3. 
For example, the letter dated June 27, 1970, in List 1 is cross-
referenced to the proposed revised guidance in List 2.D.4 ``Oral 
Contraceptive Products--Differentiation Claims.'' Guidances in List 1 
that are being revised in new guidances will remain in effect until the 
revised guidance is published in final form.
    Although it may be rescinding a guidance on a specific issue at 
this time, the agency may consider the need to reissue a guidance on 
that issue. Therefore, DDMAC welcomes comments on the rescission, or 
future rescission, of the guidances in List 1 and encourages parties to 
submit their comments to the Dockets Management Branch (address above).
    1. Letter dated June 27, 1970--This letter to oral contraceptive 
manufacturers objected to attempts to differentiate products based on 
alleged thromboembolic risk with higher estrogen levels. This risk 
theory was based on information described as ``British data.'' This 
guidance was superseded by guidances dated June 19, 1991, and January 
31, 1992, in this list. These latter guidances will be incorporated 
into 2.D.4, ``Oral Contraceptive Products--Differentiation Claims.''
    2. Statement dated March 18, 1971--This statement to all 
manufacturers of antibiotic drugs addressed the use of in vitro data to 
support claims that an antibiotic is bactericidal. This guidance was 
superseded by the guidance dated September 1994 in this list. The 
latter guidance will be incorporated into guidance 2.D.2, ``Anti-
infective Drug Products.''
    3. Guidance dated 1971--This guidance to all manufacturers of 
psychotropic drugs requested firms to stop the use of claims suggesting 
the use of these products for everyday anxieties. This guidance was 
revised in the July 25, 1985, guidance in this list, which was later 
rescinded.
    4. Guidance dated October 8, 1974--This guidance from Commissioner 
Schmidt to Synapse Communication Services stated that educational 
material and programs could be considered labeling. This guidance will 
be combined with the ``Sabshin criteria'' guidance, May 22, 1975, in 
this list, to create 2.A.6, ``Scientific and Educational Materials--
Criteria for Independence.''
    5. Guidance dated May 22, 1975--This guidance detailed criteria to 
be considered when judging the independence of a publication for 
determination of labeling status. These criteria are commonly called 
the ``Sabshin criteria.'' This guidance will be combined with the 
guidance dated October 8, 1974, of this list, to create 2.A.6, 
``Scientific and Educational Materials--Criteria for Independence.''
    6. Letter dated October 6, 1975--This letter to all manufacturers 
of radiopharmaceutical products advised of the applicability of the 
advertising and labeling regulations to the promotion of 
radiopharmaceutical products. This guidance was issued at the time that 
these products first came under the prescription drug requirements. 
Because it is now generally understood that radiopharmaceuticals are 
prescription drugs, this guidance is rescinded.
    7. Guidance dated February 11, 1977--This guidance on the 
acceptability of claims of quality control procedures in reminder 
promotion was primarily intended for generic drug manufacturers. Since 
the inception of the generic drug rating system, generic drug 
manufacturers have been able to use the ratings in FDA's Approved Drug 
Products publication to reflect the status of their products. 
Therefore, this guidance is rescinded.
    8. Guidance dated February 14, 1977--This second guidance to 
radiopharmaceutical product manufacturers advised them of the 
prescription status of their products and the applicability of FDA 
regulations. Because it is now generally understood that 
radiopharmaceuticals are prescription drugs, this guidance is 
rescinded.
    9. Guidance dated June 28, 1978--This guidance addressed boxed 
warnings in brief summaries for estrogen products. The warnings 
addressed the increased risks of endometrial carcinoma and use in 
pregnancy. When this guidance was issued, these products had new boxed 
warnings in their labeling. Because the warning information is now 
routinely included in all advertising, this guidance is rescinded.
    10. Guidance dated early 1980's--This guidance presented conditions 
under which an industry press release will not be considered labeling. 
This guidance will be combined with the guidance in this list dated 
July 24, 1991, on video news releases to create 2.A.5, ``Print and 
Video News Releases.''
    11. Guidance dated early 1980's--This guidance stated conditions 
under which the dissemination of sole-sponsored publications by or on 
behalf of the drug sponsor would not be regulated as labeling. The 
guidance will be revised to create 2.A.7, ``Single-Sponsored 
Publications--Criteria for Independence.''
    12. Guidance dated April 6, 1981--This guidance to all 
manufacturers of estrogen products addressed claims for the use of 
estrogen products for vasomotor symptoms and other symptoms of 
menopause. Because the products have been approved for these uses, this 
guidance is rescinded.
    13. Guidance dated June 16, 1981--This guidance to all 
manufacturers of

[[Page 14914]]

oral contraceptives addressed the use of the results of the ``Walnut 
Creek Study'' in claims of lowered side-effect risk. FDA's position was 
that the study did not support any changes in the risk information at 
that time. Because the study is no longer used in promotion, this 
guidance is rescinded.
    14. Guidance dated April 22, 1982--This guidance addressed the 
agency's position regarding responses to solicited and unsolicited 
requests for drug product information. The guidance will be 
incorporated into guidance 2.A.8, ``Solicited and Unsolicited Requests 
for Information.''
    15. Guidance dated July 6, 1982--This guidance to industry 
addressed the scientific support necessary for comparative advertising 
disseminated by or on behalf of the drug sponsor. This guidance will be 
combined with the guidances in this list dated October 27, 1988, and 
February 22, 1994, to create 2.A.1, ``Comparative Promotional 
Materials.''
    16. Guidance dated July 21, 1982--This guidance to all 
manufacturers of purified insulin products addressed claims of 
superiority based on the purification of the product by removing, for 
example, pro-insulin and animal proteins. With the development of 
recombinant deoxyribonucleic acid (DNA) human insulins, the promotion 
issue is no longer relevant to these products. Therefore, this guidance 
is rescinded.
    17. Guidance dated July 22, 1982--This guidance to industry 
addressed limitations on and formats for advertising not-yet-approved 
drug products. This document was superseded by guidances in this list 
dated August 1985, August 1986, and April 1994.
    18. Guidance dated August 10, 1982--This guidance to all 
manufacturers of sustained-release theophylline products addressed the 
use of pharmacokinetic and biopharmaceutic data to support clinical 
claims. Because those claims are no longer used to differentiate 
products, this guidance is rescinded.
    19. Guidance dated November 10, 1982--This guidance to all 
advertisers of benzodiazepine products addressed clinical claims 
supported by nonclinical or pharmacokinetic data. This guidance was 
superseded by a guidance in this list dated July 25, 1985.
    20. Memorandum dated March 15, 1983--This memorandum from the 
Division of Drug Monographs to manufacturers described data and 
calculations needed to support claims of zero-order kinetics with 
clinical implications. Because issues of constant absorption and 
product differentiation are no longer used in promotion, this guidance 
is rescinded.
    21. Letter dated September 19, 1983--This letter to manufacturers 
of nitroglycerin patches provided summary wording regarding the less-
than-effective status of those products. The summary was to be used in 
place of the Drug Efficacy Study Investigation statement wording 
required in the regulations. This guidance will be revised to create 
2.D.6, ``Transdermal Nitroglycerin Products.''
    22. Guidance dated December 30, 1983--This guidance to 
manufacturers of once-daily theophylline products addressed submission 
of promotional material. This guidance was effective for only 6 months 
and, therefore, is rescinded.
    23. Letter dated February 16, 1984--This letter to all 
manufacturers of oral contraceptives concerned a study by Pike et al. 
(published in Lancet) and discussed relative potencies of progestins; 
it could not be used as the basis for promotional claims. Because this 
study is no longer used in promotion, this guidance is rescinded.
    24. Guidance dated December 20, 1984--This guidance to all 
manufacturers of antimicrobial and antimycotic agents detailed how the 
terms: ``Clinical cure, bacteriological cure, and improvement'' were to 
be used and defined in promotion. This guidance was later clarified in 
the February 27, 1986, document in this list. Both of these documents 
will be revised and combined with the March 18, 1971, guidance document 
in this list on antimicrobial and antimycotic promotion to create 
2.D.2, ``Anti-infective Drug Products.''
    25. Letter dated July 25, 1985--This letter to all manufacturers of 
benzodiazepine products concerned certain promotional statements. This 
guidance revised the 1971 guidance in this list on psychotropic drugs. 
Because these products are no longer promoted using such statements, 
this guidance is rescinded.
    26. Guidance dated August 1985--This guidance was addressed to the 
industry on preapproval promotion. This guidance was superseded by a 
guidance dated August 1986 and two guidances dated April 1994 in this 
list.
    27. Guidance dated September 1985--This guidance to the industry 
described what FDA would view as institutional, corporate, or health 
messages. This guidance was revised in a guidance in this list dated 
June 6, 1988. The concepts in these guidances will be revised to create 
2.A.4, ``Institutional and Help-Seeking Advertisements,'' and 2.C.3, 
``Preapproval Promotion.''
    28. Guidance dated September 1985--This guidance to the industry 
addressed the use of overprinting of images or promotional phrases over 
the brief summary wording. This guidance will be slightly revised to 
create 2.B.2, ``Overprinting of Images or Promotional Phrases.''
    29. Guidance dated February 27, 1986--This guidance to industry 
clarified the December 20, 1984, guidance on antimicrobial drug 
promotion. This guidance will be revised and combined with the March 
18, 1971, guidance in this list concerning antibiotic and antimycotic 
promotion to create 2.D.2, ``Anti-infective Drug Products.''
    30. Letter dated May 2, 1986--This letter to manufacturers of oral 
contraceptive products specified that patient booklets should contain 
the approved patient package insert as a permanent part of the booklet. 
Because the principles regarding labeling requirements are well 
established with this product class, this guidance is rescinded.
    31. Guidance dated August 1986--This guidance to industry 
consolidated and added provisions to the July 22, 1982, and September 
1985 guidances in this list regarding preapproval promotion 
disseminated by or on behalf of the drug sponsor. The August 1986 
guidance specified formats for preapproval drug promotion. The guidance 
was later superseded by two documents, both dated April 1994, and 
described later in List 1.
    32. Guidance dated December 1987--This guidance to the industry 
noted that proposed revisions to the investigational new drug 
regulations could affect the preapproval promotion guidance documents 
previously issued. Because the content of the guidance went through 
notice-and-comment rulemaking and was codified in the Code of Federal 
Regulations (21 CFR 312.7), this guidance is rescinded.
    33. Guidance dated March 1988--This guidance described the process 
for the review of proposed material to be relied on by industry as 
official agency action. This guidance was superseded by the document 
dated July 1993, in List 1.
    34. Guidance dated June 6, 1988--This guidance to industry revised 
the September 1985 guidance concerning institutional and disease-
oriented promotional messages. The concepts in this guidance will be 
revised and incorporated into 2.A.4, ``Institutional and Help-Seeking 
Advertisements,'' and 2.C.3, ``Preapproval Promotion.''
    35. Letter dated October 27, 1988--This letter was addressed to 
industry with attached excerpts from a speech

[[Page 14915]]

describing the criteria for comparative promotional claims. This 
guidance has been revised and will be combined with documents dated 
July 7, 1982, and February 22, 1994, in this list to create 2.A.1, 
``Comparative Promotional Materials.''
    36. Letter dated January 19, 1990--This letter to all manufacturers 
of transdermal nitroglycerin products concerned the inclusion of a 
double-boxed warning from the approved labeling in the brief summaries. 
This guidance was applicable for 6 months and, therefore, is rescinded.
    37. Letter dated June 19, 1991--This letter to all manufacturers of 
oral contraceptives discussed the use of claims of hormonal activity to 
differentiate products. The guidance also recommended against consumer 
advertising. A guidance dated January 31, 1992, rescinded the 
recommendation against consumer advertising. The remaining guidance 
topics will be revised to create 2.D.4, ``Oral Contraceptive Products--
Differentiation Claims.''
    38. Guidance dated July 24, 1991--This guidance to all 
manufacturers stated that video news releases would be considered 
labeling and should be submitted under the provisions of 21 CFR 314.81. 
This guidance will be revised to create 2.A.5, ``Print and Video News 
Releases.''
    39. Letter dated January 31, 1992--This letter to all manufacturers 
of oral contraceptives clarified the June 19, 1991, letter in this list 
and removed the recommendation against consumer promotion. This 
document will be revised and combined with other guidance documents 
concerning oral contraceptive promotion to create 2.D.4, ``Oral 
Contraceptive Products--Differentiation Claims.''
    40. Letter dated February 13, 1992--This letter to nicotine 
transdermal system manufacturers addressed promotional concepts and 
information and considerations for reminder messages to consumers. This 
guidance was revised and will be combined with the September 11, 1992, 
guidance in this list to create 2.D.5, ``Transdermal Nicotine 
Products.''
    41. Guidance dated June 5, 1992--This guidance to all manufacturers 
of aerosol inhalation steroid products stated that a caution statement 
should be included in all promotion. The guidance will be slightly 
revised to create 2.D.1, ``Aerosol Steroid Safety Information.''
    42. Letter dated June 22, 1992--This letter to all manufacturers of 
ionic and nonionic contrast media discussed the need to use data to 
substantiate certain claims that were used to differentiate products. 
This guidance will be slightly revised to create 2.D.3, ``Ionic and 
Nonionic Contrast Media.''
    43. Letter dated September 11, 1992--This letter to all nicotine 
transdermal system manufacturers outlined critical points regarding 
advertisements and promotional material. This guidance will be revised 
and combined with the February 13, 1992, guidance in this list to 
create 2.D.5, ``Transdermal Nicotine Products.''
    44. Letter dated May 20, 1993--This letter to industry listed 
product exhibits and programs naming products in program books for 
professional meetings. In light of the current format in program books, 
this guidance is rescinded.
    45. Guidance dated July 1993, ``Current Issues and Procedures''--
This guidance addressed six topics. The topics in this document will be 
separated, and new single-topic guidances will be created or will be 
combined with other guidances with similar topics into new guidances. 
The new documents that will be created from these six topics follow:
    a. Issues relating to filing submissions with DDMAC will be 
addressed in 2.C.2, ``Filing Requirements and Other Communication for 
Advertising and Labeling.''
    b. Issues relating to communicating with DDMAC by facsimile and 
letter will be addressed in 2.C.2, ``Filing Requirements and Other 
Communication for Advertising and Labeling.''
    c. Issues relating to submitting foreign language material will be 
addressed in 2.C.1, ``Data on File and Foreign Language Publications 
References.''
    d. Issues regarding submitting proposed direct-to-consumer 
advertising will be addressed in 3.2, ``Direct-to-Consumer Promotion.''
    e. Issues regarding electronic material will be addressed in 2.C.2, 
``Filing Requirements and Other Communication for Advertising and 
Labeling.''
    f. Issues dealing with launch campaigns will be addressed in 2.C.4, 
``Prepublication Review of Promotional Materials.''
    46. Guidance dated July 1993--This guidance to industry revised and 
reissued the March 1988 guidance on submission of material for 
prepublication review and comment. This guidance will be combined with 
the launch campaign topic in the preceding July 1993 guidance and the 
March 1994 guidance in List 1 to create 2.C.4, ``Prepublication Review 
of Promotional Materials.''
    47. Guidance dated August 1993--This guidance to industry clarified 
the requirements for telephone advertisements. This guidance will be 
revised in 2.A.9, ``Telephone Advertisements.''
    48. Guidance dated February 22, 1994--This guidance to industry 
addressed comparative efficacy claims for nonsteroidal anti-
inflammatory drugs and equally prominent information on adverse 
effects. This guidance will be revised and combined with the July 6, 
1982, and October 27, 1988, guidances and the pertinent topic in the 
April 1994 ``Current Issues and Procedures'' guidance in this list to 
create 2.A.1, ``Comparative Promotional Materials.''
    49. Guidance dated March 1994--This guidance to industry addressed 
the submission of proposed launch promotional material for review. This 
guidance will be combined with topics in the July 1993 ``Current Issues 
and Procedures'' and the other July 1993 guidance in this list to 
create 2.C.4, ``Prepublication Review of Promotional Materials.''
    50. Guidance dated April 1994--This guidance to industry addressed 
promotion of products prior to approval, which superseded the August 
1986 document. This guidance will be combined with the following April 
1994 guidance, part a., to create 2.C.3, ``Preapproval Promotion.''
    51. ``Current Issues and Procedures'' guidance dated April 1994--
This guidance to industry covered 10 topics. The topics in this 
guidance will be separated, and new single-topic guidances will be 
created or will be combined with other guidances with similar topics 
into revised guidances. The revised guidances that will be created from 
these 10 topics follow:
    a. Preapproval promotion issues will be addressed in 2.C.3, 
``Preapproval Promotion.''
    b. Issues related to brand and generic name presentation will be 
addressed in 2.B.3, ``Placement of Brand and Established Names in 
Promotional Materials.''
    c. Broadcast advertisement issues will be addressed in 2.B.4, 
``Prominence of Risk Information in Broadcast Advertisements.''
    d. Issues related to comparative claims will be addressed in 2.A.1, 
``Comparative Promotional Materials.''
    e. Direct-to-consumer promotion issues will be be reconsidered in 
3.2, ``Direct-to-Consumer Promotion.''
    f. Fair balance issues will be addressed in 2.B.1, ``Fair 
Balance.''

[[Page 14916]]

    g. Issues related to formulary kits will be addressed in 2.A.2, 
``Formulary Kits as Promotional Labeling.''
    h. Issues related to generic drug advertisements will be addressed 
in 2.A.3, ``Generic Drug Promotional Labeling and Advertising.''
    i. Issues related to unsolicited information will be addressed in 
2.A.8, ``Solicited and Unsolicited Requests for Information.''
    j. Wrap-around advertisement issues will be addressed in 2.B.5, 
``Wrap-Around Advertisements.''
    k. Issues related to ``Data on file'' references will be addressed 
in 2.C.1, ``Data on File and Foreign Language Publications 
References.''
    52. Letter dated September 1994--This letter for anti-infective 
drug product manufacturers addressed several advertising claims 
including the use of in vitro data, comparative claims, cost-
effectiveness claims, presentation of indications, and use of 
pharmacokinetic data. This guidance will be revised and combined with 
the March 18, 1971, December 20, 1984, and February 27, 1986, guidances 
in this list concerning antibiotic promotion to create 2.D.2, ``Anti-
infective Drug Products.''

II. List 2--Guidances That Address Current Issues, But Require 
Revision

    List 2 contains guidance documents that will be revised and 
reissued as part of DDMAC's review of its prescription drug advertising 
and labeling guidances. Documents mentioned in List 1 are referenced. 
For example, 1.51, refers to List 1, document 51, the April 1994 
guidance entitled ``Current Issues and Procedures.'' To simplify their 
presentation, guidances in List 2 have been grouped into the following 
general topics: A--Content of Promotional Materials; B--Format of 
Promotional Materials; C--Procedures for Interacting with DDMAC; and 
D--Issues Related to Product or Class. In some cases, a guidance may 
address issues under more than one topic. Guidances are listed in 
alphabetical order under each topic.

A. Content of Promotional Materials

    1. ``Comparative Promotional Materials''--This guidance to industry 
will combine and revise 1.15, 1.35, 1.48, and 1.51.d. These guidances 
discussed comparative promotional claims for a variety of drug 
products.
    2. ``Formulary Kits as Promotional Labeling''--This guidance to 
industry will revise 1.51.g, which discusses formulary kits as 
labeling. The revised guidance will also be considered in 3.7, a 
guidance being developed regarding promotion to managed care 
organizations.
    3. ``Generic Drug Promotional Labeling and Advertising''--This 
guidance to industry will be based on the pertinent subject in 1.51.h. 
The guidance will explain the use of the terms ``AB rated'' and 
``bioequivalent'' in promotional materials and price catalogs.
    4. ``Institutional and Help-Seeking Advertisements''--This guidance 
to industry will be based on appropriate parts of 1.27 and 1.34. It 
will combine the concepts of institutional and disease-oriented 
advertising, especially as they pertain to consumers.
    5. ``Print and Video News Releases''--This guidance to industry 
will combine and revise 1.10 and 1.38 to address under what 
circumstances press kits, new releases, and video news releases will be 
considered labeling.
    6. ``Scientific and Educational Materials--Criteria For 
Independence''--This guidance to industry will combine 1.4 and 1.5. The 
guidance will discuss the criteria to be considered when judging the 
independence of scientific and educational publications, materials, and 
programs for determination of labeling status.
    7. ``Single-Sponsored Publications--Criteria for Independence''--
This guidance to industry will revise 1.11 to address when sole-
sponsored publications will not be considered labeling.
    8. ``Solicited and Unsolicited Requests for Information''--This 
guidance to industry will revise 1.14 and 1.51.i to address when 
distribution of product information by or on behalf of the drug sponsor 
will not be considered labeling.
    9. ``Telephone Advertisements''--This guidance to industry will 
revise 1.47 concerning telephone advertisements. The guidance will 
address telephone advertisements and the regulations for broadcast 
advertising.

B. Format of Promotional Materials

    1. ``Fair Balance''--This guidance to industry will revise the 
pertinent part of 1.51.f. The guidance will discuss the placement and 
relative prominence of fair balance information.
    2. ``Overprinting of Images or Promotional Phrases''--This guidance 
to industry will be based on 1.28, which discusses the use of printing 
images or promotional phrases over the brief summary.
    3. ``Placement of Brand and Established Names in Promotional 
Materials''--This guidance to industry will revise the part of 1.51.b 
that addresses issues related to type size and intervening matter 
between the brand and established names, as discussed in the 
regulations.
    4. ``Prominence of Risk Information in Broadcast Advertisements''--
This guidance to industry will revise the pertinent part of 1.51.c. The 
guidance will discuss graphics, sound effects, voice-overs, etc., that 
occur during the presentation of risk information in broadcast 
advertisements and that obscure or detract from risk information.
    5. ``Wrap-Around Advertisements''--This guidance to industry will 
revise the pertinent part of 1.51.j regarding advertisements to be used 
on the front and back covers of a publication.

C. Procedures for Interacting with DDMAC

    1. ``Data on File and Foreign Language Publications References''--
This guidance to industry will revise the pertinent parts of 1.45.c and 
1.51.k regarding how to submit these reference materials to the agency.
    2. ``Filing Requirements and Other Communication for Advertising 
and Labeling''--This guidance to industry will revise the pertinent 
parts of 1.45.a, 1.45.b, and 1.45.e regarding how and where to file 
advertising and labeling pieces.
    3. ``Preapproval Promotion''--This guidance to industry will 
combine and revise 1.34, 1.50, and 1.51.a. The guidance will address 
methods for regulated companies to provide certain information about 
their products prior to approval.
    4. ``Prepublication Review of Promotional Materials''--This 
guidance to industry will combine and revise previous documents that 
addressed prepublication review of launch campaign materials and other 
promotional materials. The guidances that will be combined and revised 
include 1.45.f, 1.46, and 1.49.

D. Issues Related to Product or Class

    1. ``Aerosol Steroid Safety Information''--This guidance to 
industry will revise 1.41, and will advise manufacturers of aerosol 
inhalation steroid products to use a caution statement in promotion.
    2. ``Anti-infective Drug Products''--This guidance to industry will 
combine and revise 1.2, 1.24, 1.29, and 1.52 and include new issues in 
antibiotic promotion.
    3. ``Ionic and Nonionic Contrast Media''--This guidance to industry 
will be based on 1.42, dated June 22, 1992, outlining certain claims 
for ionic and nonionic contrast media made by or on behalf of the drug 
sponsor that are used

[[Page 14917]]

to differentiate products, but that will no longer be acceptable 
without data substantiating the claim.
    4. ``Oral Contraceptive Products--Differentiation Claims''--This 
guidance to industry will combine and revise 1.1, 1.37, and 1.39 
regarding promotional claims that attempt to differentiate oral 
contraceptive products.
    5. ``Transdermal Nicotine Products''--This guidance to industry 
will combine and revise 1.40 and 1.43 regarding the appropriate 
characterization of nicotine products and their use for smoking 
cessation.
    6. ``Transdermal Nitroglycerin Products''--This guidance to 
industry will be based on 1.21 regarding the wording to be used in the 
boxed warnings for these products.

III. List 3--Currently Proposed Guidance Documents and Suggestions 
for New Guidances That DDMAC Should Develop

    List 3 of this document contains proposed topics that are, or may 
be, the subject of future DDMAC guidance documents. An important 
component of public comment consists of the public's suggestions for 
when guidance is needed and what the agency's priorities should be. 
DDMAC therefore welcomes: (1) Comments on the topics listed below, (2) 
requests for additional topics for guidance related to prescription 
drug advertising and promotional labeling, and (3) comments on the 
order in which the topics should be addressed. Once comments have been 
received, guidance documents will be developed as agency resources 
permit. When guidance documents become available for public review and 
comment, the agency will announce their availability in the Federal 
Register. The following proposed topics are listed in alphabetical 
order:
    1. ``Accelerated Approval''--FDA intends to develop a guidance on 
the submission of promotional materials for products approved under 
subpart H of 21 CFR part 314. (See Sec. 314.550, Promotional 
Materials.)
    2. ``Direct-to-Consumer Promotion''--FDA is developing a guidance 
to industry on direct-to-consumer promotion of regulated products. FDA 
held a public hearing and sought written public comment on this topic 
in 1995. In the Federal Register of May 14, 1996 (61 FR 24314), FDA 
published a document on one issue pertaining to direct-to-consumer 
promotion and requested comments to clarify certain other issues. The 
comment period closed August 12, 1996.
    3. ``Drug Product Promotion at International Meetings Held in the 
United States''--FDA is developing a guidance to industry to address 
issues regarding drug product promotion at international meetings held 
in the United States.
    4. ``Infomercial''--FDA is considering the development of a 
guidance to industry concerning television infomercials.
    5. ``Information About Investigational Drugs''--FDA is developing 
guidance on 21 CFR 312.7 regarding the dissemination of press releases 
by sponsors, or on their behalf, containing information concerning 
investigational drugs.
    6. ``Promotion on the Internet''--FDA is identifying issues to be 
addressed in a guidance document about this new promotional medium. FDA 
held a public meeting on this issue on October 16 and 17, 1996, and 
also sought written comments. This meeting was announced in the Federal 
Register of September 16, 1996 (61 FR 48707).
    7. ``Promotion to Managed Care Organizations''--FDA is developing a 
guidance to industry regarding marketing, pharmacoeconomic claims, and 
information exchange in managed care environments. FDA held a public 
hearing and sought written public comment on this in 1995.

    Dated: March 21, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7911 Filed 3-27-97; 8:45 am]
BILLING CODE 4160-01-F


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