[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:
``[email protected].''
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