14912 Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices

forward a copy of each comment to the

Dockets Management Branch (address

above). Received comments may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: March 20, 1997.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 97–7836 Filed 3–27–97; 8:45 am]

BILLING CODE 4160–01–F

[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.

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:

‘‘moncavage@cder.fda.gov.’’

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
Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices 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 crossreferenced 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 solesponsored 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, ‘‘SingleSponsored 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
14914 Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices

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 lessthan-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, ‘‘Antiinfective 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, ‘‘Antiinfective 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
Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices 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 doubleboxed 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-toConsumer 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.’’
14916 Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices

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, ‘‘WrapAround 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
Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices 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 § 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

[Docket Nos. 95P–0262 and 96P–0317]

Citizen Petitions Concerning

Therapeutic Equivalency Ratings

Between Tablets and Capsules;

Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

comments on two citizen petitions that

ask the agency to revise its current

policy concerning therapeutic

equivalency ratings between tablets and

capsules. The petitions propose that a

tablet and a capsule containing the same

active ingredient in the same dosage

strength that have been demonstrated to

be bioequivalent be listed as therapeutic

equivalents in the publication

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations.’’

FDA is seeking public comment in order

to assist the agency in deciding whether

to revise its current policy.

DATES: Submit written comments by

June 26, 1997.

ADDRESSES: Written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Christine F. Rogers, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

5644.

SUPPLEMENTARY INFORMATION: The

publication ‘‘Approved Drug Products

with Therapeutic Equivalence

Evaluations’’ (the Orange Book)

identifies drug products approved on

the basis of safety and effectiveness by

FDA under the Federal Food, Drug, and

Cosmetic Act. The Orange Book also

contains therapeutic equivalence

evaluations for approved multisource

prescription drug products. These

evaluations are prepared to serve as

public information and advice to State

health agencies, prescribers, and

pharmacists, to promote public

education in the area of drug product

selection, and to foster containment of

health costs.

For two drug products to be listed as

therapeutically equivalent in the Orange

Book, the products, among other

criteria, must be pharmaceutical

equivalents. FDA regulations define

pharmaceutical equivalents as follows:

Pharmaceutical equivalents means drug

products that contain identical amounts of

the identical active drug ingredient, i.e., the

same salt or ester of the same therapeutic

moiety, in identical dosage forms, but not

necessarily containing the same inactive

ingredients, and that meet the identical

compendial or other applicable standard of

identity, strength, quality, and purity,

including potency and, where applicable,

content uniformity, disintegration times and/

or dissolution rates.

(see 21 CFR 320.1(c))

Tablets and capsules containing the

same active ingredient in the same

dosage strength are defined as

pharmaceutical alternatives rather than

pharmaceutical equivalents.

Pharmaceutical alternatives are defined

as follows:

Pharmaceutical alternatives means drug

products that contain the identical

therapeutic moiety, or its precursor, but not

necessarily in the same amount or dosage

form or as the same salt or ester. Each such

drug product individually meets either the

identical or its own respective compendial or

other applicable standard of identity,

strength, quality, and purity, including

potency and, where applicable, content

uniformity, disintegration times and/or

dissolution rates.

(see 21 CFR 320.1(d))