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))
14918 Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices

Pharmaceutical equivalents and

pharmaceutical alternatives are defined

similarly in the Orange Book. Under

these definitions, a tablet and a capsule

cannot be rated as therapeutic

equivalents in the Orange Book even if

they have been demonstrated to be

bioequivalent.

FDA has received two citizen

petitions asking the agency to revise the

current policy that does not permit

tablets and capsules to be rated as

therapeutically equivalent. Kleinfeld,

Kaplan and Becker (Kaplan) submitted a

petition dated August 11, 1995, that

asks FDA to take the following actions:

(1) Revise the Orange Book to specify

therapeutic equivalence evaluations for

products that contain the same active

ingredient, but are in a different solid

oral dosage form (i.e., tablets and

capsules); (2) change the Orange Book

designations ‘‘Tablet, Oral’’ and

‘‘Capsule, Oral,’’ to ‘‘Solid, Oral’’; and

(3) change the definitions of

‘‘Pharmaceutical equivalents’’ and

‘‘Pharmaceutical alternatives’’ in FDA’s

regulations in 21 CFR 320.1(c) and (d)

and in the Orange Book to accommodate

the requested changes. The petition

suggests, as an alternative, that FDA

could rule that tablets and capsules are

the same dosage form (i.e., solid oral)

and are thus pharmaceutical

equivalents. Under the latter approach,

grant of a suitability petition (under

section 505(j)(2)(C) of the act (21 U.S.C.

355(j)(2)(C)) and 21 CFR 314.93) would

not be a prerequisite for FDA to approve

a tablet form of a capsule product, or

vice versa.

The National Association of

Pharmaceutical Manufacturers (NAPM)

submitted a citizen petition dated

August 27, 1996, requesting that ‘‘FDA

deem all solid oral dosage form drug

products (e.g., tablets and capsules) as

the same dosage form, which, upon a

showing of bioequivalence, will be

considered in all respects to be

‘pharmaceutical equivalents.’’’ NAPM

argues that tablets and capsules are

‘‘more properly regarded as a single

dosage form, i.e., solid oral dosage

forms.’’ Both petitions assert that there

is no scientific basis for distinguishing

between tablets and capsules that have

been demonstrated to be bioequivalent.

Recently, the issue of whether tablets

and capsules can be listed in the Orange

Book as therapeutically equivalent has

taken on added significance. Some

innovator firms, whose period of

marketing protection (either through

patent or exclusivity) is about to expire,

have succeeded in delaying generic

competition by, for example, voluntarily

withdrawing the new drug application

(NDA) for the tablet formulation of a

product and submitting a second NDA

for the drug product in capsule form. In

such a case, if there are already filed

abbreviated new drug applications

(ANDA’s) for the tablet product, these

ANDA’s cannot be approved

immediately upon expiration of the

innovator’s period of market protection.

Before these ANDA’s can be approved,

an interested party must file a petition

asking the agency to determine whether

the innovator product was withdrawn

for reasons of safety or effectiveness.

The agency must then determine that

the product was not withdrawn for

these reasons, publish that

determination, and relist the product in

the Orange Book. Even after a

withdrawn product has been relisted in

this way, generic competition may still

be affected. For example, if physicians

continue to write prescriptions by brand

name rather than by generic name,

substitution of the generic tablet for the

brand name capsule may not be

permitted under the applicable State

drug product selection statute.

FDA is soliciting public comment on

the two citizen petitions discussed

above. Among the questions the agency

would particularly like to see addressed

are the following:

1. Should any potential change in

current FDA policy be limited to

permitting bioequivalent tablets and

capsules to be listed as therapeutic

equivalents in the Orange Book, or

should FDA regard tablets and capsules

as the same (i.e., solid oral) dosage

form?

2. What would be the implications of

regarding all tablets and capsules as the

same dosage form?

3. Is there a sound scientific basis for

the current distinction between tablets

and capsules?

4. What would be the impact on

patients of rating bioequivalent tablets

and capsules as therapeutically

equivalent, or of adopting the term

‘‘solid oral’’ as a dosage form? Are there

reasons for some patients or health care

practitioners to prefer either tablets or

capsules?

5. How would listing tablets and

capsules as therapeutic equivalents in

the Orange Book affect current

substitution practices under State drug

product selection statutes? What would

be the impact on drug selection by

formularies?

6. What would be the economic

impact of various proposed changes?

7. How would FDA action in this area

relate to United States Pharmacopoeia

(USP) monographs?

Interested persons may, on or before

June 26, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments are to be identified with the

docket numbers found in brackets in the

heading of this document. The NAPM

and Kaplan petitions and received

comments may be seen in the office

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

Monday through Friday. Copies of the

citizen petitions may be requested in

writing from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857.

Dated: March 21, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7912 Filed 3–27–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

(1965, 2649, 5011A–U6, 5011B–U6)

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for

Hearing—Part B Medicare Claim, 42

CFR 405.821; Form No.: HCFA–1965;

Use: Section 1869 of the Social Security

Act authorizes a hearing for any

individual who is dissatisfied with any

determination and amount of benefit

paid. This form is used so that a party

may request a hearing by a Hearing

Officer because the review