Prominence of Name of Distributor of Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. 95N-0295]

Prominence of Name of Distributor of Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the

labeling regulations for biological products to remove the requirement

that the manufacturer's name be more prominent than that of the

distributor and to permit the names of distributors to be prominently

displayed on biological product container labels, package labels, and

labeling. This change in labeling requirements is intended to

facilitate flexible manufacturing, packaging, distribution, and

labeling arrangements, and to harmonize labeling regulations applicable

to biologic products licensed under the Public Health Service Act (the

PHS Act) with the corresponding labeling regulations for drugs approved

under the Federal Food, Drug, and Cosmetic Act (the act).

EFFECTIVE DATE: November 18, 1996.

FOR FURTHER INFORMATION CONTACT: Gloria J. Hicks, Center for Biologics

Evaluation and Research (HFM-630), Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of September 27, 1995 (60 FR 49811), FDA

published a proposed rule to amend the labeling regulations to remove

the requirement that the manufacturer's name be more prominent than the

distributor's and to permit the names of distributors to be prominently

displayed on licensed biological product container labels, package

labels, and labeling. This final rule is being issued in accordance

with the principles set forth in Executive Order 12866 and the

Regulatory Reinvention Initiative announced in President Clinton's

memorandum of March 4, 1995. Executive Order 12866 directs Federal

agencies and the Office of Information and Regulatory Affairs to

implement measures that will reform and streamline the regulatory

process. As part of the Regulatory Reinvention Initiative, a report

entitled ``Reinventing Drug and Medical Device Regulations'' was issued

in April 1995 by the President and Vice President. This final rule

completes a commitment made by FDA in that report to permit greater

flexibility in the appearance of distributors' names on biological

product container labeling, package labels, and labeling.

Under Executive Order 12866, FDA published a notice in the Federal

Register of January 20, 1994 (59 FR 3043), announcing FDA's plan to

review and evaluate all significant regulations for their effectiveness

in achieving public health goals and in order to reduce or eliminate

unnecessary regulatory burden. In the Federal Register of June 3, 1994

(59 FR 28821 and 28822, respectively), FDA published two notices

announcing the review and evaluation of certain biologic and blood and

blood product regulations by the Center for Biologics Evaluation and

Research (CBER). The intent of the review and evaluation was to

identify those regulations that are outdated, burdensome, inefficient,

duplicative, or otherwise unsuitable or unnecessary. Interested persons

were given until August 17, 1994, to respond to the notices by

submitting written comments to the Dockets Management Branch. In the

Federal Register of August 17, 1994 (59 FR 42193), FDA extended the

comment periods to November 15, 1994, in response to requests to allow

for additional time for public comment. In the Federal Register of

November 14, 1994 (59 FR 56448), FDA extended the comment periods to

February 13, 1995, in response to requests to hold a public meeting

regarding the biologics regulations under review.

FDA held a public meeting on January 26, 1995, that was announced

in the Federal Register of January 9, 1995 (60 FR 2351). The notice of

public meeting indicated that the public comment period was to close on

February 13, 1995. The public meeting was a forum for the public to

voice their comments regarding the review and evaluation of regulations

being undertaken by CBER.

Some of the comments from the docket and public meeting questioned

the need for the manufacturer's name to be the most prominent name on

the label of a licensed biological product. FDA's regulation addressing

the name of the selling agent or distributor on biological product

labeling (Sec. 610.64 (21 CFR 610.64)) required that the name of the

manufacturer of the biological product be more prominently displayed on

the label than the name of the selling agent or distributor. These

comments requested that CBER consider revising the labeling regulations

so that developers of innovative new products could place their names

prominently on the label, even if they contract out the manufacturing

of the product. In response to the comments, FDA published a proposed

rule (60 FR 49811) to amend the labeling regulations to permit the

names of distributors to be prominently displayed on biological product

container labels, package labels, and labeling.

II. Highlights of the Final Rule

The final rule is intended to facilitate flexible manufacturing,

packaging, distribution, and labeling arrangements. FDA recognizes that

small innovator firms may not have the facilities to manufacture

commercial quantities of a biological product. Such innovator firms

that do not hold the license for the product will no longer be required

to feature the license holder's name more prominently on the label.

Manufacturers and distributors will have the option to

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negotiate with each other for the prominence of the various firm names

on the label.

The final rule is also intended to reduce the regulatory burden on

manufacturers who produce both biologics and other drugs by harmonizing

this labeling requirement with the labeling provisions in Sec. 201.1

(21 CFR 201.1) applicable to drugs approved under the act.

The final rule removes the requirement that the manufacturer's name

be more prominent than the distributor's name on product labeling. The

final rule prescribes a number of options for identifying the

distributor so that the information on the label is consistent with the

actual circumstances of the sale and distribution of the product. In

cases where a distributor is named on the label, the final rule

requires the use of a qualifying phrase to distinguish the manufacturer

and distributor of the product. The requirements that the name,

address, and license number of the manufacturer also appear on the

container label (21 CFR 610.60) and package label (21 CFR 610.61)

remain unchanged.

III. Comments on the Proposed Rule and FDA Responses

FDA received five letters of comments on the proposed rule. All of

the letters were from biological product manufacturers and

distributors. All letters favored the proposed rule. Two comments

requested that the proposed rule be broadened to further harmonize the

biologics labeling regulations with requirements applicable to drugs

approved under the act. One comment requested clarification of the

proposed rule.

1. One comment requested that FDA completely harmonize Sec. 610.64

with Sec. 201.1 regarding appearance of the manufacturer's name and

address. The comment stated that FDA's proposal to retain the

requirement that the manufacturer's name and address appear on the

label of a biologic product imposes regulatory burden on manufacturers

who produce both biological products and drugs approved under the act,

as there is no such corresponding requirement for drugs subject to

Sec. 201.1.

FDA agrees that harmonizing the labeling requirements applicable to

biological products with those applicable to drugs approved under the

act is desirable, where appropriate. The PHS Act, section 351(a),

requires that each package of a biological product subject to licensure

be plainly marked with the name, address, and license number of the

manufacturer. The agency believes that the provision in this final rule

that the manufacturer's name, address, and license number must appear

on the label of a biological product is a reasonable approach to

address the statutory requirement. However, as part of the May 14, 1996

(61 FR 24227), final rule to eliminate the establishment license

application requirement for specified biotechnology and specified

synthetic biological products licensed under the PHS Act, FDA has

broadened the definition of ``manufacturer'' in 21 CFR 600.3(t) to

provide greater flexibility in determining who may hold a license, and

consequently, who would be identified as the ``manufacturer'' in

labeling.

2. A second comment requested that FDA clarify whether the deletion

of the requirement that a distributor's name be less prominent than the

manufacturer's name would apply to promotional labeling.

While the final rule applies by its terms to the ``label'' on a

biological product and does not specifically address promotional

labeling, FDA intends to apply a similar policy in its review of

promotional labeling.

3. A third comment asked that consideration be given to allowing

the product trademark or logo to appear on the labeling in larger type

than the product name.

The requirement that the proper name be at least as prominent as

the trademark and trade name is included in 21 CFR 610.62. Labeling

requirements other than in Sec. 610.64 are not addressed in this

rulemaking. In the Federal Register of June 3, 1994 (58 FR 28821), FDA

announced that it was undertaking the review of the general biologics

and licensing regulations, including labeling regulations. FDA will

consider the comment regarding the prominence of the product trademark

or logo as part of the general review of the regulations.

FDA has considered all comments received in response to the

proposed rule and has determined that the proposed rule should be

issued as a final rule. Accordingly, FDA is issuing as a final rule a

revised Sec. 610.64 to provide greater flexibility in displaying the

prominence of the name of a product distributor on the product label.

IV. Effective Date

The final rule is effective November 18, 1996. As provided under 5

U.S.C. 553(d) and Sec. 10.40(c)(4) (21 CFR 10.40(c)(4)), the effective

date of a final rule may not be less than 30 days after date of

publication, except for, among other things, ``a regulation that grants

an exemption or relieves a restriction'' (Sec. 10.40(c)(4)(i)).

Because, as described in section V. of this document, this final rule

will provide greater flexibility in labeling to manufacturers and

distributors of biological products, FDA believes that an effective

date shorter than 30 days is appropriate.

V. Analysis of Impacts

FDA has examined the impact of the final rule under Executive Order

12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive

Order 12866 directs agencies to assess all costs and benefits of

available regulatory alternatives and, when regulation is necessary, to

select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impact; and equity). The agency believes that

this final rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the final

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

Under the Regulatory Flexibility Act, FDA must analyze regulatory

options that would minimize any significant economic impact of the rule

on small entities. This amendment provides labeling alternatives by

allowing the names of distributors to be as (or more, or less)

prominent than names of manufacturer(s) on the label. It does not

require any entity to change its current procedures. At this time FDA

cannot quantify the benefits of the rule, although it may benefit

manufacturers or distributors by allowing greater flexibility in

labeling. Therefore, under the Regulatory Flexibility Act (5 U.S.C.

605(b)), FDA certifies that this rule will not have a significant

economic impact on a substantial number of small entities, and no

further analysis is required.

VI. Environmental Impact

The agency has determined under 21 CFR 25.24(c)(10) that this

action is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

Lists of Subjects in 21 CFR Part 610

Biologics, Labeling, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act, the

Public Health Service Act, and under authority

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delegated to the Commissioner of Food and Drugs, 21 CFR part 610 is

amended as follows:

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

1. The authority citation for 21 CFR part 610 continues to read as

follows:

Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health

Service Act (41 U.S.C. 216, 262, 263, 263a, 264).

2. Section 610.64 is revised to read as follows:

Sec. 610.64 Name and address of distributor.

The name and address of the distributor of a product may appear on

the label provided that the name, address, and license number of the

manufacturer also appears on the label and the name of the distributor

is qualified by one of the following phrases: ``Manufactured

for______________'', ``Distributed by ____________'', ``Manufactured by

__________ for __________'', ``Manufactured for __________ by

________'', ``Distributor: __________'', or ``Marketed by __________''.

The qualifying phrases may be abbreviated.

Dated: October 28, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96-28530 Filed 11-5-96; 8:45 am]

BILLING CODE 4160-01-F