64074 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92N–0434]

Final Guidance on Industry-Supported

Scientific and Educational Activities

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

final guidance entitled ‘‘Final Guidance

on Industry-Supported Scientific and

Educational Activities’’ (hereinafter

referred to as the final guidance). The

agency sought public comment on a

draft version of this final guidance

entitled ‘‘Draft Policy Statement on

Industry-Supported Scientific and

Educational Activities’’ (hereinafter

referred to as the draft policy statement),

which was published in the Federal

Register on November 27, 1992; and on

November 18, 1994, on a related citizen

petition. The agency considered the

comments received and, where

appropriate, revised the draft policy

statement to create the final guidance.

The final guidance describes how

industry may support scientific and

educational activities without being

subject to regulation under the Federal

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

The full text of the guidance is

published in this document.

DATES: Written comments on the

guidance may be submitted at any time.

ADDRESSES: Submit 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:

For general questions about the

guidance: Ilisa B. G. Bernstein,

Office of Policy (HF–23), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

827–3380, or via e-mail at

IBernste@oc.fda.gov;

Regarding biological products: Toni

M. Stifano, Center for Biologics

Evaluation and Research (HFM–

200), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–827–3028, or via e-mail at

stifano@cber.fda.gov;

Regarding medical device products:

Byron L. Tart, Center for Device

Evaluation and Radiologic Health

(HFZ–302), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–

4639, or via e-mail at

bxt@cdrh.fda.gov;

Regarding human prescription drugs:

Norman A. Drezin, Center for Drug

Evaluation and Research (HFD–40),

Food and Drug Administration,

5600 Fishers Lane, rm. 17B–17,

Rockville, MD 20857, 301–827–

2831, or via e-mail at

drezinn@cder.fda.gov;

Regarding prescription animal drugs:

Edward L. Spenser, Center for

Veterinary Medicine (HFV–216),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–594–1722, or via e-mail

at espenser@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 27, 1992

(57 FR 56412), FDA published the draft

policy statement. As the agency noted in

the introduction to the draft policy

statement, these activities may be

subject to regulation under the labeling

and advertising provisions of the act

when they provide information on FDAregulated products marketed by the

supporting companies.

As the introduction also noted, FDA

traditionally has not sought to regulate

industry-supported scientific and

educational activities that are otherwise

independent and nonpromotional.

Industry-supported scientific and

educational activities that are not

independent and nonpromotional are

not per se illegal, but they are subject to

regulation.

FDA published the draft policy

statement in response to requests from

industry for guidance in this area. Prior

to publishing the draft policy statement,

the agency engaged in an extensive

outreach effort with scientific and

health care professionals, industry,

consumer groups, and other

Government agencies in an attempt to

strike a proper balance between the

need for industry-supported

dissemination of current scientific

information and the need to ensure that

promotional activities by industry meet

the requirements of the law.

Recognizing the importance and

delicacy of this balance, the agency

invited comments with regard to all

issues raised in the draft policy

statement.

The agency received 152 comments,

which included comments from

academic and organized medicine,

health care professionals, industry and

trade associations, public relations and

advertising firms, and commercial

continuing education providers. FDA

thoroughly considered these comments

and revised the draft policy statement

where appropriate. In the Federal

Register of November 18, 1994 (59 FR

59820), the agency sought comment on

a citizen petition (Docket No. 92N–

0434/CP1) requesting that the agency

withdraw the draft policy statement.

The agency received about 60 comments

in response to this notice.

I. Highlights of the Final Guidance

In response to comments, the agency

has made several revisions to the draft

policy statement. First, the draft policy

statement has been modified to clarify

that it is providing guidance on what

the agency would look at in determining

independence. In doing so, rather than

enumerating the elements of a written

agreement, the final guidance presents

the ideas contained in the elements as

factors the agency will consider in

evaluating activities and determining

independence. Additionally, the text of

‘‘Other Factors in Determining

Independence’’ indicia that were listed

in section II.B. of the draft policy

statement (57 FR 56412 at 56414) are

now included in the factors the agency

will consider in evaluating activities

and determining independence. Second,

although the final guidance has been

modified to place less emphasis on a

written agreement between the

supporting company and the provider,

the agency continues to believe that a

written agreement is one way to

document what measures were taken by

the parties to maintain the

independence of the program.

In the final guidance, only 1 of the 10

elements of the written agreement

presented in the draft policy statement

remains unchanged. The ‘‘Statement of

Purpose’’ (section II.A.1. of the draft

policy statement) has been deleted

because the final guidance lists the

factors the agency will consider, rather

than a suggested written agreement. The

text of the ‘‘Control of Content and

Selection of Presenters and Moderators’’

(section II.A.2. of the draft policy

statement) has been modified slightly,

but remains substantially unchanged. In

the ‘‘Disclosure of Financial

Relationships’’ (section II.A.3. of the

draft policy statement) a factor has been

added indicating that when an activity

includes discussion of unapproved uses,

there should be general disclosure of

that fact. Additionally this discussion

has been renamed ‘‘Disclosures,’’ and all

factors that describe a disclosure are

listed under this heading. The

discussion concerning ‘‘Supporting

Company Involvement in Content’’

(section II.A.4. of the draft policy

statement) has been incorporated into

the factor concerning ‘‘Control of

Content and Selection of Presenters and

Moderators’’ of the final guidance. The
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64075

discussion of ‘‘Ancillary Promotional

Activities’’ (section II.A.5. of the draft

policy statement) has been narrowed so

as to limit promotional activities only in

the room in which an activity takes

place. The discussions concerning

‘‘Objectivity and Balance’’ (section

II.A.6.), ‘‘Limitations on Data’’ (section

II.A.7. of the draft policy statement), and

‘‘Discussion of Unapproved Uses’’

(section II.A.8. of the draft policy

statement) have been deleted from the

final guidance. The ‘‘Opportunities for

Debate’’ (section II.A.9. of the draft

policy statement) has been renamed

‘‘Opportunities for Discussion’’ to

clarify its intent. The ‘‘Schedule of

Activities’’ discussion (section II.A.10.

of the draft policy statement) has also

been deleted from the final guidance.

Much of the draft policy statement’s

section entitled ‘‘Other Factors in

Determining Independence’’ appears in

the final guidance, with a few

modifications. First, the discussions

concerning the ‘‘Provider’’ (section

II.B.1. of the draft policy statement) has

been modified slightly, deleting the

statement that discussed whether

persons who are involved in promotion

of a company’s products may function

in the role as an independent provider.

The discussion concerning industry

representatives help in logistical

assistance (section II.B.2.a. of the draft

policy statement) has been deleted from

final guidance. The ‘‘Suggestion of

Presenters’’ discussion (section II.B.2.b.

of the draft policy statement) has been

incorporated, in part, into the factor

concerning ‘‘Control and Content and

Selection of Presenters and Moderators’’

in the final guidance. The discussion

concerning ‘‘Focus on a Single Product’’

(section II.B.3.a. of the draft policy

statement) has been incorporated into

the factor entitled ‘‘Focus of the

Program’’ in the final guidance. The

discussions concerning ‘‘Multiple

Performances’’ (section II.B.3.b. of the

draft policy statement), ‘‘Audience

Selection’’ (section II.B.4.c.),

‘‘Dissemination’’ (section II.B.5.), and

‘‘Complaints’’ (section II.B.6.) remain

substantially unchanged. The ‘‘Gifts’’

(section II.B.4.a.) and ‘‘Emphasis on

Noneducational Activities’’ (section

II.B.4.b.) discussions have been deleted

from the final guidance. Finally, the

discussion concerning ‘‘Misleading

Title’’ (section II.B.4.d. of the draft

policy statement) has been incorporated

into the factor concerning ‘‘Focus of the

Program’’ in the final guidance.

In general, these revisions are

intended to better focus the final

guidance on the agency’s core

concerns—that the provider develop the

subject program independent from the

influence of the supporting company,

and that there is disclosure of

relationships between and among the

supporting company, provider,

presenters, and products discussed that

may be relevant to an assessment of the

information presented. Thus, while the

number of changes may be significant,

they do not change the fundamental

intent of the final guidance to

distinguish industry-supported

scientific and educational activities that

are free from supporting company

influence from those that are not.

II. Summary and Responses to

Comments Received

A. General Comments

1. Several comments disputed the

agency’s assertion that industrysupported scientific and educational

activities traditionally have been viewed

by the agency as subject to regulation

under the act. They maintained that

regulation of these activities is an

unwarranted expansion of agency

authority and that the agency should

specifically articulate the basis for its

regulatory authority.

FDA has long regulated drugs and

devices (including biological products

and animal drugs) based on the

‘‘intended uses’’ for such products.

Under section 201 of the act (21 U.S.C.

321), which defines the terms ‘‘drug’’

and ‘‘device,’’ the intended use of an

article determines whether the article is

a drug or device. In general, under the

act and the Public Health Service Act,

a sponsor who wishes to market any

new drug or biological product must

demonstrate to FDA that the product is

safe and effective for each of its

intended uses. (See sections 505(a) and

512(a) of the act (21 U.S.C. 355(a) and

360b(a)) and section 351 of the Public

Health Service Act.) A sponsor who

wishes to market a new medical device

must either demonstrate to FDA that

there is a reasonable assurance that the

device is safe and effective for each of

its intended uses or that it is

substantially equivalent to (meaning, in

part, that it has the same intended use

as) another device for which such a

showing is not required. (See sections

510(k), 513(f) and (i), and 515(a) of the

act (21 U.S.C. 360(k), 360c(f) and (i), and

360e(a)).) The package insert or product

manual (approved professional labeling)

which, for approved and/or licensed

products, physically accompanies the

product, sets forth the uses for which

the product has been demonstrated to be

safe and effective.

The ‘‘intended use’’ of a drug or

device refers to the objective intent of

the persons legally responsible for the

labeling of the product. This intent is

determined by such persons’

expressions or by the circumstances

surrounding the distribution of the

article including, for example, labeling

claims, advertising matter, or oral or

written statements by such persons or

their representatives. (See 21 CFR

201.128 and 801.4.) The agency, thus,

regulates products based not only on

information provided ‘‘with’’ the

product (approved professional

labeling), but also based on information

disseminated by or on behalf of

manufacturers in other contexts, such as

scientific and educational meetings and

symposia, books, reprints of articles

from scientific journals, in part because

all of these activities/materials can

create new intended uses for the

products, which must be reflected in the

approved labeling of the products.

The agency’s focus on the

manufacturer’s characterization of its

product in the marketplace is best

reflected in the statutory requirement

that a drug or device shall be deemed

to be misbranded unless its labeling

bears adequate directions for use. (See

section 502(f)(1) of the act (21 U.S.C.

352(f)(1)).) The courts have agreed with

the agency that section 502(f)(1) of the

act requires information not only on

how a product is to be used (e.g., dosage

and administration), but also on all the

intended uses of the product. (See

Alberty Food Products Co. v. United

States, 185 F.2d 321 (9th Cir. 1950)

(drug product was misbranded because

its labeling failed to state the intended

use of the drug (arthritis and

rheumatism) as suggested by the

company in newspaper advertisements);

21 CFR 201.5)) As previously described,

oral statements and materials presented

at industry-supported scientific and

educational activities may provide

evidence of a product’s intended use. If

these statements or materials promote a

use that is inconsistent with the

product’s approved labeling, the

product is misbranded under section

502(f)(1) of the act for failure to bear

labeling with adequate directions for all

intended uses. If it is a device, it is also

adulterated because the listing of

unapproved uses in the labeling or

advertising of an approved device

results in an adulterated medical device

under section 501(f) of the act, and

misbranded under section 502(o) of the

act because premarket notification was

not provided as required under section

510(k) of the act.

FDA also finds support for its policy

of examining a broad array of

information disseminated by companies

in the general grant of authority over

labeling and advertisements. Section
64076 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

201(m) of the act defines the term

‘‘labeling’’ to include all ‘‘written,

printed, or graphic’’ materials

‘‘accompanying’’ a regulated product.

The Supreme Court has agreed with the

agency that this definition is not limited

to materials that physically accompany

a product. If the material supplements,

explains, or is otherwise textually

related to a product, it is deemed to

accompany the product for purposes of

section 201(m) of the act. (See Kordel v.

United States, 335 U.S. 345 (1948).)

The agency has adopted a similar

interpretation of the term

‘‘advertisement,’’ which appears in

section 502(n) of the act (prescription

drug advertisements) and 502(r) of the

act (restricted device advertisements).

Although the act does not define the

term ‘‘advertisement,’’ section 502(n)

and (r) of the act indicates that

advertisements do not include materials

regulated as labeling. In addition, the

legislative histories of the 1938 act and

the 1962 amendments to the act support

a broad construction of what constitutes

‘‘advertising.’’ Thus, the agency

interprets the term ‘‘advertisement’’ to

include information (other than

labeling) that originates from the same

source as the product and that is

intended to supplement or explain the

product. Prescription drug and

restricted device advertisements that do

not comply with section 502(n), (q), or

(r) of the act, or regulations issued

thereunder, cause a prescription drug or

restricted device to be misbranded.

2. Some comments contended that the

policy will adversely affect the

availability and quality of continuing

education for health care professionals.

They maintained that the perception of

regulatory risk on the part of supporting

companies, as well as administrative

and financial burdens resulting from

compliance with the policy, will cause

companies that have supported

educational programs to redirect funds

to lower risk, more efficient activities.

The agency recognizes the importance

of continuing education for health care

professionals and recognizes, as well,

the traditional role of industry in

supporting such activities. With this

final guidance, the agency has

attempted to address concerns raised by

supporting companies, to describe

factors the agency will consider in

determining whether an industrysupported activity is independent and

not generally subject to regulation, and

to accommodate industry’s need for

predictability in these activities. The

agency believes that the flexibility

accorded companies in the final

guidance and in the agency’s responses

to these comments should provide a

reasonable basis for continued support

for these activities. Decisions by

companies involving allocation of

resources for promotion and education

are, of course, affected by a variety of

factors. The agency cannot ensure that

companies will provide a given level of

support for professional education

within the health care community.

B. The First Amendment

3. Several comments contended that

the Draft Policy Statement on IndustrySupported Scientific and Educational

Activities (Draft Policy Statement)

infringes upon the First Amendment to

the Constitution. Some comments

claimed that the Draft Policy Statement

infringed protections afforded to

commercial speech.

The agency has considered the First

Amendment in developing its policies

on industry-supported scientific and

educational activities, and believes that

the Draft Policy Statement and the Final

Guidance are consistent with the First

Amendment’s protection of freedom of

expression. In producing these policy

statements (guidance), FDA has sought

to accommodate the need for industrysupported scientific and educational

activities and the statutory mandate to

regulate promotional activities (labeling

and advertising) for drugs and devices

in accordance with the act and the

Public Health Service Act.

1. The Regulation of Drugs and Devices

FDA’s guidance on industrysupported scientific and educational

activities describes the agency’s

regulation of drugs and medical devices;

it is not intended to regulate speech. It

provides insight into the factors FDA

will consider when evaluating an

industry-supported activity to

determine whether it should be subject

to regulation as labeling or advertising,

and, if so, to ensure that the activity

does not misbrand or adulterate the

subject drug or device. There are three

bases for this conclusion.

First, the guidance applies only to

those company-supported activities that

relate to the supporting company’s

product(s) or to competing product(s). A

company-supported activity that does

not relate to the company’s product, a

competing product, or suggest a use for

the company’s product would not be

subject to regulation as a promotional

activity.

Second, the guidance distinguishes

between company-supported activities

that are independent of the promotional

influence of the supporting company

and those that are not. As explained in

the guidance, the agency does not seek

to regulate industry-supported activities

that are independent and

nonpromotional.

Third, the regulation of drugs and

devices has an unavoidable effect on

speech. As explained more fully in

response to Comment A.1, the act

mandates that FDA regulate products as

drugs or devices (including biological

products and animal drugs) based on

the ‘‘intended uses’’ for such products.

Under section 201 of the act which

defines, among other things, the terms

‘‘drug’’ and ‘‘device,’’ the intended use

of an article determines whether the

article is a drug or device. In general,

under the act and the Public Health

Service Act, a sponsor who wishes to

market any new drug or biological

product must demonstrate to FDA that

the product is safe and effective for each

of its intended uses (sections 505(a) and

512(a) of the act and section 351 of the

Public Health Service Act). A sponsor

who wishes to market a new medical

device must either demonstrate to FDA

that there is a reasonable assurance that

the device is safe and effective for each

of its intended uses or that it is

substantially equivalent to (meaning, in

part, that it has the same intended use

as) another device for which such a

showing is not required (sections 510(k),

513(f) and (i), and 515(a) of the act). In

addition, all drugs and devices must

bear labeling with adequate directions

for each intended use. If labeling for a

drug or device fails to contain adequate

directions for each intended use, the

drug or device is deemed to be

misbranded (section 502(f)(1) of the act)

and subject to seizure or other

enforcement actions. For approved or

licensed products, the requirement that

products bear labeling with adequate

directions for use is met by inclusion of

the products’ FDA-approved

professional labeling (package insert or

product manual) that sets forth the uses

for which the product has been

approved/cleared as safe and effective.

The intended use of a drug or device

refers to the objective intent of the

persons legally responsible for the

labeling of the product.

The intent is determined by such persons’

expressions or may be shown by the

circumstances surrounding the distribution

of the article. This objective intent may, for

example, be shown by labeling claims,

advertising matter, or oral or written

statements by such persons or their

representatives.

(21 CFR 201.128 and 801.4) (emphasis

added); see e.g., Coyne Beahm, Inc., et

al. v. United States Food and Drug

Administration, et al., 958 F. Supp.

1060 (M.D.N.C. 1997).

Accordingly, oral statements and

materials presented at industry-
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64077

1Section 201(m) of the act defines the term

‘‘labeling’’ to include all ‘‘written, printed, or

graphic’’ materials ‘‘accompanying’’ a regulated

product. (See Kordel v. United States, 335 U.S. 345,

349–350 (1948).)

2 It is a violation of the act to, among other things,

introduce or deliver for introduction into interstate

commerce a misbranded or adulterated drug or

device, or to cause the misbranding or adulteration

of a drug or device while it is held for sale after

shipment in interstate commerce. (See e.g., sections

301(a) and (k) of the act.)

supported scientific and educational

activities may provide evidence of a

product’s intended use. If these

statements or materials promote a use

that has not been approved by the

agency (and therefore does not appear in

the product’s approved labeling), the

product is misbranded under section

502(f)(1) of the Act for failure to bear

labeling with adequate directions for all

intended uses (21 CFR 201.5; Alberty

Food Products Co. v. United States, 185

F.2d 321 (9th Cir. 1950)). The product

may also be misbranded if its labeling1

or advertising is false or misleading

(section 502(a), (n), and (q) of the act).

If it is a device, it is also adulterated

because the listing of unapproved uses

in the labeling or advertising of an

approved device results in an

adulterated medical device under

section 501(f) of the act, and

misbranded under section 502(o) of the

act because premarket notification was

not provided as required under section

510(k) of the act.2 Thus, FDA’s

regulation of intended uses for drugs

and devices is essential to the regulation

of such products. The safety and

effectiveness of drugs and devices

cannot be evaluated in isolation from

consideration of their intended uses.

The Supreme Court ‘‘has recognized

the strong governmental interest in

certain forms of economic regulation,

even though such regulation may have

an incidental effect on rights of speech

* * *’’ (NAACP v. Claiborne Hardware

Co., 102 S.Ct. 3409, 3425 (1982)). (See

also Ohralik v. Ohio State Bar

Association, 98 S.Ct. 1912, 1919 (1978)

(the government ‘‘does not lose its

power to regulate commercial activity

deemed harmful to the public whenever

speech is a component of that

activity’’).) Similarly, several lower

courts have recognized that in certain

areas of extensive Federal regulation

(securities, antitrust, transportation,

trade, and labor), the Government may

regulate communications of the

regulated parties without offending the

First Amendment. In particular, SEC v.

Wall Street Publishing Institute, Inc.,

851 F.2d 365 (D.C. Cir. 1988), cert.

denied, 109 S.Ct. 1342 (1989), is most

analogous to FDA’s regulation of

industry-supported scientific and

educational activities.

The defendant in Wall Street

Publishing published a stock market

magazine that included feature articles

profiling individual companies and

portraying the subject firms as appealing

investment prospects. Some of the

articles were written by the featured

company itself, others were written by

public relations firms paid by the

featured companies, and still others

were written by the editors of the

magazine, who were paid by the

featured companies. Because these

arrangements were not disclosed in the

magazine, the Securities Exchange

Commission (SEC) sought to enjoin the

publisher for violations of section 17(b)

of the Securities Act of 1993, 15 U.S.C.

77q(b), which makes it unlawful to

describe a security for consideration

without disclosing the existence of the

consideration. The publisher challenged

the injunction on, among others, First

Amendment grounds.

The court rejected the SEC’s

characterization of the feature articles as

commercial speech and upheld the

government’s efforts to regulate the

magazine based on ‘‘the federal

government’s broad powers to regulate

the security industry’’ (Id. at 372

(footnote omitted)). According to the

court, ‘‘[w]here the federal government

extensively regulates a field of economic

activity, communication of the regulated

parties often bears directly on the

particular economic objectives sought

by the government, and regulation of

such communications has been upheld’’

(Id. (citations omitted)). This holding

stems from the fact that ‘‘[i]f speech

employed directly or indirectly to sell

securities were totally protected, any

regulation of the securities market

would be infeasible* * *.’’ (Id. at 373;

see also Id. at 374 n.9 (‘‘Requiring

disclosure of a material fact in order to

prevent investor misunderstanding is

the very essence of federal securities

regulation.’’))

The court noted that:

[R]egulation of the exchange of information

regarding securities is subject only to limited

First Amendment scrutiny. Speech relating to

the purchase and sale of securities, in our

view, forms a distinct category of

communications in which the government’s

power to regulate is at least as broad as with

respect to the general rubric of commercial

speech * * * In areas of extensive federal

regulation * * * we do not believe the

Constitution requires the judiciary to weigh

the relative merits of particular regulatory

objectives that impinge upon

communications occurring within the

umbrella of an overall regulatory scheme.

Id. at 373. See also Home Box Office,

Inc. v. FCC, 567 F.2d 9, 46 (D.C. Cir.

1977), cert. denied, 434 U.S. 829 (1977)

(‘‘[R]ules restricting speech do not

necessarily abridge freedom of

speech.’’); SEC v. Suter, 732 F.2d 1294

(7th Cir. 1984).

As with securities regulation, the

Federal Government exerts extensive

authority over the sale and promotion of

drugs and devices. Moreover, as

previously explained, the Government’s

ability to regulate speech about these

products, like its need to regulate

speech concerning the sale of securities,

is essential to the regulation of drugs

and devices. Yet the regulation of drugs

and devices, unlike the regulation of

securities, clearly encompasses more

than economic activity; it protects

consumer health and safety in an area

where harm to the public can be direct

and immediate.

Accordingly, First Amendment

defenses have been raised and rejected

in a number of FDA enforcement

actions. ‘‘Freedom of speech does not

include the freedom to violate the

labeling provisions of the Federal Food,

Drug, and Cosmetic Act’’ (United States

v. Articles of Food * * * Clover Club

Potato Chips, 67 F.R.D. 419, 424 (D.

Idaho 1975)). The First Amendment

does not prohibit the seizure and

condemnation of a book that is used to

misbrand a product (United States v. 8

Cartons, Containing ‘‘Plantation ’The

Original’ etc. Molasses’’, 103 F. Supp.

626, 628 (W.D.N.Y. 1951); United States

v. Articles of Drug, 32 F.R.D. 32, 35 (S.D.

Ill. 1963); but cf. United States v. 24

Bottles * * *’’Sterling Vinegar and

Honey’’, 338 F.2d 157 (2d Cir. 1964)

(book not used in immediate connection

with sale of product is not labeling and

does not misbrand product)).

In conclusion, the act requires that

FDA regulate drugs and devices based

on their ‘‘intended use.’’ The term

‘‘intended use’’ is broadly defined to

capture the manner in which a company

characterizes its product in the

marketplace. The agency thus must

examine the various means by which

manufacturers and their representatives

provide information about their

products to health care professionals

and consumers, including statements

and materials presented at industrysupported scientific and educational

activities, to determine whether the

products are being improperly

promoted, and therefore misbranded or

adulterated. Accordingly, FDA’s ability

to regulate the communications at such

activities is essential to the regulation of

drugs and devices. In view of the fact

that the regulation of drugs and devices

is an area of extensive federal

regulation, the agency may regulate the

communications at industry-supported
64078 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

3Senate Labor and Human Resources Committee,

Congressional Research Service, Survey of selected

pharmaceutical firms, Washington, DC, Government

Printing Office, 1991.

scientific and educational activities

without violating the First Amendment.

2. Commercial Speech

Assuming, contrary to the analysis

just presented, that industry-supported

scientific and educational activities

constitute protected speech, they are

commercial speech and FDA’s

regulation of such activities does not

violate the First Amendment. Although

the Supreme Court has furnished little

explicit guidance as to how to

determine whether speech is

commercial, it has provided some

suggestion as to what factors are

relevant when making a commercial

speech determination. (See Bolger v.

Youngs Drug Products), 103 S.Ct. 2875

(1983) (concluding that informational

pamphlets are commercial speech based

on a combination of three characteristics

(conceded to be advertisements,

reference to a specific product, and

economic motivation), but not

suggesting that each of these

characteristics is a necessary element of

commercial speech); S.U.N.Y. v. Fox,

109 S.Ct. 3028 (1989) (speech which

proposes a commercial transaction);

Cincinnati v. Discovery Network, 113

S.Ct. 1505 (1993) (speech which

proposes a commercial transaction).)

Furthermore, the Court has made clear

that speech which does more than

propose a commercial transaction

(linking a product to a current public

debate or containing discussions of

important public issues) is not

necessarily transformed into

noncommercial speech (Central Hudson

Gas & Electric Corp. v. Public Serv.

Comm’n, 100 S.Ct. 2343 (1980); Bolger,

103 S.Ct. at 2880–2881).

Applying the characteristics suggested

in Bolger (advertisement, reference to a

specific product, economic motivation)

or the test used in Fox and Discovery

Network (speech which proposes a

commercial transaction), industrysupported scientific and educational

activities are commercial speech. The

guidance at issue only applies to

activities that make reference to a

specific product, and as explained

below, the activities are economically

motivated and propose a commercial

transaction. Drug and device companies

sponsor such programs not only to

encourage scientific exchange,

education, and corporate goodwill, but

more importantly, to convince the

audience to prescribe, purchase, or

otherwise use the products mentioned.

A company-sponsored program that

discusses use of a company product

carries with it, at the least, an implicit

solicitation, and in many cases an

explicit one (cf. Central Hudson, 100

S.Ct. at 2352 (suggesting that most

businesses are unlikely to underwrite

promotions that are of no interest to

consumers); National Commission on

Egg Nutrition v. FTC, 570 F.2d 157 (7th

Cir. 1977) (advertisement by egg

industry trade association claiming no

relationship between eggs, cholesterol,

and heart disease constitutes

commercial speech)).

Indeed, a review of the medical

literature on industry-supported

scientific and educational activities

demonstrates that such activities are

economically motivated and propose a

commercial transaction. It is significant

to note that the number and cost of drug

company-supported symposia have

increased significantly over the years. In

1974, 16 drug companies sponsored

7,519 symposia, at a cost of 6.5 million

dollars. Roughly comparable figures

showed that in 1988 the same

companies sponsored 34,688 symposia

at a cost exceeding 85.9 million dollars.3

It is reasonable to conclude that drug

companies would not spend such large

sums of money if they did not view

these programs as an effective means to

promote their products. Numerous

reports in the medical literature support

this conclusion.

In an article entitled ‘‘Physicians and

the Pharmaceutical Industry: An

Alliance with Unhealthy Aspects,’’ 36

Perspectives in Biology and Medicine

376–394, 385 (Spring 1993), author

Robert C. Noble describes industrysponsored symposia as, ‘‘an effective

method for marketing new drugs,’’ and

explains that, ‘‘[t]he symposium, like the

promotional dinner, is frequently given

a neutral title that disguises any

promotional purpose * * *’’ (emphasis

added). (See also Lisa Bero, Alison

Galbraith, and Drummond Rennie, ‘‘The

Publication of Sponsored Symposiums

in Medical Journals,’’ New England

Journal of Medicine, 327:1135–1140,

1992 (demonstrating that published

symposia were promotional and not

peer-reviewed, and those that were

sponsored by a single company focused

on single products, had misleading

titles, and featured unapproved drugs).)

It has also been suggested that drug

companies will not provide financial

support for scientific and educational

activities unless those activities in some

way promote the supporting company’s

products. An editorial by Stephen E.

Goldfinger, in the New England Journal

of Medicine, addressed the growing

support and influence of the drug

industry in the education of physicians.

According to Dr. Goldfinger:

The most acceptable kind of educational

backing is the least available: donations to

providers of continuing medical education

that are unrestricted with respect to program

topics, speakers, or the backgrounds of the

invited registrants. When I have suggested

this model to pharmaceutical directors who

proclaim a genuine interest in supporting

continuing medical education, the usual

response is a quizzical smile followed by a

gentle reminder of the value of confining our

discussion to the realm of the possible. At a

minimum, that realm usually requires the

topic to be an area ‘‘of interest’’ to the

sponsor, meaning an area related to a product

line in need of promotion.

Stephen E. Goldfinger, ‘‘A Matter of

Influence’’ (Editorial), New England

Journal of Medicine, pp. 1408–1409,

1409 (May 28, 1987).

Similarly, 2 years later, Eugene M.

Bricker, wrote in the same journal that:

Most of the medical-service industry’s

marketing exercises are intended to be both

educational and promotional, and some are

indeed broadly educational and of excellent

quality. This does not alter the fact that

promotion is their basic objective; companies

would not subsidize marketing methods

unless they were rewarding.

Eugene M. Bricker, ‘‘Industrial

Marketing and Medical Ethics’’

(Editorial), New England Journal of

Medicine, pp. 1690–1692, 1691 (June 22,

1989). (See also Kenneth Miller,

William A. Gouveia, Michael Barza, et

al., ‘‘Undesirable Marketing Practices in

the Pharmaceutical Industry’’ (Letter to

the Editor), New England Journal of

Medicine, p. 54 (July 4, 1985) (Physician

and pharmacist members of a hospital

pharmacy committee expressing

concern that drug company grants to

support educational functions, such as

talks by visiting speakers, are sometimes

clearly linked to a request for the

admission of a drug to the hospital’s

formulary or increased use of the

product).)

Moreover, the results of a study by

Marjorie A. Bowman and David L.

Pearle, ‘‘Changes in Drug Prescribing

Patterns Related to Commercial

Company Funding of Continuing

Medical Education,’’ Journal of

Continuing Education in the Health

Professions, 8:13–20, 1988, confirm that

industry-supported scientific and

educational activities propose a

commercial transaction. Doctors

Bowman and Pearle analyzed the drug

prescribing patterns of physicians

attending three different continuing

medical education (CME) courses, each

of which was subsidized heavily by a

single, but different drug company. The

course topics were directly related to a

set of similar drugs from the same class.

Immediately prior to and 6 months after
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64079

4Marjorie A. Bowman, ‘‘The Impact of Drug

Company Funding on the Content of Continuing

Medical Education,’’Mobius, 6:66–69, January 1986.

5Lisa Bero, Alison Galbraith, and Drummond

Rennie, ‘‘The Publication of Sponsored

Symposiums in Medical Journals,’’New England

Journal of Medicine, 327:1135–1140, 1992.

each course, the physician attendees

were asked to identify the frequency of

prescriptions written for the set of

drugs. Despite the presumed

independence of CME course content, in

all three courses the rate of prescribing

for the drug of the sponsoring company

increased the greatest in absolute terms,

while prescribing rates for the other

drugs discussed in the program either

decreased or did not increase as much.

Thus, company funding of such

programs does appear to influence

physicians’ drug prescribing behavior in

favor of the sponsoring company’s

product. (See also Jerry Avorn, Milton

Chen, and Robert Hartley, ‘‘Scientific

and Commercial Sources of Influence on

the Prescribing Behavior of Physicians,’’

American Journal of Medicine, 73:4–8,

1982 (demonstrating that commercial

sources have greater influence over

prescribing behavior than scientific

sources of information); Robert S. Stern,

‘‘Drug Promotion for an Unlabeled

Indication—The Case of Topical

Tretinoin,’’ New England Journal of

Medicine,’’ 331:1348–1349, 1994

(demonstrating that reports of companysponsored studies and promotional

efforts, including symposia, were

associated with a large increase in

prescribing for an unapproved

indication).)

Thus, if industry-supported scientific

and educational activities constitute

protected speech, that speech is

‘‘commercial speech’’ for purposes of

constitutional analysis.

3. The Central Hudson Analysis

Over the past few decades, the

Supreme Court has afforded commercial

speech limited constitutional protection

(Virginia State Board of Pharmacy v.

Virginia Citizens Consumer Council,

Inc., 96 S.Ct. 1817 (1976); Central

Hudson, 100 S.Ct. at 2343; 44

Liquormart, Inc. v. Rhode Island, 116

S.Ct. 1496 (1996)). In Central Hudson,

the Supreme Court established a fourprong test to determine whether

limitations on commercial speech are

constitutional. The test inquires: (1)

Whether the speech concerns lawful

activity and is not misleading; (2)

whether the asserted government

interest is substantial; (3) whether the

limitation directly advances the

governmental interest asserted; and (4)

whether the limitation is not more

extensive than is necessary to serve that

interest (Central Hudson, 100 S.Ct. at

2351). Subsequently, in S.U.N.Y. v. Fox,

109 S.Ct. 3028 (1989), the Court

clarified that the fourth prong of the

Central Hudson test is not a ‘‘least

restrictive means’’ requirement; rather it

requires that the restriction be

‘‘narrowly tailored’’ to serve the asserted

government interest. Narrow tailoring

means ‘‘a fit that is not necessarily

perfect, but reasonable’’ between means

and ends (Id. at 3035).

FDA’s guidance on industrysupported scientific and educational

activities satisfies all four prongs of the

Central Hudson test.

a. The first prong. Commercial speech

that is false or misleading, or that

concerns illegal activity, is not protected

by the First Amendment and may be

banned (Zauderer v. Office of

Disciplinary Counsel, 105 S.Ct. 2265,

2275 (1985); Ibanez v. Board of

Accountancy, 114 S.Ct. 2084, 2088

(1994)). Commercial speech is

misleading when it is either inherently

likely to deceive or when experience

has shown that the speech has in fact

been deceptive (In Re R.M.J., 102 S.Ct.

929, 937 (1982)). Regulation of

commercial speech that is not

misleading, or that is only potentially

misleading, must satisfy the remaining

prongs of the Central Hudson test.

As previously discussed, industrysupported scientific and educational

activities that promote an unapproved

product, or promote an approved

product for an unapproved use, create

an unlawful product—a misbranded or

adulterated drug or device. Accordingly,

industry-supported activities that

promote unlawful products ‘‘concern

illegal activity’’ and may be prohibited.

Although FDA believes that most

industry-supported scientific and

educational activities are not inherently

misleading, they are clearly potentially

misleading. The potential to mislead the

listener (a health care professional) at

such an activity is heightened because

the listener must not only determine

whether the information presented is

scientifically sound, but also whether,

or to what extent, the supporting

company has influenced the

presentation.

Evidence of bias in the content of

industry-supported CME programs was

demonstrated in a study conducted by

Marjorie A. Bowman. Dr. Bowman

analyzed the content of two CME

programs on calcium channel blocker

drugs (approved for treating high blood

pressure) that were funded by different

drug companies. In each case, the

program speakers mentioned positive

effects more often in connection with

the sponsoring company’s drug and

negative effects more often with

competitors’ drugs.4 A second study

that analyzed the publication of

industry-sponsored symposia in

medical journals concluded that the

symposia were promotional in nature

and not peer-reviewed, and those that

were sponsored by single

pharmaceutical companies focused on

single drug products, had misleading

titles, and featured unapproved drugs.5

Additionally, there are numerous

reports in the medical literature

describing deceptive practices in the

design and delivery of industrysupported symposia. See e.g., Robert C.

Noble, ‘‘Physicians and the

Pharmaceutical Industry: An Alliance

with Unhealthy Aspects,’’ 36

Perspectives in Biology and Medicine

376–394 (Spring 1993); ‘‘Pushing Drugs

to Doctors,’’ Consumer Reports, 57:87,

Feb. 1992 (reporting on drug industry

marketing practices that mislead

doctors).

The potential to present misleading

information at industry-supported

activities is a particular concern when

unapproved uses are addressed.

Usually, unapproved uses have not been

vigorously evaluated, or if they have

been studied, the results are

inconclusive. Thus, unapproved uses

tend to lack the same degree of certainty

and confidence as FDA approved uses.

In fact, the data that can identify risks

associated with the unapproved use

often do not exist, and therefore

complete information about the risks of

the new use cannot be provided. This

lack of data, of course, does not make

all discussions about unapproved uses

misleading. However, it is important

that the audience understand the

limitations on data supporting

unapproved uses. The disclosure of

such limitations, as recommended in

the Final Guidance, will help ensure

that the audience understands the

uncertainty associated with unapproved

uses and not be misled into thinking

that such uses are safe and effective.

b. The second prong. FDA’s guidance

on industry-supported scientific and

educational activities serves the

substantial Government interest of

protecting the health and safety of its

citizens by helping to ensure the

dissemination of truthful and

nonmisleading information about drugs

and medical devices. The Supreme

Court has repeatedly held that the

Government’s ‘‘interest in the health,

safety, and welfare of its citizens

constitutes a substantial interest’’

(Posadas de Puerto Rico Associates v.

Tourism Co., 106 S.Ct. 2968, 2977
64080 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

6The prescription drug advertising regulations,

issued under section 502(n) of the act, provide that

an advertisement does not satisfy the requirement

that it present a ‘‘true statement’’ of information in

brief summary if it is false or misleading with

respect to side effects, contraindications, or

effectiveness (see 21 CFR 202.1(e)(5)(i)). In addition,

the regulations list 33 ways in which prescription

drug advertisements may be false or misleading (see

21 CFR 202.1(e)(6) and (e)(7)).

(1986); Rubin v. Coors, 115 S.Ct. 1585,

1591 (1995)).

In order to protect and promote the

public health, Congress granted FDA

broad statutory authority to ensure that

promotional activities (labeling and

advertising) for drugs and devices are

truthful and not misleading. Section

502(a) of the act provides that a drug or

device is deemed to be misbranded if its

labeling is false or misleading in any

particular, and under section 502(q) of

the act a restricted medical device is

misbranded if its advertising is false or

misleading in any particular. A

prescription drug is misbranded under

section 502(n) of the act unless the

manufacturer, packer, or distributor

includes in all advertisements with

respect to that drug, ‘‘a true statement of

* * * information in brief summary

relating to side effects,

contraindications, and effectiveness

* * *.’’6 Similarly, a restricted device is

misbranded under section 502(r) of the

act unless the manufacturer, packer, or

distributor includes in all

advertisements with respect to that

device, ‘‘a true statement of * * * the

intended uses of the device and relevant

warnings, precautions, side effects, and

contraindications * * *.’’ Moreover,

section 201(n) of the act specifically

explains that if an article is alleged to

be misbranded because the labeling or

advertising is misleading, there shall be

taken into account not only

representations or suggestions made in

the labeling or advertising, but also the

extent to which the labeling or

advertising fails to reveal material facts.

The dissemination of false or misleading

information about drugs and devices

can induce physicians to choose

therapies that deprive patients of

reliable treatment and cause severe

morbidity, life-threatening adverse

effects, or death.

FDA’s guidance also serves to protect

the public health by preserving the

integrity of the premarket approval

process, a second substantial

government interest. As explained

earlier, by enacting the act, Congress

established a premarket approval and

clearance process whereby

manufacturers must establish that their

drugs and devices are safe and effective

for each of their intended uses before

they can be marketed and promoted for

those uses. Manufacturers of drugs and

devices are not permitted to promote

unapproved products or unapproved

uses of approved products, either

directly or indirectly, such as through

industry-supported scientific and

educational activities. This regulatory

requirement is an important incentive

for manufacturers to conduct studies to

determine whether their products are

safe and effective. If premarket approval

were not required for each intended use

and manufacturers were free to promote

products for any use, manufacturers

would have little reason to do scientific

research and to present their data to

FDA. Additionally, it is important to

note that the approval of a drug or

device for one use does not provide

assurance that the product is safe or

effective for a different use or use in a

different patient population.

Consequently, the promotion of

unapproved uses raises significant

safety concerns, which are more fully

discussed below.

c. The third prong. FDA’s guidance on

industry-supported scientific and

educational activities directly advances

the government’s substantial interests.

‘‘[A] governmental body seeking to

sustain a restriction on commercial

speech must demonstrate that the harms

it recites are real and that its restriction

will in fact alleviate them to a material

degree’’ (Edenfield v. Fane, 113 S.Ct.

1792, 1800 (1993)).

FDA’s guidance directly advances the

Government’s interest of protecting the

health and safety of its citizens by

helping to ensure the dissemination of

truthful and nonmisleading information

about drugs and devices. The guidance

includes a number of suggestions on the

design and conduct of industrysupported scientific and educational

activities so that they will be free from

the promotional influence of the

supporting company and not

misleading. Such suggestions include,

for example, meaningful disclosure of

the company’s funding of the program

and any significant relationship

between the provider (an entity, other

than a regulated company, that

produces the activity or program),

presenter, and supporting company;

giving the provider full control over the

content of the program and selection of

speakers; avoiding involvement of the

sales or marketing departments of the

supporting company in audience

selection decisions; and not having

promotional activities in the meeting

room. Industry-supported activities that

are designed and carried out in this

manner are less likely to result in the

dissemination of false, misleading, or

biased information that can adversely

affect public health.

On a number of occasions, FDA has

become aware of and taken action

against industry-supported scientific

and educational activities that were

false or misleading, and that could have

caused harm to patients. For example, a

few years ago, agency staff viewed two

videotaped presentations on treating

gallstone disease that were broadcast

nationwide on a cable television

network intended for physicians. The

videos were produced and paid for by

a major drug company and prominently

featured a drug marketed by the

company for the chemical dissolution of

certain gallstones. The programs

encouraged doctors to prescribe this

drug instead of surgery to treat gallstone

disease. These representations and

suggestions were false or misleading

because: (1) The drug is approved only

for dissolving certain types and sizes of

gallstones in patients for whom surgery

is not medically appropriate, or for

patients who refuse surgery, and (2)

surgery is more effective and is the

preferred treatment for almost all

patients with gallstone disease.

These industry-sponsored

presentations could have caused many

physicians to make inappropriate and

potentially harmful treatment decisions.

After FDA notified the sponsoring

company that the programs were false or

misleading, the company agreed to take

appropriate corrective action.

In a more recent example, a major

drug company sponsored a misleading

symposium on cyclosporine drug

products (approved to prevent organ

rejection in kidney, liver, and heart

transplant patients), held in conjunction

with the annual meeting of the

American Society of Transplant

Physicians. The sponsoring company’s

‘‘pioneer’’ (nongeneric) cyclosporine

drug product was about to lose patent

protection and face competition from

lower-priced generic cyclosporine

products at the time of the symposium.

An investigation by FDA revealed that

the sponsoring company and its agent

specifically requested that one invited

speaker revise his abstract to remove

any references to the impending

availability of generic cyclosporine

products, to delete or revise sections of

text that did not support switching

stable patients to the sponsoring

company’s product, and to make other

revisions to his presentation. Despite

the speaker’s insistence on including his

abstract as originally written, the

sponsoring company again asked the

speaker to revise his abstract and

presentation. When the speaker again

refused to revise his abstract, it was not
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64081

7 More Information for Better Patient Care:

Hearing on S. 1477 Before the Senate Comm. on

Labor and Human Resources, 104th Cong. 51, 78–

79 (1996) (statement of Thomas J. Moore, Senior

Fellow, Center for Health Policy Research, George

Washington University).

included in the program materials

disseminated during the symposium.

The sponsoring company’s actions to

control the content of the symposium

resulted in a misleading presentation in

that: (1) The sponsoring company

implied that the speakers were speaking

without editorial input or influence

from the sponsoring company, and (2)

the sponsoring company foreclosed a

full discussion of all cyclosporine drug

products. The sponsoring company’s

efforts undermined the unbiased

exchange of scientific information, may

have caused physicians to unnecessarily

switch stable patients to the company’s

product, and likely resulted in greater

than necessary expenditures by patients.

This might not have been the case had

the sponsoring company, consistent

with the agency’s longstanding policy as

articulated in the Draft Policy

Statement, not influenced the content of

the program.

FDA’s guidance also directly

advances the Government’s interest of

protecting the public health by

preserving the integrity of the premarket

approval process. The act requires

sponsors to establish that their drugs

and devices are safe and effective for

their intended uses before they can be

marketed and promoted. Consistent

with this statutory scheme, FDA has

consistently prohibited the promotion of

unapproved products and unapproved

uses of approved products. As

explained earlier, this preserves the

incentive for sponsors to conduct the

adequate and well-controlled clinical

investigations that are necessary to

demonstrate whether products are safe

and effective for each of their intended

uses, and prevents patients from being

exposed to unnecessary harms. There

are, unfortunately, several examples of

harms associated with the promotion of

unapproved uses.

For example, several manufacturers of

calcium channel blockers (drugs

approved to treat a type of chest pain

known as angina) attempted to promote

these products for use in patients who

had recently suffered heart attacks,

called acute myocardial infarctions

(post-AMI patients). The use of calcium

channel blockers in post-AMI patients is

not an approved use, and the agency

successfully thwarted these promotional

efforts. Many studies of post-AMI

calcium channel blocker use have failed

to show benefits, and some studies

suggest that they may cause harm,

particularly in patients with poor heart

function. Given the many patients who

suffer an AMI each year, the loss of life

could have been in the thousands if the

manufacturers had promoted this use.

In another example, certain approved

anti-arrhythmic drugs were illegally

promoted for unapproved uses in postAMI patients. Included in these

promotional activities were industrysponsored lectures, presentations, and

other publicity events. Use of antiarrhythmic drugs for this unapproved

use was substantial and growing until a

clinical study (the CAST study) was

conducted to evaluate definitively the

safety and effectiveness of this use. The

study produced a highly unexpected

result in that the treatment with antiarrhythmic drugs produced a 2.5-fold

increase in mortality. It is estimated that

tens of thousands of deaths were

associated with this unapproved use.7

More detailed information on the

preceding examples and additional

examples involving drugs, biologics,

and devices are contained in an FDA

Federal Register notice requesting

comments on a citizen petition

submitted by the Washington Legal

Foundation (see 59 FR 59820, November

18, 1994).

FDA’s guidance on industrysupported scientific and educational

activities protects the integrity of the

premarket approval process because it

dissuades manufacturers from using

such activities as a means to promote

unapproved products and unapproved

uses; thereby encouraging scientific

research and eliminating unnecessary

harms to patients. At the same time,

however, the agency acknowledges that

drug and device manufacturers have an

important role in legitimate scientific

and educational discussions, including

discussions of unapproved products and

unapproved uses. Accordingly, the

guidance recognizes that discussions of

unapproved uses at industry-sponsored

activities may be appropriate, and

suggests that the provider include a

general disclosure to the audience as to

whether any unapproved uses will be

discussed. This disclosure

accommodates the need for industrysupported discussion on unapproved

uses, yet helps ensure that the

information presented is not misleading

so as to be misconstrued as discussion

of an approved use.

d. The fourth prong. The agency

believes that the guidance is ‘‘narrowly

tailored’’ and a reasonable approach to

protect the health and safety of

consumers by discouraging the

dissemination of misleading or biased

information, and by maintaining the

integrity of the premarket approval

process. The ‘‘Factors Considered in

Evaluating Activities and Determining

Independence,’’ in section II.A. of the

Final Guidance, are ‘‘reasonable means’’

of distinguishing industry-supported

activities that are intended to be

promotional from those that are

intended to be nonpromotional and free

from the supporting company’s

influence and bias.

The Supreme Court has expressed a

willingness to defer the fourth-prong

determination to the regulating body.

(See Fox, 109 S.Ct. at 3035; United

States v. Edge Broadcasting Co., 113

S.Ct. 2696, 2707 (1993).) Since Fox, the

Court has applied the ‘‘reasonable fit’’

standard to uphold the regulation of

commercial speech. (See Edge, 113 S.Ct.

at 2705; Florida Bar v. Went For It, Inc.,

115 S.Ct. 2371, 2380 (1995).) Moreover,

the courts have granted greater leeway

and upheld reasonable regulation of

commercial speech with regard to

potentially harmful activities. (See Edge,

113 S.Ct. 2696 (upholding Federal

prohibition of lottery advertising on

radio in nonlottery State); AnheuserBusch, Inc. v. Schmoke, 63 F.3d 1305

(4th Cir. 1995), cert. denied, 65 U.S.L.W.

3723 (April 28, 1997) (No. 96–1428)

(upholding restrictions on outdoor

advertising of alcoholic beverages);

Penn Advertising of Baltimore, Inc. v.

Mayor and City Council of Baltimore, 63

F.3d 1318 (4th Cir. 1995), cert. denied,

65 U.S.L.W. 3723 (April 28, 1997) (No.

96–1428) (upholding restrictions on

outdoor advertising of cigarettes).)

Certainly, with regard to the regulation

of potentially dangerous drugs and

medical devices, FDA is entitled to the

same, if not greater, deference.

FDA’s guidance on industrysupported scientific and educational

activities is narrowly tailored. The

guidance applies only to those industrysupported activities that relate to the

supporting-company’s product(s) or to

competing product(s). It is directed to

the regulated sponsors of such activities

(drug and device manufacturers) rather

than the participating professionals. It

does not apply at all to independent

scientists and organizations (e.g.,

universities, medical societies,

professional groups), which may freely

participate in or sponsor scientific or

educational activities. Additionally, the

agency has made clear that it does not

seek to regulate all industry-supported

scientific and educational activities

under the labeling and advertising

provisions of the Act. As explained in

the guidance, FDA has not regulated

and does not intend to regulate

industry-supported activities that are
64082 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

independent of the promotional

influence of the supporting company.

The Final Guidance suggests that the

provider ensure:

[M]eaningful disclosure, at the time of the

program, to the audience of: (1) the

company’s funding of the program; (2) any

significant relationship between the provider,

presenters or moderators, and the supporting

company (e.g., employee, grant recipient,

owner of significant interest or stock); and (3)

whether any unapproved uses of products

will be discussed.

These disclosures are fully consistent

with the First Amendment. (See

Virginia Board of Pharmacy, 96 S.Ct. at

1830 n. 24 (‘‘They may also make it

appropriate to require that a commercial

message appear in such a form, or

include such additional information,

warnings, and disclaimers, as are

necessary to prevent its being

deceptive.’’); In Re R.M.J., 102 S.Ct. at

926 (‘‘a warning or disclaimer might be

appropriately required * * * in order to

dissipate the possibility of consumer

confusion or deception.’’); Zauderer,

105 S.Ct at 2282 and n.14 (holding that

disclosure requirements do not violate

the First Amendment as long as they are

reasonably related to the state’s interest

in preventing deception, and indicating

that disclosure requirements are one of

the acceptable less restrictive

alternatives to actual suppression of

speech).)

The agency’s suggested disclosures

are reasonably related to ensuring that

the audience is in a position to fully

evaluate the information presented, in

order to avoid being misled, confused,

or deceived. The guidance suggests that

the disclosures be ‘‘meaningful’’ and ‘‘to

the audience.’’ It does not specify how

or when during the activity the

disclosures should be delivered, or what

should be said. Furthermore, as

explained previously, the guidance

suggests that the provider disclose

whether any unapproved uses of

products will be discussed. It recognizes

that discussions of unapproved uses

may be appropriate.

Finally, in response to comments, the

agency made revisions to the Draft

Policy Statement (reflected in the Final

Guidance) that are additional evidence

of ‘‘narrow-tailoring.’’ The most

significant change was to place less

emphasis on the elements of a written

agreement between the supporting

company and the provider, and instead

provide guidance on what the agency

will consider in evaluating activities

and determining independence (Factors

Considered in Evaluating Activities and

Determining Independence). The Final

Guidance makes clear that the list of

factors is not exhaustive and that other

factors may be appropriate for

consideration in a particular case. The

supporting company and the provider

are free to adopt alternative approaches

to help ensure that activities are

independent and nonpromotional.

4. Conclusion

FDA strongly believes that the Draft

Policy Statement and the Final

Guidance on Industry-Supported

Scientific and Educational Activities do

not abridge the First Amendment

because the agency’s ability to regulate

such activities is essential to the

regulation of drugs and devices, and the

regulation of drugs and devices is an

area of extensive Federal regulation. If

however, such activities are considered

protected speech, they are commercial

speech. The guidance satisfies all

prongs of the Central-Hudson test, and

thus, does not violate the First

Amendment.

C. Scope

4. Several comments from the medical

device industry argued that medical

devices should be exempt from the

policy. Some comments recommended,

in the alternative, that there be a

separate policy specific to medical

devices. They argued that the policy

initiative resulted from an effort to

address abuses in the pharmaceutical

industry, and that such abuses are not

characteristic of the educational

programs supported by medical device

companies. Moreover, they maintained

that educational programs for devices

are more in the nature of hands-on

training programs and thus present

unique issues that would make

compliance with a number of provisions

of the draft policy statement (e.g.,

multiple presentations, audience

selection) impractical or impossible.

The agency declines to exempt

medical devices from the final guidance.

The statutory concepts of labeling,

advertising, and intended use do not

differ for drugs and medical devices.

‘‘Hands-on’’ training sessions sponsored

by device manufacturers are inherently

product-specific and generally do not

fall within the description of

independent and nonpromotional

educational programs that are

contemplated by the final guidance.

Training provided or supported by

device manufacturers related to labeled

uses would present no difficulty for the

sponsor. Industry-supported training for

off-label uses, however, will ordinarily

be viewed by the agency as violative of

the act.

5. Several comments from the animal

drug industry and the veterinary

community contended that animal

drugs should be exempt from the policy.

They argued that the animal drug

industry is not prone to the same abuses

as the human drug industry, that the

process by which continuing education

programs are provided to veterinarians

is not comparable to the process by

which continuing education is provided

to other health care professionals, and

that the administrative burdens and

resulting expense imposed by the policy

would restrict the availability of

educational programs for veterinarians.

The agency acknowledges that the

processes by which continuing

education is provided for veterinary

health care professionals differs in many

ways from continuing education for

other health care professionals.

Nevertheless, the basic principles

embodied in the final guidance, the

importance of independence,

disclosure, and educational design and

intent apply to veterinary continuing

medical education just as they apply to

other industry-sponsored professional

education.

6. Several comments addressed the

scope of activities that are affected by

the policy. Some comments contended

that the scope of the policy has been

appropriately narrowed to scientific and

educational activities directed to health

care professionals. They supported the

exclusion of activities directed at

business, policy, or other nonhealth care

professional groups. Other comments

argued that the scope should be

narrowed further to encompass only

those industry-supported educational

activities directed to health care

professionals who are involved in

prescribing or administering regulated

products. Several comments expressed

concern that the scope of activities to

which the policy applies, beyond live

presentations, is unclear. They

expressed concern about the extent to

which the policy applies to

presentations in electronic and other

media. They contended that the policy

should set forth the limitations of its

application and, moreover, should

expressly exempt written materials from

the scope of its application.

Although this final guidance is

intended to address industry-supported

scientific and educational activities

directed to health care professionals, the

agency anticipates that presentations to

other audiences may lend themselves to

the principles described in this final

guidance. It is understood that a large

majority of health care professionals

participate in the diagnostic and

therapeutic management of patients and

are, therefore, in a position to either

prescribe, influence prescribing, or

monitor the effectiveness of regulated

medical products. Information
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64083

presented at continuing education

programs may have a significant impact

on these health care professionals.

There is no basis for applying a

substantially different policy to

industry-supported educational or

scientific activities that are broadcast,

electronically recorded, or disseminated

via other emerging media.

7. One comment requested that the

agency clarify that the policy applies

generally to continuing medical

education and also to industrysupported educational activities

directed to health care professionals.

The comment was concerned that the

reference to continuing medical

education, in the first sentence of the

first paragraph of the background

section of the draft policy statement,

suggests that the scope of the policy

may be limited to continuing medical

education.

The agency agrees with the comment

and has revised the language to refer to

‘‘continuing education for health care

professionals.’’

8. One comment was concerned that

the language in the background section

of the draft policy statement implies

that only independent activities, as

described in the draft policy statement,

can be considered educational activities.

The comment stated that accredited

educational activities that are not free

from company influence, yet not

inconsistent with approved labeling for

any company product discussed, will no

longer be regarded as legitimate

educational activities.

The final guidance is not intended to

distinguish between education and

promotion and does not suggest that

company influenced activities are

illegitimate or noneducational. To

clarify this intent, FDA has added a

sentence to the background section,

which states that the agency recognizes

that industry-supported activities can be

both nonpromotional and educational.

The final guidance is intended to

distinguish between industry-supported

activities that the agency does not

intend to regulate because they are

otherwise independent of company

influence and those that are subject to

regulation because of the substantive

influence of the supporting company.

Company-influenced activities that

provide information to health care

professionals on regulated products may

be educational in nature. They are,

nevertheless, subject to regulation and,

thus, must be consistent with approved

labeling.

9. Some comments were concerned

that the policy narrows or eliminates the

ability of companies to engage in

scientific exchange as provided for in

§ 312.7(a) (21 CFR 312.7(a)) (human

drugs) and § 511.1(b)(8)(iv) (21 CFR

511.1(b)(8)(iv)) (animal drugs). The

comments contended that the draft

policy statement seems to subject

company-controlled scientific exchange

to regulation because it is not an

independent activity. They contended

that appropriate company-controlled

scientific exchange should be expressly

exempted from regulation in the policy.

This final guidance seeks to clarify

the distinction between the concepts of

promotion/commercialization and

industry-supported scientific exchange

set forth in §§ 312.7(a) (human drugs)

and 511.1(b)(8)(iv) (animal drugs).

Programs supported by companies that

are not otherwise independent scientific

or educational activities are subject to

regulation as product promotion/

commercialization.

10. Several comments contended that

the policy is fundamentally flawed in

that it institutionalizes industry support

for continuing education activities for

health care professionals. One comment

argued that part of the definition of

continuing medical education should be

that it is nonsubsidized. Other

comments recommended that the

agency encourage multiple-source

funding for educational activities to

minimize the potential for bias as the

policy may not be adequate to prevent

the subtle bias inherent in a single

sponsor situation.

The ‘‘institutionalization’’ of industry

support for continuing education

predates the agency’s draft policy

statement. The agency has sought to

avoid, through its policy, undue

interference with the availability of

continuing education. Although FDA

shares the concerns of some health care

professionals that substantial reliance

on industry funding may result in bias

in continuing education, such should be

addressed by the profession rather than

by the agency. Although enlisting

multiple sponsors would likely reduce

the potential for bias toward any one

product, the agency believes that this

approach may not be practical, in all

instances, for all FDA-regulated

products.

D. Background: Promotion, Education,

and Independence

11. Some comments objected to

language in the background section of

the draft policy statement indicating

that, in assessing whether an industrysupported activity is independent, the

agency will examine whether and to

what extent the company ‘‘is in a

position to influence’’ the presentation.

They contended that the correct inquiry

is whether a company has actually

influenced a presentation, not whether

a company was in a position to

influence the presentation.

The agency cannot, in all cases,

presume a provider to be independent

merely because there is no documented

attempt by the supporting company to

influence the program. Business

relationships or other relationships may

influence a provider. A provider whose

continued existence depends on the

funding and goodwill of a supporting

company may, for practical purposes, be

in the same position as a company

employee, who depends on his or her

salary. Whether or not a company is in

a position to influence the presentation

is important in determining whether the

activity is independent.

12. One comment objected to the first

sentence of the fifth paragraph to the

background section of the draft policy

statement; this sentence indicated that,

in assessing whether an activity is

independent, the agency will examine

whether and to what extent the

company is in a position to ‘‘otherwise

use the presentation as an advertising

vehicle.’’ The comment contended that

this language is ambiguous as to what

might cause the agency to conclude that

a supporting company has otherwise

used a presentation as an advertising

vehicle.

The agency agrees that clarification

may be helpful. Accordingly, FDA has

revised the text to state that the agency

will examine whether and to what

extent the company is in a position to

‘‘otherwise transform an ostensibly

independent program into a

promotional vehicle.’’

13. One comment suggested that the

example provided in the parenthetical

statement in the fifth paragraph to the

background section of the draft policy

statement (57 FR 56412 at 56413) be

changed from ‘‘if the provider believes

that future financial support from the

company depends upon producing

programs that promote the company’s

product’’ to ‘‘if the provider has reason

to believe * * *.’’

The agency agrees with the suggested

change and has revised that section of

the final guidance accordingly.

E. Policy: Scientific and Educational

Activities Supported by Industry

The draft policy statement, in

discussing FDA policy generally, stated

that the agency ‘‘has not regulated and

does not intend to regulate under the

labeling and advertising provisions of

the act industry-supported scientific

and educational activities that are

independent of the influence of the

supporting company’’ (57 FR 56412 at

56413). The agency further stated that
64084 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

‘‘companies and providers who wish to

ensure that their activities will not be

subject to regulation should design and

carry out their activities based on a

written agreement * * * that the

provider will be solely responsible for

designing and conducting the activity

* * *.’’

14. Some comments contended that to

make the provider solely responsible for

design and conduct of an educational

activity excessively restricts supporting

company involvement. They suggested

revising the text to make the provider

‘‘ultimately’’ responsible for design and

conduct of an educational activity.

In order to maintain the concept of

independence described in this final

guidance, it is important to retain the

concept of provider ‘‘sole

responsibility’’ for the design and

conduct of the activity. This guidance is

not designed to restrict companies from

continuing to provide programs for

health care professionals, but to

distinguish between activities that are

otherwise independent from the

promotional influence of the supporting

company and those that are not. A

provider who merely adopts a companydesigned presentation has not

functioned as a truly independent

educational provider.

1. Written Agreement—Generally

Although the draft policy statement

did not require a written agreement, it

did state that a written agreement can

‘‘play an important role in helping to

ensure that an industry-sponsored

activity comes within the safe harbor

traditionally recognized by the agency

for independent scientific and

educational activities’’ (57 FR 56412 at

56413). The draft policy statement also

described 10 elements the agency would

anticipate in such written agreement.

As discussed in comment 15 of

section II.E.1. of this document, the final

guidance was modified to place less

emphasis on a written agreement, but

states that a written agreement is one

way to document what measures were

taken by the parties to maintain the

independence of an activity.

15. Several comments suggested that

a written agreement between the

provider and supporting company was

required and overly burdensome, both

substantively and administratively.

These comments identified a number of

possible consequences including,

foremost, that the written agreement

would function as a disincentive for

industry to support continuing

education, resulting in fewer and lower

quality educational activities. Several

comments objected to the written

agreement in general as overly

restrictive and intrusive, containing too

many elements, unwieldy, and/or

impractical. The comments suggested,

among other things, that there should be

no requirement at all, that the agreement

should provide only that the provider

exercises final control and that the

agreement should provide only that the

program be objective, balanced, and

scientifically rigorous, and that there be

disclosure with all other details left to

the parties. Other comments

recommended that the agency develop a

‘‘generic’’ written agreement, or

alternatively, provide guidance to

national accrediting organizations as to

the content of acceptable standardized

written agreements. Still other

comments were supportive of the

concept of a written agreement, did not

anticipate that written agreements

would be unduly burdensome, and

moreover, maintained that the written

agreement would improve the process of

developing meaningful educational

activities. Some comments suggested

that, for their purposes, the fact that

clear guidance, which distinguishes

regulated from nonregulated activities

exists, may be more important than

what the guidance actually contains.

The comments complained that the lack

of guidance, and resulting uncertainty

as to the regulatory consequences of

industry support for scientific and

educational activities, have made

industry reluctant to provide support for

these activities.

As noted earlier, the agency has

clarified its intention that a written

agreement between the supporting

company and the provider is

recommended, and not required. The

final guidance recognizes that a written

agreement is one way of documenting

the measures taken by the provider and

the supporting company to ensure

independence of an activity. The agency

does not anticipate that a written

agreement would be an undue burden

for any of the parties involved in

continuing education for health care

professionals. Moreover, the agency

anticipates that such agreements will

enhance, rather than detract from, the

quality of industry-supported

educational activities.

16. One comment contended that

failure to abide by the terms of a written

agreement should subject the parties to

additional penalties beyond those

currently provided for in the act.

The agency believes that its existing

statutory authority is sufficient to

address industry-supported activities

that are subject to regulation and may be

violative.

2. Statement of Purpose

The draft policy statement’s

‘‘Statement of Purpose’’ section (section

II.A.1.) advised that the company and

the provider should agree that the

program ‘‘is for scientific or educational

purposes and not for the purpose of

promoting any product and that any

discussion of the company’s products

will be objective, balanced and

scientifically rigorous’’ (57 FR 56412 at

56413).

FDA has deleted the ‘‘Statement of

Purpose’’ section because the elements

of a written agreement are no longer

described in the final guidance.

3. Control of Content/Selection of

Presenters

The draft policy statement stated that

the provider would be responsible for

exercising full control over the planning

of the program’s content, including the

selection of presenters and moderators.

The draft policy statement indicated

that companies should ‘‘play no role in

the selection of presenters or moderators

other than responding to provider

requests’’ for such persons, but that

companies could make unsolicited

suggestions of speakers to ‘‘nationally

recognized accrediting organizations

that compile lists of speakers * * *’’ (57

FR 56412 at 56413). The draft policy

statement specified further details

regarding requests for speakers, such as

having companies agree to provide,

where reasonably possible, the names of

more than one suggested presenter and

to ‘‘disclose all known significant

financial and other relationships

between the company and suggested

presenter.’’ The draft policy statement

stated that providers should agree to

seek suggestions for presenters from

sources other than the company, to

make independent judgments on

appropriate presenters, and to select

presenters ‘‘representing an appropriate

diversity of legitimate medical opinion

on the topic under discussion when the

format permits * * *’’ (57 FR 56412 at

56413). Additionally, the draft policy

statement stated that providers should

agree to disclose whether a presenter

was suggested by the company. The

final guidance includes a factor

concerning ‘‘Control of Content and

Selection of Presenters and Moderators’’

(section II.A.), which contains most of

the concepts described in the draft

policy statement.

17. Several comments objected to the

provision in the draft policy statement

concerning presenters suggested by the

supporting company. The comments

objected in particular to the statement

that the provider agrees to disclose
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64085

when it has selected a presenter

suggested by the supporting company.

These comments contended that such

disclosure is unnecessary because it

unfairly raises the specter of bias as to

that presenter and, moreover, the

‘‘Disclosure of Financial Relationships’’

element of the draft policy statement

(section II.A.3.) provides for adequate

disclosure of any significant

relationship between the presenter and

the supporting company. Other

comments contended that the

supporting company should under no

circumstances be permitted to suggest

presenters.

As stated in the draft policy

statement, there is a perceived need on

the part of some providers for assistance

from supporting companies in

identifying appropriate speakers. The

agency is unwilling, at this time, to infer

undue influence by the supporting

company if it responds to a request from

such a provider. Health care

professionals are entitled to know the

nature of any involvement by

supporting companies in educational

efforts. However, the agency agrees with

the comment that disclosure of any

significant relationship between the

provider, supporting company, and

presenters or moderators would be

sufficient. The possibility of

unwarranted bias against presenters

suggested by industry should be dealt

with in the open environment of

scientific exchange. Accordingly, the

final guidance does not address specific

disclosure of the supporting company’s

suggestions for speakers or moderators.

18. Some comments objected to the

statement that a supporting company,

when responding to a provider request

for suggestions of presenters, agree to

disclose all known significant financial

and other relationships between the

suggested presenter and the supporting

company. They argued that this

provision is burdensome and redundant

in light of the disclosure obligation in

the ‘‘Disclosure of Financial

Relationships’’ section of the draft

policy statement (section II.A.3.).

The agency believes that a presenter’s

significant relationships with a

supporting company are, like a

presenter’s qualifications, essential to a

provider’s informed decision as to the

appropriateness of a suggested

presenter. Although the final guidance

does not specifically state that the

agency will consider whether the

supporting company disclosed such

relationships, it is suggested that this

type of disclosure be made.

The agency does not agree that this

disclosure is redundant with the

‘‘Disclosures’’ section of the final

guidance (section II.A.) because the two

provisions serve different purposes. The

disclosure made by the supporting

company when suggesting a speaker is

to assist the provider in evaluating the

appropriateness of the suggestion. The

‘‘Disclosures’’ section of the final

guidance is to inform the audience, at

the time of the program, of the

presenter’s relationship with the

supporting company in order to provide

the audience a perspective from which

to evaluate the information conveyed by

the presenter. The agency does not view

the supporting company’s disclosure

when suggesting a presenter as more

comprehensive than the disclosure to

the audience in the ‘‘Disclosures’’

section.

4. Disclosure of Financial Relationships

The draft policy statement suggested

that, as part of the written agreement,

the provider agrees to ‘‘ensure

meaningful disclosure’’ of the

company’s funding of the activity and

‘‘any significant relationship between

the provider and the company and

between individual presenters or

moderators and the company * * *’’

(57 FR 56412 at 56413). In the final

guidance, this provision is incorporated

in the general ‘‘Disclosures’’ section.

19. Several comments sought

clarification as to what is meant by

‘‘meaningful’’ disclosure and

‘‘significant’’ relationships. Several

comments also contended that this

provision is an administrative burden,

and that it places a disproportionate

burden on the provider, as opposed to

the supporting company and presenters.

Significant relationships are

relationships that may give rise to actual

or perceived conflicts of interest. The

concept of disclosure of relationships

that may give rise to conflicts of interest

has specific and well-understood

application to medical and scientific

discourse (e.g., in publication and in the

peer-review process). The agency

envisions that this provision can be

satisfied by disclosing the existence of

and characterizing significant

relationships, and need not include

further detail such as the amount of

compensation or funding received.

Thus, this disclosure should impose

only a minimal burden on providers,

presenters, and supporting companies.

Where there is a question as to whether

a relationship is significant, providers,

presenters, and supporting companies

should disclose the existence of the

relationship.

Meaningful disclosure is disclosure

that is reasonably calculated to reach

the relevant audience in a manner that

will alert them to potential biases. The

provider should determine how to

ensure that disclosure is meaningful.

20. One comment contended that

significant relationships between the

supporting company and providers and

presenters should preclude any

characterization of the activity as an

independent educational activity

inasmuch as disclosure is not adequate

to cure the taint of influence.

It is neither practical nor justified to

make a potential conflict of interest an

absolute bar to participation in an

independent educational activity.

Disclosure of such potential conflicts is

a workable means to address the

potential for bias in medical and

scientific contexts, and there is no

reason to believe that it will be any less

workable in addressing the potential for

bias in the context of industrysupported scientific and educational

activities.

21. Another comment argued that

disclosure is the only element of the

written agreement that should be

retained, that company involvement

should be permitted, and that it should

be left to the judgment of the audience

as to how to evaluate the content of the

program.

While disclosure may be deemed by

some in the health care profession a

proper solution to concerns about bias,

the agency’s concerns are not wholly

satisfied by disclosure. Under the act,

the regulated industry cannot promote

its products for unapproved uses, or

otherwise promote drugs, biologics, or

medical devices in ways not consistent

with approved labeling, even in the

context of unbiased presentations in

which the company’s role is fully

disclosed. Discussions of unapproved

uses, or other matters not consistent

with approved labeling, should occur in

a context of independent scientific or

educational activity produced by

organizations and individuals who are

not involved in marketing the products.

Thus, disclosure alone is not adequate

to ensure independence in industrysupported scientific and educational

activities as it does not insulate such

activities from the substantive influence

of supporting companies.

5. Supporting Company Involvement in

Content

The draft policy statement suggested,

as part of the written agreement, that a

company agree not to engage in

scripting, targeting of points for

emphasis, or other activities that are

designed to influence a program’s

content. The draft policy statement

indicated, however, that companies

could provide ‘‘limited technical

assistance * * * in preparing slides or
64086 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

audiovisual materials * * *’’ (57 FR

56412 at 56413). In the final guidance,

this discussion is included in the

‘‘Control of Content and Selection of

Presenters and Moderators’’ factor.

Although discussion regarding ‘‘limited

technical assistance’’ is not included in

the final guidance, as discussed in the

response to comment 22 of section

II.E.5. of this document, technical

assistance is a concern.

22. Several comments recommended

that the agency more clearly define the

limits of permissible technical

assistance. Some comments argued that

the policy should preclude all technical

assistance, as to permit such assistance

opens the door to influence. Other

comments raised concerns that the

policy is overly restrictive as to

technical assistance in which

supporting companies may engage.

Several comments argued that

supporting companies should be

allowed to script, target points for

emphasis, and provide unlimited

technical assistance so long as such

influence does not unfairly bias the

program.

The agency continues to believe that

the supporting company should not

engage in activities that could influence

the presentation’s content. Activities

such as scripting and targeting points

for emphasis can have a direct effect on

the presentation’s direction, balance,

and overall message. A companydesigned and financed presentation,

even if approved by an independent

provider, remains, in the agency’s view,

an activity that is not independent.

In addition, because the agency shares

the concern that technical assistance

may open the door to influence, the

agency suggests that the supporting

company should provide limited

technical support only in response to an

unsolicited request for assistance from

either the provider or a presenter.

6. Ancillary Promotional Activities

The draft policy statement indicated

that the written agreement should

include an agreement by supporting

companies to not have any promotional

activities or promotional exhibits ‘‘in

the same room or in an obligate path to

the educational activity, unless the

exhibit is within an area that is

designated for general exhibits and

includes exhibits from different

companies marketing alternative or

competing therapies.’’ Additionally,

providers would agree that no

advertisements for the supporting

company’s products would appear in

any materials disseminated in the

program room (57 FR 56412 at 56413).

The final guidance states that one factor

the agency will consider is whether

there are promotional activities in the

meeting room.

23. Many comments were concerned

about the scope of this element on

ancillary promotional activities by

supporting companies, specifically the

language on promotional activities

occurring in an obligate path to the

educational activity. These comments

asserted that this aspect of the policy

was, in general, unduly restrictive;

contrary to the normal practice of

placing exhibits in advantageous

locations; it would have a

disproportionate effect on smaller, solesponsored, local meetings to the extent

that it may make supporting companies

reluctant to fund local continuing

education activities; and it placed FDA,

inappropriately, in the position of

influencing meeting facility layout,

including routes of ingress and egress

into meeting facilities. As a

consequence, the comments argued that

certain facilities would become more or

less attractive venues for educational

activities on the basis of physical layout

alone. One comment contended that the

discussion regarding ancillary

promotional activities is overly

permissive and blurs the distinction

between independence and promotion,

which the comment viewed as contrary

to the stated purpose of the policy.

Another comment argued that the close

juxtaposition of an independent

educational activity and a promotional

activity may sharpen rather than blur

the desired distinction.

The agency is persuaded that the

language in the draft policy statement

regarding promotional activities in an

obligate path to the educational activity

should be deleted from the final

guidance. This provision is problematic

in that its application may turn on the

physical layout of a building, and thus

may favor certain facilities and

providers. Moreover, the agency is not

convinced that this is necessary to

preserve the distinction between an

independent educational activity and a

promotional activity. The agency gives

some credence to one comment’s

observation that the close juxtaposition

of an independent educational activity

and a promotional activity may be as

likely to sharpen as to blur the desired

distinction between independent and

promotional activities. Because its

contribution to preserving the

distinction between an independent

activity and a promotional activity is

uncertain, there is not adequate

justification for this provision in light of

its differential impact on affected

parties. Consequently, the final

guidance has been revised to suggest

that ancillary promotional activities

should not take place in the actual

meeting room.

24. Several comments interpreted the

draft policy statement as precluding a

sole exhibitor from having a

promotional exhibit at either a sole or

multi-sponsored educational activity.

The comments objected that this would

cause the issue to turn on whether other

exhibitors chose to exhibit.

These comments misinterpret the

draft policy statement. The provision on

ancillary promotion would not preclude

sole exhibitors from exhibiting at either

sole-sponsored or multi-sponsored

programs. The final guidance, as

revised, merely suggests that

promotional activities (sole exhibitors or

otherwise) not take place in the meeting

room. Companies are otherwise free to

exhibit at sole or multi-sponsored

programs without threatening the

independent status of the activity.

7. Objectivity and Balance and

Limitations on Data

The draft policy statement contained

two sections, entitled ‘‘Objectivity and

Balance’’ and ‘‘Limitations on Data’’ as

part of the suggested written agreement.

Under ‘‘Objectivity and Balance’’ a

provider would agree to take steps to

ensure that data are objectively selected

and presented, that both favorable and

unfavorable information about a product

are fairly represented, and that there is

a ‘‘balanced discussion of the prevailing

body of scientific information’’ about a

product and reasonable, alternative

treatment options. In ‘‘Limitations on

Data’’ the provider would agree to have

‘‘meaningful disclosure’’ of any

limitations or uncertainty on data.

Neither of these elements are included

as factors in the final guidance.

25. Several comments maintained that

these two sections would place

excessive regulatory burdens on

providers because providers would be

obliged to screen presentations in

advance and would appear to be

responsible for the behavior of

presenters who are, to an extent, beyond

the provider’s control. Other comments

argued that these sections are

inconsistent with the concept of

independence because they effectively

regulate content in an ostensibly

independent program in a manner

similar to the fair balance requirement

in FDA’s advertising regulations. Some

comments argued that these elements

are necessarily subjective in practice

and that, among other things, time

limitations, venue, and educational

objectives may influence the extent to

which a program is considered balanced

or discusses data limitations. Other
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64087

comments maintained that these

elements state only that which should

reasonably be expected in legitimate,

independent scientific discourse and

thus are not appropriately the subject of

a regulatory policy. They maintained

that having these elements as part of the

written agreement is paternalistic

because it does not credit the audience

with the intelligence and means to

require objectivity and balance and to

put presented data in its appropriate

context. Still other comments supported

these elements.

The agency is persuaded that these

elements are not necessary to help

ensure that sponsored programs are

nonpromotional and independent of the

supporting company’s influence, and

that there is adequate disclosure of

relationships and information that is

relevant to the audience’s assessment of

information presented. The agency is

also persuaded that objectivity, balance,

and disclosure of data limitations are

commonly understood to be elements of

typical, independent scientific

discourse. The agency is convinced that

these issues should be left to providers,

presenters, and accreditors of

educational activities and, therefore,

these elements are not included as

factors the agency will consider in

determining independence.

8. Discussion of Unapproved Uses

The draft policy statement suggested

that if unapproved uses are discussed,

the written agreement include an

agreement by the provider that

presenters disclose that the product is

not approved in the United States for

the use under discussion. The final

guidance states that the agency will

consider whether there is meaningful

disclosure, at the time of the program,

to the audience of whether any

unapproved uses of products will be

discussed.

26. Several comments contended that

this element is inconsistent with the

concept of an independent program,

burdensome, and would limit scientific

exchange. Several comments added that

the ultimate content of presentations is

beyond the control of providers and that

it would be cumbersome to flag

discussion of unapproved products or

uses throughout a program or

presentation. Comments from the

oncology community argued that this

aspect of the written agreement would

be especially burdensome for oncology

educational programs because it would

likely apply to the bulk of product uses

discussed. One comment suggested

using a general disclaimer in the

program materials that not all products

or product uses to be discussed are

approved uses in the United States,

rather than requiring presenters to

specifically identify those unapproved

uses.

The agency is persuaded that this

disclosure, as presented in the draft

policy statement, has the potential to be

burdensome and unwieldy in practice,

particularly in specialty areas where a

high percentage of product use is for

unapproved uses. Therefore, the final

guidance does not include as a separate

factor that providers have presenters

disclose that a particular product or use

is unapproved.

The agency, however, believes that

the fact that a program may include

discussion of products or product uses

that are not approved is a matter that

warrants disclosure. This fact, along

with acknowledgment of the supporting

company’s funding of a program, is

important to an audience’s assessment

of the information presented. The

agency believes that a less burdensome

disclosure than that proposed in the

draft policy statement would suffice.

The agency agrees with the comment

that a single, general disclosure as to

whether a program, or individual

presentations in a program, will include

discussion of products or product uses

that are not approved would be

adequate to address the agency’s

concern. Therefore, FDA has deleted the

‘‘Discussion of Unapproved Uses’’

element from the final guidance, and the

factor discussing ‘‘Disclosures’’ has been

revised to suggest that the provider

ensure meaningful disclosure, at the

time of the program, to the audience of

whether any unapproved uses of

products will be discussed. Ideally,

such disclosure should occur in

conjunction with disclosure of the

supporting company’s financial support

for the program. This disclosure could

take the form of a statement in the

program materials or be delivered

verbally at the start of the program.

27. Several comments contended that

presenters should be permitted to report

on foreign regulatory status, and

pending U.S. applications and

supplements for products discussed.

Nothing in this final guidance should

be construed as barring presenters from

discussing the foreign regulatory status

of a product, or indicating that a

product being discussed is the subject of

a pending new drug application or

supplement in the United States.

9. Opportunities for Debate

The draft policy statement included

an element that the provider agree, in

the case of live presentations, to provide

‘‘meaningful opportunities for scientific

debate or questioning’’ during the

program (57 FR 56412 at 56414). The

final guidance includes a similar factor

entitled ‘‘Opportunities for Discussion.’’

28. Several comments contended that

it is not always practical to provide

meaningful opportunities for debate

because such opportunities may be

contingent on the size of the program,

time constraints, willingness of an

audience to participate, and other

factors unrelated to a program’s

independence. These comments

maintained that an opportunity for

debate should be a goal of an

independent program, but not included

in all activities. Other comments asked

the agency to clarify what is meant by

‘‘meaningful opportunities’’ for debate.

The agency agrees that opportunities

for debate should be a goal of an

independent program, but it is not

practical or appropriate in all activities.

Factors unrelated to a program’s

independence could intercede to

preclude an opportunity for meaningful

debate. The agency’s inquiry concerning

this factor likely would be whether a

program format reasonably afforded an

opportunity for discussion, and such

opportunity was nonetheless not

provided. This finding may suggest an

intent to insulate from peer scrutiny the

data and ideas presented. As with the

other factors in this final guidance, a

finding that a meaningful opportunity

for discussion was denied may suggest

that a program was not independent

despite representations to the contrary.

Certain comments seeking

clarification of what is meant by a

‘‘meaningful opportunity for scientific

debate or questioning’’ seem to have

inferred a more stringent concept than

was intended. The goal contemplated is

no more than a reasonable opportunity

for the type of question and answer

session typical of continuing education

activities. The agency has changed the

word ‘‘debate’’ to ‘‘discussion’’ to reflect

this less structured intent.

10. Schedule of Activities

The draft policy statement suggested

that the company and provider agree to,

and record in the written agreement, the

dates, times, and locations of all

presentations (57 FR 56412 at 56414).

29. Several comments contended that

it is overly burdensome to have a

supporting company and provider

identify all presentations to be held.

They maintained that this is

problematic in that not all future

programs may be anticipated at the time

a provider and supporting company

enter into an arrangement. Several

comments maintained that the fact of

multiple presentations of the same

program should not be viewed as
64088 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

suggesting possible promotional intent

so as to warrant higher scrutiny. Some

comments argued that it is desirable to

repeat certain programs for public

health reasons, that demand for

additional programs suggests that a

program is valuable, and that repeat

presentations are desirable as they are

the most efficient way to disseminate

valuable information. Some comments

contended that there should be a

distinction between multiple programs

that were agreed to in advance of any

presentation and those that were agreed

to after the fact, and only the later

should be subject to higher scrutiny.

The agency is convinced that it may

be difficult for a supporting company

and provider to document the dates,

times, and locations of all presentations

in advance and, therefore, has removed

this element from the final guidance.

The agency, however, remains

convinced that, in some circumstances,

the fact of multiple presentations may

be an indicator of supporting company

influence. The agency agrees that

multiple presentations of the same

program are more troublesome when a

supporting company agrees to fund

additional programs after having viewed

the initial program. This opportunity to

view a program in advance of a decision

to fund additional programs provides an

obvious degree of control over content

of multiple presentations. Thus, these

programs would be viewed with greater

scrutiny.

F. Other Factors in Determining

Independence

The draft policy statement stated that

if, notwithstanding the presence of a

written agreement, a question is raised

regarding product promotion, FDA

would consider several ‘‘possible

indicia of company influence.’’ These

factors included, among others, an

examination of the relationship between

the provider and supporting company,

the provider’s involvement in the

company’s sales or marketing, logistical

assistance provided by the company, the

program’s focus (whether the program

concentrated on a single product), and

gifts to encourage attendance (57 FR

56412 at 56414). The draft policy

statement also indicated that ‘‘no

individual factor is likely by itself to

stimulate an action based on lack of

independence.’’ Many of the factors that

were discussed in the ‘‘Other Factors in

Determining Independence’’ section of

the draft policy statement (section II.B.)

have been retained in the final

guidance.

30. Several comments advised

deleting this entire section from the

policy. Another comment contended

that the articulated factors undercut the

protection afforded by the policy by

permitting post hoc review of a

provider’s decisions for indications of

possible influence.

The agency believes that it is

important to consider the actual

conduct of the parties in determining

whether a supporting company has

acted to transform an educational

activity into a promotional presentation

for its products. By including this

discussion in the ‘‘Factors Considered

in Evaluating Activities and

Determining Independence’’ (section A.

of the final guidance), the agency

believes that there will be less concern

regarding post hoc review.

1. Relationship Between Provider and

Supporting Company

The draft policy statement noted that

legal, business, or other relationships

between the company and the provider

might place the company in a position

whereby it could influence the content

of the activity. This discussion is

contained in the final guidance as a

factor the agency will consider.

31. Some comments contended that

there should be clarification of the types

of relationships that predispose a

supporting company to influence

content. Some comments argued that

‘‘influence’’ is too expansive or vague a

term, and that, a more appropriate

inquiry would be supporting company

‘‘control.’’

As discussed in response to comment

14 of section II.E. of this document, a

company-designed presentation does

not become independent merely

because it is approved by a provider

who has final editorial control. The

agency believes that ‘‘influence’’ is the

most appropriate term to describe the

basic concept of independence. The

final guidance does, however, identify

several types of relationships that may

predispose a supporting company to

influence content (e.g., legal

relationships, business relationships, a

provider that is owned by, or is not

viable without the support of the

supporting company).

32. One comment contended that

legal, business, or other relationships

should not be at issue where ‘‘a provider

has documented independence through

accreditation from a major accrediting

organization.’’

There is no basis for assuming that

accreditation of the provider by a major

accrediting organization will, in and of

itself, ensure that the provider will not

be subject to influence as a result of a

relationship with the supporting

company.

2. Provider Involvement in Sales or

Marketing

The draft policy statement listed, as

another factor in determining

independence, the provider’s

involvement in advising or assisting in

the sales or marketing of a company’s

product. The discussion in the draft

policy statement stating that

‘‘individuals who are involved in

promotion of a company’s products may

not function in the role of independent

provider, but could be selected by an

independent provider to function as a

speaker or moderator’’ (57 FR 56412 at

56414) has been deleted. The remaining

discussion is listed in the final guidance

as a factor the agency will consider.

33. Some comments identified

situations where this provision may be

interpreted so as to preclude

institutional providers and/or

companies from interacting due to

minor or unrelated involvement with

the supporting company.

The primary concern of the agency, as

reflected in the draft policy statement, is

with relationships that may affect the

provider’s independence. A relationship

between a provider member or

employee and a supporting company

will not, in and of itself, imply

influence by the company. If, however,

company employees or individuals

acting on behalf of the company are

actively involved in provider decisions

on the content of provider activities

sponsored by the company, there may

be a reason to question the provider’s

independence.

34. Some comments contended that

this provision does not adequately

distinguish between advertising

agencies involved in sales and

advertising, and communications

companies involved in education,

which also may be viewed as a

marketing function, nor does it allow for

the existence of advertising and

communications (or education)

divisions within the same company.

FDA acknowledges that certain

providers are often involved in both

promotional activities and independent

educational activities. The involvement

of a provider in both types of activities

does, however, raise questions about

whether an educational activity is, in

fact, being utilized as part of a

promotional campaign.

While the final guidance does not

preclude the use of the same provider in

a promotional effort and an independent

educational activity, such an

arrangement poses obvious difficulties.

Companies choosing to engage a

provider in both activities should be

especially concerned about the
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64089

assignment of provider personnel to the

different activities. The agency will not

ordinarily regard provider personnel

who serve as company agents for

company promotional activities to be

independent for other companysponsored scientific or educational

activities.

3. Provider’s Demonstrated Failure to

Meet Standards

The draft policy statement identified,

as a factor in determining

independence, the provider’s record of

failure to meet standards of

independence, balance, objectivity, or

scientific rigor when putting on

ostensibly independent educational

programs (57 FR 56412 at 56414). This

discussion is listed in the final guidance

as a factor the agency will consider.

35. Some comments sought

clarification as to what is meant by, or

what criteria support a conclusion of,

‘‘demonstrated failure to meet

standards’’ on the part of a provider.

Some comments contended that this is

an unworkable requirement as

supporting companies are not in a

position to know of a provider’s past

failures to meet standards in its

educational programs.

It is not unreasonable to expect due

diligence on the part of companies

when contracting with providers. In

exercising due diligence, supporting

companies should conduct a reasonable

evaluation of all information readily

available about a provider.

4. Logistical Assistance

Another factor in determining

independence contained in the draft

policy statement was the extent of

logistical assistance provided by the

supporting company. The draft policy

statement specifically mentioned that

‘‘significant contact’’ between industry

representatives and presenters might

indicate an attempt to influence a

presentation (57 FR 56412 at 56414). As

discussed in comment 36 of section

II.F.4. of this document, this discussion

has been deleted from the final

guidance.

36. Several comments argued that the

logistical assistance element was too

ambiguous a standard as it is not clear

what is meant by ‘‘significant contact.’’

Some comments argued that,

notwithstanding any ambiguity,

significant contact between a presenter

and a supporting company

representative should not be an

indicator of influence as the agency’s

inquiry should focus on actual attempts

to influence or control the content of a

presentation. They maintained that

supporting company representatives

have ongoing relationships with

presenters that would make compliance

with a generalized ‘‘significant contact’’

standard problematic.

While the agency believes that the

‘‘significant contact’’ standard is

amenable to clarification, it need not be,

as the agency is persuaded that its

inquiry concerning contacts between a

presenter and a supporting company in

conjunction with a sponsored program

should focus on attempts to influence,

rather than on volume or nature of

contacts. A supporting company, among

other factors for determining

independence, should not script, target

points for emphasis, or engage in other

activities that are designed to influence

the content of a program. The agency

believes that factor alone is adequate to

address the agency’s concern as to

contact between a supporting company

representative and a presenter in

conjunction with a sponsored program.

Therefore, discussion of the logistical

assistance provision has been deleted

from the final guidance.

5. Suggestion of Presenters

The draft policy statement

acknowledged that some providers

perceive a need to ask the supporting

company to suggest presenters. The

draft policy statement stated that if a

company suggests presenters who ‘‘are

or were actively involved in promoting

the company’s products or who have

been the subject of complaints or

objections with regard to presentations

that were viewed as misleading or

biased in favor of the company’s

products,’’ FDA might infer promotional

intent on the company’s part (57 FR

56412 at 56414). This discussion has

been incorporated, in part, into the

factor concerning ‘‘Control of Content

and Selection of Presenters and

Moderators’’ in the final guidance.

37. Some comments contended that a

supporting company may not be in a

position to know if a presenter it

suggests has been the subject of

complaints with regard to presentations

viewed as biased in favor of the

company’s products. They maintained

that this provision should expressly

indicate that supporting companies are

only accountable for knowingly

suggesting presenters that have been the

subject of such complaints.

The agency believes that the company

should be familiar with the presenter’s

background and should be willing to

make a reasonable inquiry before

recommending the name of a presenter

to the provider. In the final guidance,

this discussion has been incorporated in

the factor concerning ‘‘Control of

Content and Selection of Presenters and

Moderators.’’

38. Some comments contended that

there should be no inference of

promotional intent arising from a

supporting company’s suggestion of a

presenter who has been involved in

promoting a company’s products. They

argued that actual influence of, rather

than intent to influence, an activity is

the relevant inquiry, that the scope of

activities that may be viewed as

involvement in product promotion is

unclear, and that any relationship

between the presenter and the

supporting company can be adequately

addressed through disclosure.

The agency is concerned about the

ability of a supporting company to hire

an individual to engage in promotional

activities for the company and to

actively support the appearance of the

same individual as a presenter in an

independent educational activity

sponsored by the company. The agency

does not agree that a retrospective

finding of actual influence, which may

be extremely difficult to document, is

the relevant inquiry. The issue is

whether the company is in a position to

influence program content by suggesting

a presenter who is a paid product

promoter. The suggestion by supporting

companies of presenters selected from

their company maintained list and/or

their marketing consultants may be

viewed as an attempt to influence the

content of the program. The agency will

not ordinarily infer such intent when a

provider independently selects a

presenter who has been involved in

product promotion for a supporting

company. Disclosure cannot overcome

the lack of independence that will

ordinarily result from companies

suggesting promoters as presenters in

such programs.

6. Focus on a Single Product

The draft policy statement indicated

that one factor in determining

independence might be whether the

program content was focused on a single

product marketed by the supporting

company or a competing product except

when existing treatment options were so

limited as to preclude any meaningful

discussion of alternative therapies. The

draft policy statement noted that each

treatment option did not have to be

discussed with equal emphasis, but that

emphasis on newer or more beneficial

treatments should be provided ‘‘in the

context of a discussion of all reasonable

and relevant options’’ (57 FR 56412 at

56414). This discussion has been

incorporated in the factor concerning

the ‘‘Focus of the Program’’ in the final

guidance.
64090 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

39. Some comments contended that

focus on a single product should not be

regarded as a factor that may suggest

lack of independence, as single product

programs are useful, especially during a

product’s launch phase, and choice of

topic should be at the provider’s

discretion and should confer no

negative inference.

FDA agrees that single product

programs may be useful, especially

during a product’s launch phase.

However, the agency also recognizes

that single-product programs raise

unique concerns about the

independence of a program, because

such programs inherently lack the

presentation of competing therapeutic

modalities.

40. Several comments contended that

to suggest that a program emphasizing a

single product do so in the context of a

discussion of all reasonable and relevant

options is unreasonable or impossible

given the time constraints of a typical

educational activity.

The final guidance does not suggest

that a program emphasizing a single

product do so in the context of a

discussion of all reasonable and relevant

options. However, the agency will

consider, as one of several factors, a

program’s focus on a particular therapy

when other reasonable and relevant

options are either not discussed or are

de-emphasized.

7. Multiple Presentations

The draft policy statement indicated

that multiple performances of the same

program might result in a higher level

of agency scrutiny than singleperformance programs (57 FR 56412 at

56414). The final guidance states that

the agency will consider whether

multiple presentations of the same

program are held.

41. Several comments contended that

multiple presentations should not be

viewed as suggesting promotional intent

so as to warrant higher scrutiny. They

argued that it is desirable to repeat

certain programs for public health

reasons, that the demand for multiple

programs suggests that a program is a

valuable one, and that repeat

presentations are desirable as they are

the most efficient way to disseminate

valuable information. Some comments

contended that there should be a

distinction between multiple programs

that were agreed to before the fact and

those that were scheduled after the fact.

They contended that only the latter

should be subject to a higher level of

scrutiny.

Multiple presentations are just one of

a number of factors the agency considers

in determining the level of scrutiny to

be applied. Footnote 4 of the draft

policy statement explicitly recognized

that repeat presentations can serve

public health interests and that Public

Health Service components sometimes

actively encourage multiple

presentations on selected urgent topics.

FDA agrees that an agreement to

conduct multiple presentations arrived

at prior to commencement of the initial

presentation raises fewer questions than

an agreement arrived at after

commencement. The opportunity of a

sponsor to view the initial presentation

before agreeing to fund additional

presentations provides an obvious

degree of control over content of

multiple presentations.

42. Some comments sought

clarification of the scope of activities

that may be deemed multiple

presentations. The comments described

examples such as a single broadcast to

multiple sites via electronic media, and

a multiple presentation at a single

location for the purpose of

accommodating several nursing shifts.

A single broadcast to multiple sites

would be regarded as a single

presentation because the sponsoring

company could not apply added control

to the additional sites. Thus, the

presentation at each site enjoys an equal

degree of independence. This is only

slightly less true for multiple

presentations to accommodate several

shifts on the same day, especially when

the multiple presentations have been

contracted for in advance. Of course, the

delay might be 1 or 2 weeks to

accommodate those who might have

been on a different rotation or 1 or 2

months to accommodate newly hired

employees. FDA believes that any

increased opportunity for a sponsoring

company to deny funding for

subsequent presentations or to edit them

will raise a question with regard to

independence.

8. Gifts

The draft policy statement indicated

that one factor in determining

independence might be gifts or

inducements (other than token gifts)

provided to encourage attendance (57

FR 56412 at 56414). The final guidance

does not contain this factor.

43. One comment argued that this

provision should be deleted because it

merely duplicates the Accreditation

Council for Continuing Medical

Education (ACCME) guidelines.

ACCME-accredited programs do not

represent the full range of activities to

which this final guidance applies, and

moreover, providers of ACCMEaccredited programs may not, in all

instances, comply with ACCMEguidelines. Nonetheless, this factor has

been deleted from the final guidance

because, upon reconsideration, the

agency is not convinced that the use of

gifts or inducements to encourage

attendance is a reliable factor in

determining independence.

9. Emphasis on Noneducational

Activities

The draft policy statement indicated

that an emphasis on noneducational

activities (such as leisure or recreational

activities) would be another factor in

determining independence (57 FR

56412 at 56414). The final guidance

does not contain this factor.

44. Some comments contended that

the agency’s concern over whether the

announcement and promotion of an

educational activity focuses more on the

educational content than on leisure or

recreational activities ancillary to the

activity is vague and that the agency

should provide objective criteria for

assessing this issue. One comment

contended that this provision appears to

create a weaker standard than that of the

AMA guidelines on gifts to physicians

as it seems to indicate that a program

announcement or promotion that

focuses equally on education and

leisure would be appropriate. They

urged that the language be changed to

require that the program announcement

and promotion focus ‘‘predominantly’’

or ‘‘almost exclusively’’ on the

educational aspects of the program.

The agency continues to view the

AMA guidelines as an appropriate

standard for health care professionals.

Although the agency agrees that

program promotion, including program

announcements, should focus

predominantly on the educational

content of the program, it does not

consider greater focus on leisure or

recreational activities as reason to

believe that the program may be lacking

independence.

10. Audience Selection

Under the draft policy statement,

another factor in determining

independence was whether the

supporting company’s sales or

marketing departments generated the

invitation or mailing lists for supported

activities, or whether such lists were

intended to reflect sales or marketing

goals (such as rewards for high

prescribers of the company’s products

or to influence ‘‘opinion leaders’’) (57

FR 56412 at 56414). This discussion is

listed in the final guidance as a factor

the agency will consider.

45. Several comments objected to

limitations on supporting company

involvement in selecting or otherwise
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64091

generating audiences for educational

activities. Some maintained that

supporting company-generated mailing

lists should be permitted. Some

maintained that providers should be

permitted to enlist the aid of the

supporting company’s sales

representatives to generate audiences by

distributing program invitations, or by

other means, and that this involvement

should not suggest a lack of

independence unless a supporting

company is solely responsible for

generating an audience.

The agency continues to view

company involvement in audience

selection and/or solicitation for

attendance as undermining program

independence. The involvement of

company sales representatives in the

invitation process creates an

opportunity for a sales presentation on

the product that is likely to be discussed

at the program. This may invite a

discussion of unapproved uses in a

promotional context, thus making the

educational program a part of the

company’s promotional campaign. In

addition, supporting company

involvement in the audience selection

process invites the development of lists

that target health care professionals who

are deemed important to attend by the

supporting company. It also invites the

selection of a large number of ‘‘peer

influence’’ professionals who are likely

to be strong supporters of the company’s

products. This provides an opportunity

for bias and indirect influence on the

content of the program, and it allows the

program to be used as a promotional

vehicle for targeted health care

professionals.

46. Some comments contended that

the selection of ‘‘opinion leaders’’ as a

target audience should not raise an issue

inasmuch as such physicians are

deemed important by genuinely

independent providers as well as

companies. They argued that opinion

leaders are likely the most efficient

purveyors of information derived from

educational activities that, by their very

nature, are accessible to only a limited

number of physicians.

The focus on opinion leaders is a

standard promotional tactic to speed

acceptance of a new product so as to

more rapidly increase market share. The

agency’s understanding of educational

needs assessments by providers is that

educational programs generally are not

directed to specific opinion leaders. It is

the agency’s understanding that there is

no such policy on the part of major

accrediting organizations such as

ACCME. It is reasonable to question

whether a program that targets ‘‘opinion

leaders’’ may do so for promotional

purposes. This inference of possible

promotion, however, is only one of

many factors to be considered should a

question be raised concerning an

educational activity purported to be

independent.

47. One comment contended that

supporting companies should be

permitted to furnish providers with

complete specialty and subspecialty

mailing lists.

The agency would not object to a

supporting company furnishing a

provider with complete specialty or

subspecialty mailing lists.

11. Misleading Title

The draft policy statement indicated

that a program’s title might demonstrate

a lack of independence if the title failed

to fairly represent the scope of the

presentation (57 FR 56412 at 56414).

This discussion has been incorporated

in the factor concerning the ‘‘Focus of

the Program’’ in the final guidance.

48. One comment argued that, where

the title is under the direction and

control of the provider, it is not the

proper subject of a promotional

inference as to the supporting company.

Although the title of a program may

ostensibly be under the direction and

control of the provider, the agency has

observed that a misleading title may

reflect a lack of independence and a

desire on the part of the provider to

promote the supporting company’s

products under the guise of education.

For example, a program entitled ‘‘New

Approaches to Hypertension’’ that

focuses on a single product

manufactured by the sponsoring

company may suggest to the agency that

the program is designed to promote the

company’s product. A misleading title is

not, in and of itself, dispositive with

regard to the issue of promotional

intent. It is only one of a number of

factors to be considered by the agency.

12. Dissemination

Under the draft policy statement, if

information about the supporting

company’s product presented in the

scientific or educational activity is

further disseminated after the initial

program or publication, by or at the

company’s behest, other than in

response to an unsolicited request or

through an independent provider, this

would be another indication of possible

company influence (57 FR 56412 at

56414). This discussion has been

incorporated into the final guidance as

a factor the agency will consider.

49. Some comments maintained that

the independence of an educational

activity is enduring and that the public

health is better served by making

written, printed, or graphic program

materials readily available to health care

professionals.

Written, printed, or graphic materials

containing product information and

disseminated by, or on behalf of, a

product manufacturer are generally

viewed as promotional labeling. If, on

the other hand, the materials are

prepared and disseminated by the

provider for educational purposes, or

the materials are disseminated by the

company in response to an unsolicited

request, this would not generally be

considered as a possible indication of

company influence.

50. One comment contended that

footnote 6 of the draft policy statement

(which noted that repeat performances

are permitted when the decision is

made by the provider, possibly with

review by a nationally recognized

professional organization) should be

deleted, as it appears to be more

restrictive for repeat presentations than

other provisions in the draft policy

statement.

The agency believes that footnote 6 of

the draft policy statement is consistent

with other provisions of the draft policy

statement. As suggested in the text of

the draft policy statement, multiple

performances may cause the agency to

exercise greater scrutiny. However, a

decision made by the provider that

multiple presentations are warranted

provides some assurance that there is a

genuine professional need for repetition

of the program. Nevertheless, FDA no

longer believes that this footnote is

necessary and has deleted it from the

final guidance.

51. One comment suggested that the

reference to ‘‘publication’’ in section

II.B.5 of the draft policy statement be

struck as this appears not relevant to the

range of activities contemplated by the

policy.

FDA agrees with the comment and

has removed the reference to

‘‘publication’’ from the final guidance.

13. Complaints

Another factor for determining

independence under the draft policy

statement concerned complaints from

the provider, presenters, or attendees

regarding attempts by the company to

influence content (57 FR 56412 at

56414). This discussion has been

incorporated into the final guidance as

a factor the agency will consider.

52. Some comments contended that

complaints should be independently

substantiated before becoming a basis

for the agency inferring promotional

intent and that the agency should clarify

the mechanism for reporting

complaints.
64092 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

In general, the agency will not infer

promotional intent by a supporting

company without an investigation that

substantiates, to the agency’s

satisfaction, a complaint or allegation.

The agency declines to establish a

formal mechanism for reporting

complaints. FDA receives information

through various means, both formal (as

in requests for meetings) and informal

(such as letters and telephone calls).

The agency will exercise its judgment

and discretion in deciding whether to

take action on a complaint.

G. FDA Reliance on Major Accrediting

Organizations

The draft policy statement

acknowledged that accrediting

organizations can play an important role

in ensuring that industry-sponsored

activities are independent and

nonpromotional. The draft policy

statement indicated that FDA would

seek to rely to the extent possible on

major accrediting organizations to

monitor company-supported

educational activities conducted by

their accredited providers (57 FR 56412

at 56414). In the final guidance, this

section has been renamed ‘‘FDA’s

Cooperation With Major Accrediting

Organizations’’ and it states that the

agency will continue to work with major

accrediting organizations to monitor

company-supported educational

activities conducted by their accredited

providers.

53. Some comments questioned the

extent of FDA’s intent to rely on, and to

defer to, major accrediting

organizations.

Although FDA recognizes the

valuable role that accrediting

organizations can play in ensuring that

industry-supported educational

activities are independent and

nonpromotional, FDA cannot rely

exclusively on such organizations. The

ultimate responsibility for monitoring

inappropriate promotion in these

programs lies with FDA. Accordingly,

the final guidance has been revised to

clarify that FDA intends to work with

major accrediting organizations to

monitor company-supported

educational activities conducted by

their accredited providers.

III. Comments

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above).

Requests and comments are to be

identified with the docket number

found in brackets in the heading of this

document. Comments may be submitted

at any time and will be used to

determine whether to revise the

guidance further.

Dated: November 24, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

The text of the final guidance follows:

BILLING CODE 4160–01–F
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64093
64094 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64095
64096 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64097
64098 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 64099
64100 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

[FR Doc. 97–31741 Filed 12–2–97; 8:45 am]

BILLING CODE 4160–01–C