[Federal Register Volume 61, Number 180 (Monday, September 16, 1996)]
[Notices]
[Pages 48707-48710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0309]


Promotion of FDA-Regulated Medical Products on the Internet; 
Notice of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of a public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss issues related to the promotion of FDA-regulated 
medical products on the Internet. FDA is seeking participation in the 
public meeting and written comments from all interested parties, 
including, but not limited to, consumers, patient groups, information 
vendors, manufacturers of FDA-regulated medical products, and health 
care professionals. This meeting and the written comments are intended 
to help guide FDA in making policy decisions on the promotion of 
biologics, human and animal drugs, and medical devices on the Internet 
and the World Wide Web (the Web).

DATES: The public meeting will be held on Wednesday, October 16, 1996, 
from 8:30 a.m. to 5 p.m. and on Thursday, October 17, 1996, from 8:30 
a.m. to 3 p.m. Registration for persons who wish to actively 
participate in the discussion groups is required by October 4, 1996. 
Registration is not required for persons who wish to be in the 
audience. Written comments will be accepted until December 16, 1996.

ADDRESSES: The public meeting will be held at the Quality Hotel, 8727 
Colesville Rd., Silver Spring, MD. Individuals who wish to actively 
participate in the public meeting should mail, fax, or e-mail their 
registration information to Fay Fink (address below). There is no 
registration fee for this meeting, but registration is required for 
individuals who wish to actively participate in the group discussions. 
Seating for each discussion group is limited to 15 persons, on a first-
come, first-serve basis. Information about the public meeting is also 
available on FDA's website at http://www.fda.gov. Submit written 
comments on the questions to the Dockets Management Branch (DMB) (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. After the meeting, a transcript will be available 
at DMB (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: 
    Regarding registration: Fay Fink, Office of Policy (HF-11), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, FAX 301-594-6777, e-mail: FF[email protected].

    Regarding this notice: Ilisa B.G. Bernstein, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380, e-mail: IB[email protected]; or Melissa M. 
Moncavage, Center for Drug Evaluation and Research (HFD-40), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2828, e-mail: [email protected] or Byron L. Tart, Center for 
Devices and Radiological Health (HFZ-302), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4639, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION:

I. Background

    With the recent dramatic increases in the number of users of the 
Internet, including the Web, companies, including manufacturers and 
distributors of products regulated by FDA, are looking at the Internet 
as a medium for disseminating information about their products. FDA is 
evaluating how the statutory provisions, regulations, and policies 
concerning advertising and labeling should be applied to product-
related information on the Internet and whether any additional 
regulations, policies, or guidances are needed. Although the agency 
believes that many issues can be addressed through existing FDA 
regulations, special characteristics of the Internet may require the 
agency to provide guidance to the industry on how the regulations 
should be applied.
    The Internet is a global network of computers. The most widely used 
portion of the Internet is the Web. The Web permits the display of 
multimedia documents and objects, such as plain text, searchable 
indices, images, sounds, movies, and fill-in forms. Web pages can be 
linked to other sites on the Web using ``hypertext,'' which allows the 
user to jump to any other information page that is linked to the Web. 
The Web is where most promotion of FDA-regulated products is located on 
the Internet. In addressing promotional issues in this notice, FDA will 
use the broader term, Internet, which includes the Web.
    Since late 1995, FDA has been gathering information about the 
Internet and its utility to promote FDA-regulated products. This is in 
an effort to facilitate the development of guidance to the industry on 
the promotion of regulated products on the Internet. As part of its 
fact finding process, FDA has been meeting with companies, third party 
providers, and other groups, to gain a better understanding of the 
nature of, and the technical aspects to, promotion on the Internet. FDA 
appreciates the time and effort that these individuals, companies, and 
associations have

[[Page 48708]]

invested in assisting the agency to understand the Internet.
    In this notice, FDA is announcing two actions to get broader input 
from the public on issues related to the promotion of FDA-regulated 
products over the Internet. First, FDA is announcing a public meeting 
to discuss these issues. Second, the agency is presenting questions for 
public comment to assist in the policy development process. Based on 
discussions with the public and inquiries from regulated industry, the 
agency has identified several issues related to promotion on the 
Internet that need to be addressed. This list of issues is by no means 
exhaustive, and the agency is open to suggestions for additional issues 
to be addressed.

II. Public Meeting

    The public meeting is being held to discuss issues related to the 
promotion of FDA-regulated products over the Internet. The objective of 
the meeting is for the agency to receive broad public input and to hear 
various points of view and opinions on Internet issues from a dialogue 
among interested persons. The agency believes that a discussion group 
format would best further this goal. Therefore, the 2-day meeting will 
be conducted as a consecutive series of five discussion groups, led by 
a moderator. (Only one discussion group will be going on at a time.) A 
panel of FDA officials will listen to each discussion group and ask the 
group participants probing questions at the end of each discussion 
period. The audience will then have an opportunity to ask questions and 
comment on the topics.
    Those persons interested in actively participating in the group 
discussions should mail, fax, or e-mail their registration to Fay Fink 
(address above) including name, affiliation, address, phone number, fax 
number, e-mail address, and the discussion group(s) in which you would 
like to participate, in rank order. There is no registration fee for 
this meeting, but registration is required for individuals who wish to 
actively participate in the group discussions. Seating for each 
discussion group is limited to 15 persons, on a first-come, first-serve 
basis. FDA will attempt to balance the representation of constituents 
on the discussion groups and will attempt to give all interested 
parties an opportunity to participate in at least one group. The agency 
will maintain a waiting list in the event of cancellations or no-shows. 
The agency reserves the right to limit the number of participants from 
the same organization or company in a discussion group. The agency 
invites all other interested persons who wish to attend the meeting to 
sit in the audience during these discussion sessions. Registration is 
not required for persons who wish to be in the audience. As discussed 
earlier, there will be opportunities for persons in the audience to ask 
questions and comment on the various topics discussed.
    Prior to the meeting, the agency will distribute a list of 
questions that will be presented to each discussion group. The list of 
questions will be placed on file in the public docket (docket number 
found in brackets in the heading of this document) and will be 
available on the FDA website with the other information about this 
meeting.
    As stated previously, each discussion group will address a 
particular topic. The list of topics to be discussed during the 2-day 
meeting are as follows:
Wednesday, October 16, 1996:
    Discussion Group 1--Investigational Product Information
    Discussion Group 2--Chatrooms and Newsgroups
    Discussion Group 3--Additional Regulatory Issues
Thursday, October 17, 1996:
    Discussion Group 4--Website Links
    Discussion Group 5--International Issues
    Discussion Group 3 (Additional Regulatory Issues) will discuss 
additional issues that were not covered in the other discussion groups. 
If individuals have regulatory issues they would like addressed, which 
are not discussed in other sessions, the agency would like to include 
those topics in the discussion under Group 3. The agency invites 
interested persons to submit suggestions for discussion by this group 
by October 4, 1996. The agency will consider these suggestions and 
prepare a list of selected topics for discussion prior to the meeting. 
That list will be available in the public docket and on the FDA website 
by October 9, 1996.

III. Internet Questions

    As described above, a number of questions have arisen regarding the 
application of the advertising and labeling provisions, regulations, 
and policies to promotion on the Internet. This section will briefly 
discuss the issues the agency has identified as most frequently raised 
by regulated companies and other interested parties. It should be noted 
that although these questions may raise a particular issue, that does 
not necessarily mean that the agency will issue guidance or a 
regulation on the particular issue.

A. Presentation of Product Information

    The Federal Food, Drug, and Cosmetic Act (the act) and its 
implementing regulations define the conditions under which human and 
animal drugs, biologics, and medical devices shall be advertised or 
otherwise promoted (e.g., package insert, brief summary, brief 
statement). For prescription human and animal drugs and biologics, full 
product information (approved labeling), including indications for use, 
dosing, warnings, adverse affects, precautions, etc., shall be included 
with the dissemination of any labeling, as defined in section 201(m) of 
the act (21 U.S.C. 321(m)). (See section 502(f)(1) of the act (21 
U.S.C. 352(f)(1)) and 21 CFR 201.100(d).) For prescription human drugs, 
biological products, and prescription animal drugs, advertisements must 
contain a true statement of information in brief summary relating to 
side effects, contraindications, and effectiveness. (See section 502(n) 
of the act and 21 CFR 202.1(e).) For medical devices, any labeling as 
defined in section 201(m) of the act, including promotional labeling 
for prescription devices, must contain adequate information that 
includes indications for use, effects, routes, methods, and frequency 
of administration and any relevant hazards, contraindications, side 
effects, and precautions. (See 21 CFR 801.109.) Additionally, for 
restricted medical devices, under section 502(r) of the act, 
advertisements shall include a ``brief statement of the intended uses 
of the device and relevant warnings, precautions, side effects and 
contraindications.''
    Several companies have inquired about the application of the 
regulations and statutory provisions described above, as they relate to 
product information on the Internet. Because the agency has received 
inquiries about this issue, FDA is interested in comments addressing 
the following questions:
    1. How should product information be presented to ensure that 
Internet users will know that the product information is available and 
where it is available?
    2. Does it matter where product information is located on the 
website? If so, where should it be located?
    3. How can product information be clearly distinguished from other 
information on the Internet (e.g., disclosure statements)?
    4. Under 21 CFR 202.1(e)(5)(ii), prescription drug advertisements 
are required to present a ``* * * fair balance between information 
relating to side effects and contraindications and information relating 
to effectiveness of the drug * * *.'' Traditionally, the agency has 
interpreted this regulation such that the copy of the advertisement and 
the format of the information

[[Page 48709]]

should be ``fairly balanced.'' How should product information be 
presented on the Internet to ensure that the user has access to a 
balanced presentation of both side effects and contraindications and 
information relating to effectiveness? For example, should ``fair 
balance'' be considered in the presentation of information on every 
screen? In every advertisement or promotional piece? Or on the entire 
website?

B. Direct-to-Consumer Promotion

    Most product information on the Internet is written in technical 
language directed to health care professionals. FDA recognizes that 
many Internet users may not have the technical background to fully 
understand the language typically used in prescription drug, biological 
product, and medical device promotion.
    In the Federal Register of May 14, 1996 (61 FR 24314), FDA 
published a notice seeking public comment on several issues related to 
direct-to-consumer promotion, including whether certain FDA-approved 
patient labeling, written in language easier for consumers to 
understand, should be considered as adequate to fulfill the brief 
summary requirement for consumer-directed prescription drug and 
biological product advertisements. FDA will use the comments received 
in response to the May 14, 1996, Federal Register notice, in its 
consideration of how product information should be presented on the 
Internet. Additionally, FDA has the following questions regarding 
Internet promotion directed to consumers:
    1. Is it necessary to distinguish between promotion directed to 
health professionals and consumers on the Internet?
    2. If yes to question 1., directly above, how should websites 
clearly make the distinction between professional-directed and 
consumer-directed promotion?

C. Links Between Websites

    The Internet allows users to move easily between websites that 
provide information on many related topics. Websites can offer the user 
an opportunity to click on a topic heading (a word, word string, 
button, or icon) from a list of headings and be linked automatically to 
another location within the same website or to the website of another 
organization. Thus, it is possible for FDA-regulated industry sponsored 
websites to provide links to other sites with information about 
diseases, products, etc., some of which contain information about 
unapproved uses of approved products. Under the act, companies are 
prohibited from promoting approved human and animal drugs, biological 
products, and medical devices for unapproved uses. FDA has the 
following questions regarding links between websites:
    1. Should links from websites, posted or sponsored by a regulated 
company and containing information about FDA-regulated products be 
permitted? Why or why not?
    2. If yes to question 1., directly above, what parameters, if any, 
should be established for links from such websites to other websites, 
without violating the act.
    3. On some websites, before leaving the website to link to another 
website, the user is automatically presented with a screen that 
indicates that the user is leaving the website to go to another one. Is 
there any benefit to this type of information?

D. Investigational Product Information

    Several companies that market FDA-regulated medical products have 
inquired about the extent to which information regarding 
investigational products or investigational uses of products can be 
placed on their website. Currently, FDA regulations prohibit 
representing ``* * * in a promotional context that an investigational 
new drug is safe or effective for the purposes for which it is under 
investigation * * *'' and prohibits the ``* * * commercialization of 
the drug before it is approved for commercial distribution.'' (See 21 
CFR 312.7(a).) A similar regulation applies to investigational devices. 
(See 21 CFR 812.7.) Many companies have placed on their website 
information intended for stockholders or potential stockholders, which 
often contain information about products or uses under investigation. 
In some cases, however, it is difficult for the Internet user to 
distinguish whether the presentation of this information is intended 
for economic or promotional purposes. The agency recognizes that 
information about investigational products and uses can be useful in 
the context of scientific exchange. FDA has the following questions 
regarding investigational product information:
    To what extent should information about investigational products or 
investigational uses be presented on a sponsoring company's website? Is 
there a way to distinguish between the presentation of this information 
for economic, educational, or promotional purposes?

E. Chatrooms and Newsgroups

    Chatrooms are Internet locations where users can have ``real time'' 
conversations with other users. Newsgroups are Internet locations where 
users can post messages for other users to read and/or respond to other 
posted messages. The information discussed in chatrooms and posted in 
newsgroups is often focused on a specific issue or interest. FDA has 
the following questions on chatrooms and newsgroups:
    1. Do FDA-regulated companies maintain or sponsor chatrooms or 
newsgroups about their products, either focussed specifically on one 
product or on disease states or conditions? If so, what are the reasons 
for doing so and what is the experience to date? If not, what are the 
reasons for not doing so? What is the experience to date with respect 
to the dissemination of false or misleading information about FDA-
regulated products by noncompany users of the Internet?
    2. Should parameters be established for company participation in, 
or sponsorship of, chatrooms or newsgroups that discuss the company's 
product(s)? If so, what should they be?
    3. Some companies have expressed a desire to correct, what is in 
their belief, misconceptions or misinformation about unapproved uses of 
their products, which may be presented in chatrooms and newsgroups. 
Some of these companies have stated that they have not corrected the 
information in the belief that they could be considered promoting the 
unapproved use. Should such information be regarded as violative 
promotion? Are there any parameters or criteria that could be used to 
determine the appropriateness or scope of such corrections.

F. International Issues

    FDA has heard from some multinational pharmaceutical, biologic, and 
device companies that wish to centralize their Internet product 
information dissemination from one server within the United States. 
Under the act and current regulations, however, companies may not 
advertise or otherwise promote their approved or unapproved products 
within the United States for uses that are not approved in this 
country. A company's products may be approved in other countries, but 
not in the United States, or may be approved in the United States, but 
for different uses in other countries. Consequently, companies could be 
considered promoting unapproved products or uses in the United States 
by disseminating information about products approved in foreign 
countries to U.S. citizens. FDA has the following questions on 
international issues:

[[Page 48710]]

    1. How could promotion of products manufactured or distributed by 
multinational companies be presented on the Internet without violating 
the act and regulations?
    2. What factors should FDA consider in determining whether a 
company is attempting to promote a product within the United States, 
which is approved for a use in another country, but not so approved in 
the United States?
    3. What policies and regulations have other countries established 
or are considering with respect to the dissemination of information 
about medical products over the Internet?
    FDA welcomes comments on all of the issues described above.

    Dated: September 10, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-23616 Filed 9-13-96; 8:45 am]
BILLING CODE 4160-01-F