[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