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Public
Hearing on Direct-to-Consumer Promotion of Medical Products
November 1 and 2, 2005
National Transportation Safety Board Boardroom and Conference
Center
429 L’Enfant Plaza, SW.,
Washington,
DC 20594
The Food and Drug Administration (FDA) will hold a public hearing to
provide an opportunity for broad public participation and comment on
direct-to-consumer (DTC) promotion of regulated medical product,
including prescription drugs for humans and animals, vaccines, blood
products, and medical devices. FDA is particularly interested in
hearing the views of individuals and groups most affected by DTC
promotion, including consumers, patients, caretakers, health
professionals (physicians, physicians' assistants, dentists, nurses,
pharmacists, veterinarians, and veterinarian technicians), managed
care organizations, and insurers, as well as the regulated
industry. FDA is seek in input on a number of specific questions,
but is interested in any other pertinent information participants in
the hearing would like to share.
Attendance Registration is Full -
Conference Center is at capacity.
10/20/2005 |
Hearing Date:
November 1 and 2, 2005
Hearing Name:
Direct-To-Consumer Promotion
Location:
National Transportation Safety Board Boardroom and
Conference Center
429 L’Enfant Plaza, SW.,
Washington,
DC 20594
Time:
9:00 a.m. -
5:00 p.m.
Federal Register
Notice of Public Meeting [TXT]
[PDF]
Agenda
Presentations
(11/9/2005)
Transcripts
Contact for Meeting
Information:
Rose Cunningham, telephone: (301) 443-5383 and fax: 301-594-5493,
email:
cunninghamr@cder.fda.gov
Written or electronic notices of participation should be submitted
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
or on the Internet at
http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
Registration is free and will be accepted on a first-come, first
served basis.
Anyone wishing to make an oral presentation during the hearing must
state this intention on the registration form. To participate,
submit your name, title, business affiliation, address, telephone
and fax numbers, and e-mail address. Please see the Federal
Register notice for further instructions.
Consolidated List of
Available DTC History Documents
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In the Federal Register of
August 16, 1995 (60 FR 42581), FDA announced a part 15 (21 CFR
part 15) hearing to be held on October 18 and 19, 1995. The agency
solicited oral testimony and written responses to a series of
questions concerning DTC promotion of prescription drugs. The
transcripts of the public meeting are available on the CDER Web
site at:
http://www.fda.gov/cder/ddmac/meetings.htm.
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In the Federal Register of May 14,
1996 (61 FR 24314), FDA published a notice making it clear that
FDA has never required preclearance of prescription product
promotion prior to use and also soliciting additional information
to help in the development of overall policy related to
consumer-directed promotion of prescription products and
restricted devices. This notice is available on FDA’s Web site
at
http://www.fda.gov/cder/ddmac/FR81695.pdf.
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In the Federal Register of
August 12, 1997 (62 FR 43171), FDA announced the availability of a
draft guidance for industry describing ways in which
consumer-directed broadcast advertisements could make "adequate
provision" for the presentation of information that would
ordinarily be provided in the brief summary of a print
advertisement. FDA revised the draft guidance and published it as
a final guidance on August 9, 1999 (64 FR 43197). The guidance and
a document entitled “Consumer-Directed Broadcast Advertisements
Guidance: Questions and Answers" is available on FDA's Web site at
www.fda.gov/cder/guidance/index.htm.
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In February 2004, FDA published a
notice of availability and requested public comment on three draft
guidances pertaining to consumer-directed promotion of medical
products. Those comments are under consideration:
(1) “Consumer-Directed
Broadcast Advertising of Restricted Devices
"
(2) “Brief
Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements”
(3) “'Help-Seeking' and Other
Disease Awareness Communications by or on Behalf of Drug and
Device Firms” [Word]
or [PDF]
The public comments on these draft
guidances are available at
http://www.fda.gov/ohrms/dockets.
Directions to the NTSB
Conference Center from METRO:
- Take METRO to L'Enfant Plaza Station
- After exiting train, follow signs to L'Enfant Plaza (Do not
follow signs to US Dept of Transportation)
- Take escalator to top and turn right; go as far as you can and
go through the glass doors on the left to enter La Promenade
- Go straight for about 200 feet and turn right
- Go straight ahead, across the atrium and continue straight
ahead until you reach the escalators by the CVS
- Take the right escalator down and turn 180 degrees left
- The NTSB Conference Center is right in front of you
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NTSB driving directions and map
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Date created: September 19, 2005, updated December 28, 2005 |
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