Public Hearing on Direct-to-Consumer Promotion of Medical Products, November 1-2, 2005

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.

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 (PDF - 73KB)
• Agenda (PDF - 28KB)
• Transcripts
  • November 1, 2005 (PDF - 571KB)
  • November 2, 2005 (PDF - 574KB)

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

• 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-line. 
• 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.   
• 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" (PDF - 83KB) is available online.   
• 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 (PDF - 41KB)
2. Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB)
3. Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (PDF - 188KB)

• FDA conducted research to examine how DTC promotion affects the patient-physician relationship. On September 22 and 23, 2003, FDA held a public meeting at which the agency and other persons and organizations presented the results of their research on DTC promotion of prescription drugs through print, broadcast, and other types of media.  The agenda and transcripts from the public meeting are posted on the FDA Web site. 

• On November 19, 2004, FDA published the results of its research in a report titled “Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs – Summary of FDA Survey Research Results.”

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
• NTSB driving directions and map

Date created: September 19, 2005