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Direct-to-Consumer Drug Advertising
February 2004
BNA's Web Watch is prepared by Laura
Gordon-Murnane. E-mail suggestions for future weekly topics
always welcome.
Federal Government
Congress
House Government Reform Committee
A report issued Jan. 29 by Rep. Henry A. Waxman (D-Calif.)
FDA
Enforcement Actions Against False And Misleading Prescription Drug
Advertisements Declined In 2003
Letter
to FDA from Waxman
Advertisements
Cited by the Food and Drug Administration in 2003
A new investigation finds that FDA's enforcement on prescription
drug advertising continued to decline in 2003, with false or misleading
prescription drug advertisements running for months before being
cited. Jan. 29, 2004
Executive and Independent Agencies
Food and Drug Administration
Patient
and Physician Attitudes and Behaviors Associated With
DTC Promotion of Prescription Drugs — Summary of FDA Survey
Research Results Final Report (November 19, 2004)
Draft
Guidance for Industry and FDA Consumer-Directed Broadcast Advertising
of Restricted Devices
Guidance
for Industry Brief Summary: Disclosing Risk Information in Consumer-Directed
Print Advertisements
Example
of Fictional Highlights of Prescribing Information (Based on
Proposed Physician Labeling Rule)
Example
of Fictional Highlights of Prescribing Information (Based on
Proposed Physician Labeling Rule) Translated in Consumer-Friendly
Language and Formatted for Use in Consumer-DirectedAdvertisement
Guidance
for industry “Help-Seeking” and Other Disease Awareness
Communications by or onBehalf of Drug and Device Firms
Direct-To-Consumer
Promotion: Public Meeting September 22 and 23, 2003 Presentations
Meeting Transcripts
FDA/Center for Drug Evaluation and Research
Public
Hearing on Direct-to-Consumer Promotion of Medical Products
(November 1 and 2, 2005)
Transcripts
November
1, 2005
November
2, 2005
September
22, 2003 ||| September
23, 2003
The
Impact of Direct-to-Consumer Prescription Drug Advertising on the
Physician-Patient Relationship 9/25/2003
FDA
Commissioner Mark B. McClellan, Meeting New Threats With Toughened
Enforcement Standards, Speech at the National Press Club (Aug.
8, 2003).
FDA
Releases Preliminary Results of Physician Survey on Direct-to-Consumer
Rx Drug Advertisements (January 2003)
Direct-to-Consumer
Advertising of Prescription Drugs: Physician Survey Preliminary
Results
Center for Biologics Evaluation and Research
Violative
Advertising & Promotional Labeling Letters
General Accounting Office
Prescription
Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations
(Oct. 2002) (GAO-03-177).
Federal Trade Commission
Comments
of the Staff of the Bureau of Consumer Protection, the Bureau of
Economics, and the Office of Policy Planning of the Federal Trade
Commission (December 2003) Before the Food and Drug Administration:
In the Matter of Request for Comments on Consumer-Directed Promotion
(Docket No. 2003N-0344). (V040002)
Nongovernment Organizations
Kaiser Family Foundation
Demand Effects of Recent Changes in Prescription Drug Promotion
Summary
of Findings ||| Report:
The
Development of Direct-to-Consumer Prescription Drug Advertising
Regulation (March 2003)
Trends
in Direct-to-Consumer Advertising of Prescription Drugs (February
2002)
Impact
of Direct-to-Consumer Prescription Drug Advertising (November
2001)
PHARMA
Direct-to-Consumer
Advertising - Position
Medical Journals
Journal of the American Medical Association
Survey Suggesting
That Prescription Drug Ads Help Public Is Met With Skepticism
Mike Mitka JAMA. 2003;289:827.
(Requires Subscription for Full Text)
Journal of the Canadian Medical Association
How does direct-to-consumer advertising (DTCA) affect prescribing?
A survey in primary care environments with and without legal DTCA
Mintzes et al. Can Med Assoc J 2003;169:405-412
(summary)
(Requires Subscription for Full Text)
The New England Journal of Medicine
"Promotion of Prescription Drugs to Consumers: A Look at the
Numbers," by Meredith B. Rosenthal, Feb.14, 2002
(abstract
only)
The New England Journal of Medicine
Additional
articles on Direct to Consumer Drug Advertising (Requires Subscription
for Full Text)
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