Direct-To-Consumer advertising: Developing evidence-based policy to improve retention and comprehension

Health Affairs

Volumn 23, Issue SUPPL., 2004, Pages

  Riggs, David L ^a   Holdsworth, Stacy M ^a   McAvoy, David R ^b  

^a ELI LILLY AND COMPANY   (United States)

^b Off of Sci and Regulatory Policy

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; CONSUMER; DRUG INFORMATION; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEALTH PRACTITIONER; INTERPERSONAL COMMUNICATION; MEDICAL INFORMATICS; MEDICAL INFORMATION; MEDICAL LITERATURE; MEDICAL RESEARCH; PATIENT EDUCATION; REVIEW; RISK BENEFIT ANALYSIS; DRUG INDUSTRY; EVIDENCE BASED MEDICINE; HUMAN; MANAGEMENT; METHODOLOGY; NOTE; UNITED STATES;

DRUG;

ADVERTISING; CONSUMER PARTICIPATION; DRUG INDUSTRY; EVIDENCE-BASED MEDICINE; HUMANS; PHARMACEUTICAL PREPARATIONS; POLICY MAKING; UNITED STATES;

EID: 4644265752     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.W4.249     Document Type: Review

References (14)

1. Food and Drug Administration, "FDA Releases Preliminary Results of Physician Survey on Direct-to-Consumer Rx Drug Advertisements," FDA Talk Paper (13 January 2003).
2. I b i d.
3. See Food and Drug Administration, "The Food and Drug Administration's Strategic Action Plan, Protecting and Advancing America's Health: Responding to New Challenges and Opportunities," August 2003, www.fda.gov/oc/mcclellan/strategic.html (5 April 2004); and FDA, "Guidance for Industry - Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Draft Guidance)" (Washington: FDA, January 2004).
4. See Food and Drug Administration, "The Food and Drug Administration's Strategic Action Plan, Protecting and Advancing America's Health: Responding to New Challenges and Opportunities," August 2003, www.fda.gov/oc/mcclellan/strategic.html (5 April 2004); and FDA, "Guidance for Industry - Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Draft Guidance)" (Washington: FDA, January 2004).
5. J.S. Weissman et al., "Physicians Report on Patient Encounters Involving Direct-to-Consumer Advertising," Health Affairs, 28 April 2004, content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.219 (28 April 2004); and S. Woloshin et al., "The Value of Benefit Data in Direct-to-Consumer Drug Ads," Health Affairs, 28 April 2004, content.healthaffairs.org/cgi/ content/abstract/hlthaff.w4.234 (28 April 2004).
6. J.S. Weissman et al., "Physicians Report on Patient Encounters Involving Direct-to-Consumer Advertising," Health Affairs, 28 April 2004, content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.219 (28 April 2004); and S. Woloshin et al., "The Value of Benefit Data in Direct-to-Consumer Drug Ads," Health Affairs, 28 April 2004, content.healthaffairs.org/cgi/ content/abstract/hlthaff.w4.234 (28 April 2004).
7. See Woloshin et al., "The Value of Benefit Data," discussion on Avastat in "Interpretations and Limitations" section, W4-242-W4-243.
8. FDA, "Guidance for Industry"; and 21 CFR, Part 202 (Prescription Drug Advertising).
9. See, for example, K. Aikin, "The Impact of Direct-to-Consumer Prescription Drug Advertising on the Physician-Patient Relationship," Presentation at FDA public meeting on direct-to-consumer promotion, Washington, D.C., 22-23 September 2003, slide 5, www.fda.gov/cder/ddmac/aikin/sld005.htm (15 April 2004). To the question, "How much of the brief summary do you read? 56 percent responded a little/none in 1999, and 73 percent responded a little/none in 2002. See also E. Slaughter, "Consumer Reaction to DTC Advertising of Prescription Medicines, 1997 to 2002," Presentation at FDA public meeting, Washington, D.C., 22-23 September 2003, www.fda.gov/cder/ddmac/ P1slaughter/index.htm (13 April 2004). In that study, 46 percent of respondents were not aware of or did not recall a brief summary.
10. See, for example, K. Aikin, "The Impact of Direct-to-Consumer Prescription Drug Advertising on the Physician-Patient Relationship," Presentation at FDA public meeting on direct-to-consumer promotion, Washington, D.C., 22-23 September 2003, slide 5, www.fda.gov/cder/ddmac/aikin/sld005.htm (15 April 2004). To the question, "How much of the brief summary do you read? 56 percent responded a little/none in 1999, and 73 percent responded a little/none in 2002. See also E. Slaughter, "Consumer Reaction to DTC Advertising of Prescription Medicines, 1997 to 2002," Presentation at FDA public meeting, Washington, D.C., 22-23 September 2003, www.fda.gov/cder/ddmac/ P1slaughter/index.htm (13 April 2004). In that study, 46 percent of respondents were not aware of or did not recall a brief summary.
11. FDA, "Guidance for Industry," 3-6.
12. PPI labeling was approved by the FDA to communicate product benefit and risk information in consumer-friendly language. For the proposed new rule, see "Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologies; Requirements for Prescription Drug Product Labels," 65 Federal Register 81082 (22 December 2000).
13. 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 in the Matter of Request for Comments on Consumer-Directed Promotion, Docket No. 2003N-0344 (2003).
14. The FDA appears to be headed in this direction. FDA, "Guidance for Industry," 3-6 ("FDA does not intend to object to a consumer-directed print advertisement for a prescription drug on the ground that it does not present risk information in compliance with the brief summary requirement.").