Regulatory & Public Health Implications of DTCA

1. Regulatory & Public Health Implications of DTCA Economists Conference Louis A. Morris, Ph.D. April 29, 2003

2. AARP Bulletin, March 2002

3. AARP Bulletin, March 2002

4. 03/14/02 03/13/02 03/13/02 March 13, 2002 March 14, 2002 More Than Ads, Drug MakersRely on Sales Representatives Backlash Rises Against Flashy AdsFor Prescription Pharmaceuticals Ad Agencies Begin to ParticipateIn Development of New Drugs FDA Is Inundated TryingTo Assess Drug Ad Pitches European Drug Makers May UtilizeMore Aggressive Marketing Tactics

5. FD&C Act - 1962 Amendments • Advertisements and Labeling • must contain a true statement of the drug’s intended uses • cannot be false or misleading • must contain a brief summary • Regulations • fair balance • contextual • overall

6. DTC Policy “Change” • Draft Guidance - July, 1997 • comment period closed October, 1997 • Adequate Provision • toll free telephone • concurrent print or other availability • HCP (MD, RPh, Vet.) provide information • Internet • Presumes Major Statement

7. FDA Letters: 8 Pitfalls of DTCA • Reminder/Institutional • Implied Claims • Disclosure Adequacy • Contextual Fair Balance • Limits on Effectiveness • Overall Fair Balance • Unsubstantiated Claims • Distractions “RID the CLOUD”

8. 2002 DDMAC Letters • N = 27 • DTC Objections 9 • Medical Meeting 5 • Oral Statements 3 • Oral Statements at Hosp 1 • Outcomes Claims 2 • Web – Pre-approval 1 Down from over 100 letters in previous years Seems like the same mix of topics

9. 2002 DTC Ads • Media • TV/Radio 5 • Print 4 • Telephone 1 • FDA Objection • Lack of Risk Info 3 • Misleading Implications 4 • Fact-Claim Discrepancy 3 • Not a Reminder 2 Lots of claim interpretation objections for DTC

10. March 31, 2003 Ads Boost Consumer AwarenessOf Drugs, but Downplay Risks. Drug makers spent almost $3 billion on consumer ads last year, about a 7% increase over 2001. And consumers generally like them, notwithstanding some suspicions that the ads inflate drug costs, surveys show. But doctors, regulators and consumer advocates continue to have concerns. A survey of 500 doctors conducted by the FDA last year and presented at the conference asked whether consumer drug ads confused patients about the relative risks and benefits of medicines. Some 70% of general practitioners and 60% of specialists answered "somewhat" or "a great deal." Only 5% of general practitioners and 10% of specialist said "not at all."

11. April 15, 2002 Patients' Success in Drug RequestsShows the Power of Medication Ads ADVERTISING DTC

12. Beneficial Effects – MD Survey Did the fact that this patient saw an advertisement have any beneficial effects for your interaction with this patient? N = 459 Aiken, 2003

13. What beneficial effects did it have? Percent Aiken, 2003 N = 187

14. Problems Did the fact that this patient saw an advertisement create any problems for your interaction with this patient? N = 459 Aiken, 2003

15. What problems did it cause? Percent Aiken, 2003 N = 187

16. Current Views of DTC • Surveys show few Benefits, few Problems • Risk Communication – balance a key issue • Suggestion to pay into consumer education “pot” • DTC remains heavily regulated • Implied Claims often focus of objection • FDA regulation is mitigated by GC review • Doctors still skeptical • Still despised by MCOs and payers • Risk Management Issue • Forteo (Lilly), no DTC