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

AARP Bulletin, March 2002

03/14/02 03/13/02 FDA Is Inundated Trying To Assess Drug Ad Pitches More Than Ads, Drug Makers Rely on Sales Representatives Ad Agencies Begin to Participate In Development of New Drugs Backlash Rises Against Flashy Ads For Prescription Pharmaceuticals European Drug Makers May Utilize More Aggressive Marketing Tactics March 14, 2002March 13, 2002

FD&C Act 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

DTC Policy “Change” Draft Guidance - July, 1997 comment period closed October, 1997 Adequate Provision toll free telephone concurrent print or other availability HCP (MD, RPh, Vet.)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

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”

2002 DDMAC Letters N = 27 DTC Objections9 Medical Meeting5 Oral Statements3 Oral Statements at Hosp1 Outcomes Claims2 Web – Pre-approval1 Down from over 100 letters in previous years Seems like the same mix of topics

2002 DTC Ads Media TV/Radio5 Print4 Telephone1 FDA Objection Lack of Risk Info3 Misleading Implications4 Fact-Claim Discrepancy3 Not a Reminder2 Lots of claim interpretation objections for DTC

March 31, 2003 Ads Boost Consumer Awareness Of Drugs, but Downplay Risks. Drug makers spent almost $3 billion on consumer ads last year, about a 7% increase over 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."

April 15, 2002 ADVERTISING Patients' Success in Drug Requests Shows the Power of Medication Ads DTC

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

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

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

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

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