Direct-to-Consumer Prescription Drug Promotion

1. Direct-to-Consumer Prescription Drug Promotion Nancy M. Ostrove, Ph.D. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration

2. Overview • What we know • law • history • stakeholder concerns • enforcement problem areas • consumer/patient perceptions • What we don’t know • broad effects on the public health

3. Background Facts • No laws or regulations ever prohibited promoting prescription drugs to consumers • Law requires advertisements to include “information in brief summary” about product’s risks and benefits • Law generally prohibits preclearance

4. Types of Advertisements - 1 • Help-seeking (“See your doctor,” disease oriented) • these are not drug ads

5. Types of Advertisements - 2 • Reminder • regulations specifically exempt from disclosure requirements • include name of product, but no representations beyond dosage form and packaging, price information • designed to remind knowledgeable persons of existence of product

6. Types of Advertisements - 3 • Product-claim -- includes • name and quantitative information • product use (indication) • optionally, other substantiated claims • risk disclosure (requirements vary as a function of whether print or broadcast)

7. Law Focuses on Content of Ads • Can’t be false or misleading • Must present “fair balance” between benefits and risk information • Can’t omit “material” facts Plain language meaning: Ads must communicate an accurate and balanced picture of the product

8. If the law allowed ads to be directed to consumers, why didn’t we see them until relatively recently?

9. Things Changed • Consumer empowerment • desire for involvement in own care • active information seeking • Aging baby-boomer population • selves, children, parents • Managed Care • Increasing focus on First Amendment

10. Evolution of DTC • Up to 1980s -- “learned intermediary” only • 1983 - 1985 -- voluntary moratorium • 1985 - regulations provide “sufficient safeguards to protect consumers” • 1990s - steady increases in print promotion • mid 1990s - broadcast increasingly enters mix

11. Broadcast Environment • Static -- sponsor uncertainty regarding requirement for “brief summary” • “Adequate provision” for providing labeling always allowed • FDA never gave guidance on “how to” • Major risks required to be disclosed regardless of mechanism

12. Result was a confusing broadcast environment -- more and more uninformative “reminder” advertisements

13. “Adequate Provision” Guidance • How to reach diverse group of consumers? • Sponsors had some suggestions • 1997 draft gave possible approach, finalized in 1999 • reference to health care provider • print ads/brochures • telephone contact number • internet site

14. Perspectives

15. Stakeholder Perspectives - 1 • DTC is good -- FDA should not over-regulate • PhRMA, individual pharmaceutical sponsors • ad agencies and associations • communications groups • media providers (print, TV, radio, internet) • Federal Trade Commission (FTC)

16. Stakeholder Perspectives - 2 • Mixed bag -- DTC may have some benefits but FDA should strictly regulate • some consumer/patient groups (e.g., National Consumers League) • some health care professional associations (AMA, ACP/ASIM, APhA) • generally want FDA to preapprove promotional materials

17. Stakeholder Perspectives - 3 • DTC is bad -- should be stopped • some consumer groups (e.g., Public Citizen, Center for Medical Consumers, National Women’s Health Network) • managed care (AMCP) • historically, generic manufacturers • Drug Enforcement Administration (DEA)

18. Focus of Arguments • Patient-physician interaction/relationship • Prescribing behavior • Patient knowledge about drugs • Product costs

19. Current Situation • Close surveillance and quick enforcement • Encourage compliance -- cooperate with voluntary requests for pre-review and comment • Assessing impact

20. Enforcement • Product efficacy claims • broadening indication, patient population • overstating or guaranteeing efficacy • implying use without disclosing risk • Disclosure of product risks • content • presentation (minimization; fair balance) • “Adequate provision” mechanism

21. What is DTC’s Impact? • Little research until relatively recently • cost concerns (correlational analyses) • effects on physician/patient relationship (self-report surveys) • FDA, Prevention, TIME Inc., NCL, AARP • effects on patients’ knowledge about drugs (experimental designs, surveys) • effects on prescribing behavior (?)

22. FDA’s Research • Patient/Physician interaction • is DTC influencing patient behavior? • 2000 - national survey of patients’ behaviors and attitudes • www.fda.gov/cder/ddmac/research.htm

23. Methodology • National probability sample • focus on patients visiting doctor in last 3 months about a problem of their own • Telephone interview (n=1,081) • Final sample • 960 who had seen doctor in last 3 months • 121 who had not

24. Demographics • More females than males; especially among those who had seen a doctor • 65% vs. 55% • Similar ethnicity and overall education among those who had and had not seen a doctor

25. Self-Reported Health

26. Do Respondents Recall Seeing Advertisements? • Asked whether they had seen an advertisement for a prescription drug in last 3 months • 72% of those who had seen a doctor • 69% of those who had not seen a doctor • Not inconsistent with 1999 Prevention survey • 81% had seen an ad (no time limit)

27. Where Was Advertisement Seen or Heard? (Multiple responses accepted) 94% 66% 29% 28% 17% 9% n = 688

28. What Information is Recalled from TV Ads? n=688

29. Information Seeking in Response to an Ad 51% 41% Has an ad for a prescription drug ever caused you to look for more information, for example, about the drug or about your health?

30. Sources of Information Cited • Mostly from health care professionals: • own doctor (81%), pharmacist (52%), nurse (33%) • Reference book (36%) • Friend, neighbor, or relative (30%) • Toll-free number, internet (both 18%) • Other print sources (magazine - 14%, newspaper - 7%)

31. How Many Read the Brief Summary? n=688

32. What if Especially Interested in the Product? n=688

33. Patient/Physician Interaction? • Patients report seeing their doctors for the traditional reasons • time for checkup (53%) • feeling ill (42%) • had symptoms (41%) • DTC not directly causing large numbers of visits • read/saw something (2%)

34. DTC Encouraging Discussion? Has an ad ever caused you to ask a doctor about a medical condition or illness you hadn’t previously talked about?

35. Awareness Influences Asking

36. How Did Doctor React? 81% 79% 71% 4% Which of these possible reactions did your doctor have when you asked about the drug? n = 220

37. Feelings About Doctor’s Reaction n=220

38. What Did Doctor Do? 50% 32% 29% 15% 14% 12% Did your doctor do one or more of the following? n = 220

39. Reason(s) Given for Not Prescribing Drug • For 59% who didn’t get requested drug prescribed, the doctor said why (n=65) • not right for patient 48% • wanted patient to take different drug 35% • side effects patient didn’t know 29% • patient didn’t have condition 23% • patient didn’t need prescription drug 20% • patient could use OTC drug 12% • less expensive drug available 8%

40. Trend Data • Annual national telephone surveys by Prevention magazine since 1997 • No change in percentage of patients asking about a specific prescription medicine as function of DTC promotion • despite large increases in funding of DTC promotion and in television advertising

41. DTC-Related Attitudes - 1(among patients) • Prescription drug advertisements: • help make me aware of new drugs 86% • give enough information for me to decide whether I should discuss with MD 70% • help me have better discussions with my MD about my health 62% • Ads make it seem like a MD is not needed to decide if drug is right for me 24%

42. DTC-Related Attitudes - 2(among patients) • Prescription drug advertisements: • help me make better decisions about my health 47% • make the drugs seem better than they really are 58% • do not give enough information about: • possible benefits and positive effects 49% • possible risks and negative effects 59%

43. Summary • Patients visiting doctors for traditional reasons • time for checkup, symptoms, feeling ill • DTC not causing large numbers of visits • DTC appears to work • awareness associated with discussing prescription medicine/specific brand with doctor • prompts information-seeking and asking about conditions not previously discussed

44. Summary • Patients think doctors reacting well to discussion about specific products • Patients think doctors denying products where appropriate; many doctors providing reasons for denial • Patients see benefits as well as risks associated with DTC advertisements

45. Limitations of Existing Research • Survey data self-report -- subject to recall and other biases • Correlational data subject to causality problem • Experimental studies to date focused on narrow issues of knowledge of particular products -- used small samples • Meaning of content analyses?

46. Remaining Questions • Regarding public health: Is DTC causing health care professionals to prescribe inappropriately? • Regarding regulation: How can DTC ads best communicate drugs’ relative benefits and risks