The Other Agency: An introduction to Pharma Marketing


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This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.

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The Other Agency: An introduction to Pharma Marketing

  1. 1. The Other Agency: How the FDA affects everything we do Presented by Dale A. Cooke @PhillyCooke Vice President/Group Director, Regulatory Review Digitas Health
  2. 2. 2 At the end of this presentation you will understand… > The role of the FDA in the development and marketing of prescription medicines > The key regulations and principles that apply to every promotion of a prescription medicine
  3. 3. 3 Setting the Stage
  4. 4. 4 Drug Development Process Clinical Trials Drug Discovery Pre-Clinical/ Laboratory Trials Phase 1 20 – 100 Subjects Safety & Dosage Range Studied Phase 2 100 – 500 Subjects Safety & Optimal Dosage/ Schedule Studied Phase 3 1,000 – 5,000 Subjects Safety & Effectiveness Studied INDFiled NDAFiled FDA Filing FDA Filing Phase 3b/4 1,000 – 5,000 Subjects Additional Safety or Efficacy Studied sNDAFiled FDA Filing
  5. 5. 5 Drug Development Process Clinical Trials Drug Discovery Pre-Clinical/ Laboratory Trials Phase 1 20 – 100 Subjects Safety & Dosage Range Studied Phase 2 100 – 500 Subjects Safety & Optimal Dosage/ Schedule Studied Phase 3 1,000 – 5,000 Subjects Safety & Effectiveness Studied INDFiled NDAFiled FDA Filing FDA Filing Phase 3b/4 1,000 – 5,000 Subjects Additional Safety or Efficacy Studied sNDAFiled FDA Filing ≈10,000 entities are studied for 1 approved drug
  6. 6. 6 Pharma Industry Success Since 1980 life expectancy for cancer patients has increased about 3 years and 83% of those gains are attributable to new treatments, including medicines. Patients diagnosed with AIDS in 1990 could expect to live only months…. Since the approval of the anti-retroviral treatments (ART) in 1995 the AIDS death rate has dropped by 78%. A 2007 study in Health Affairs found that use of antihypertensive medicines prevented 86,000 premature deaths from cardiovascular disease in 2001 and, 833,000 hospitalizations for heart attack and stroke in 2002.
  7. 7. 7 Pharma in the Headlines
  8. 8. 8 Bad Ad Program
  9. 9. 9 Increase in the number of reports of violative promotional activities from HCPs 1 1SOURCE: FDA Bad Ad Program Year End Report, 2011 Was it successful?
  10. 10. 10 Future Expansion Planned Medical SchoolsPharmacist Schools Nursing Training
  11. 11. 11 The Regulations
  12. 12. 12 What’s in a Brand Name? •Brand Name = Trade Name = Proprietary Name •Generic = Established Name Brand Name Generic
  13. 13. 13 Regulations •Featured Use “the established name…shall accompany …[brand] name…each time it is featured” •(21 CFR 202.1(b)(1)) •Body Copy if the brand name “is not featured but is used in” body copy, then the established name must accompany the brand name “at least once” [on each page] •(21 CFR 202.1(b)(1), emphasis added)
  14. 14. 14 Sample Application Featured Use Body Copy
  15. 15. 15 Logo Design •Featured Use “the [generic] name is required to be…at least half as large as …the [brand] name” • (21 CFR 201.10(g)(1) and (2); 202.1(b)(1) and (2)) “the [generic] name shall have a prominence commensurate with the…[brand] name…taking into account…typography, layout, contrast, and other printing features” • (21 CFR 201.10(g)(2) and 202.1(b)(2))
  16. 16. 16 TV Spots: Supers & Audio “[T]he [generic] name [should] be displayed on the screen for the same amount of time as the [brand] name. For superimposed text that typically runs along the bottom of the screen, the [generic] name does not have to be included…. FDA also recommends that the [brand] name be included in the audio…with the most prominent display of the proprietary name. Under most circumstances, this is the first occurrence in the broadcast.” — From Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling
  17. 17. 17 Fair Balance Prescription drug advertising must “present a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug.” - 21CFR202.1(a)(1)
  18. 18. 18 Fair Balance The Fair Balance is information that must be presented.
  19. 19. 19 Fair Balance
  20. 20. 20 Fair Balance •From the OPDP Website: Fair Balance is also a principle about how the information is presented.
  21. 21. 21 Basic Principle: Equal Prominence Fair Balance •From the OPDP Website:
  22. 22. 22 Reminder Advertising •What is it? “Reminder advertisements ... call attention to the name of the drug product but do not include indications or dosage recommendations ....” •- From 21CFR202.1.e2
  23. 23. 23 Reminder Advertising •Why does it matter? •NO Fair Balance
  24. 24. 24 Reminder Advertising •This is a reminder ad
  25. 25. 25 Reminder Advertising •This is NOT
  26. 26. 26 Reminder Advertising Why not? These are claims about the product. Taglines matter!
  27. 27. 27 Reminder Advertising •This is NOT
  28. 28. 28 Reminder Advertising Why not? Because this ran inside the magazine Turning the two communications into one product promotion
  29. 29. 29 Black Boxes •What is a Black Box? Warnings of severe possible side effects highlighted by FDA using a literal “black box”
  30. 30. 30 Black Boxes •Why does it matter? •No Reminder Advertising
  31. 31. 31 Unbranded Advertising We call these “Unbranded.” FDA calls them “Help-seeking” or “Disease Awareness” “Disease awareness communications are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.” •- Guidance for Industry "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms, FDA 2004
  32. 32. 32 Sample Help-Seeking Communication No product discussion, just disease information.
  33. 33. 33 PI vs. PPI vs. MG vs. PMI PI = Package Insert (Prescribing Information & Product Information) PPI = Patient Prescribing Information (sometimes called PI = Patient Information) MG = Medication Guide PMI = Patient Medication Information
  34. 34. PI vs. PPI vs. MG vs. PMI PI PPI MG PMI Product Class All Prescription Drugs Products with Complex Usage Products with a Safety Concern Some Prescription Drugs Who Is It Written for? Physicians Consumers Consumers Consumers Present for All Drugs? Yes No No No Document Author Product Manufacturer Product Manufacturer Product Manufacturer Pharmacy Subject to FDA Mandate? Yes Yes Yes No Dispensed with Prescription? No No* Yes Yes * Certain classes of drugs (particularly hormone treatments) have a required PPI, and for those drugs, the PPI must be distributed with every prescription.
  35. 35. 35 “Safe & Effective” •Safe > 1938 Food, Drug, and Cosmetic Act > No regulatory definition, but gain must outweigh risks •Effective > 1962 Kefauver-Harris Drug Amendments > Effective for what? > Establishes the notion of an indication > Two double-blind, placebo-controlled studies
  36. 36. 36 Off-label Promotion What is off-label promotion? > Any discussion that goes beyond the established PI Off-label usage by physicians is legal and quite common What can be done legally by pharma? > Respond to physician-initiated questions > Provide reprints of scientific research
  37. 37. Questions? Dale Cooke Vice President/Group Director, Regulatory Review @PhillyCooke on Twitter
  38. 38. 38 Dale Cooke VP/Group Director, Regulatory Review • Dale Cooke is the head of the Regulatory Review department for Digitas Health. He has worked with more than 25 pharmaceutical and medical device clients and with Medical-Legal-Regulatory committees around the world from offices in Philadelphia, New York, Boston, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is a member of the Regulatory Affairs Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI). • Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and pharmaceutical involvement in social media. • Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health. Before joining Digitas Health, Dale was with ARAMARK overseeing proposal development for government and industry clients.