Anthony Genovese Bayer HealthCare October 9, 2014

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Hubert Andrews
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1 Anthony Genovese Bayer HealthCare October 9, 2014

2 Disclaimer The view and opinions expressed here today are the views of the author and do not necessarily reflect the official policy or position of Bayer.

3 Overview What is DTCA? History of DTCA Different types of DTC Advertisements Pros and Cons DTC Spending U.S. DTC Regulation Enforcement

4 What is Direct-to-Consumer Advertising? Also known as DTC Pharmaceutical company s promotion of prescription drugs Aimed at a general audience (consumers) Appear on TV and radio, in magazines and newspapers, and also online

5 QUIZ 1. Q - What other countries allow DTC Advertising? A - NEW ZEALAND 2. Q - How much money was spent by the US pharmaceutical industry in 2012 on DTC advertising? A - $3.5 BILLION 3. Q - FDA approves DTC advertisements? True or False? A - FALSE

6 History of DTCA 1950s - early 1980s Pharmaceutical ads directed to medical personnel First DTC television ad for Boots Pharmaceuticals Rufen (ibuprofen) aired in 1981

History of DTC 1983 1985 DTCA suspended so FDA could create a more explicit policy 1997 FDA revised rules allowing drug companies to use drug s

9 History of DTC DTCA suspended so FDA could create a more explicit policy 1997 FDA revised rules allowing drug companies to use drug s brand name and describe the drug s benefits within the same advertisement Prior to 1997, drug companies were permitted to mention the drug s name only

10 1st D-T-C Rx drug ad in US FDA requests voluntary Moratorium FDA issues Guidelines FDA relaxes rules governing TV ads DTC SPEND = $3.5B

11 Types of DTCA Product Claim Help-seeking Reminder

12 Product Claim Advertisements Most common form Includes brand name Makes claims regarding safety and efficacy Describe risks and benefits Information about benefits and risks of product must be presented in fair balance Mirena Product Claim Commercial

13 Help-Seeking Advertisements Describe disease or medical condition Does not discuss or mention drug name Describes a disease or medical condition No claims of drug are made No requirement for risk information Purpose is to encourage people with particular symptoms to consult with their doctor Viagra Ad

15 Reminder Advertisements Names a drug and dosage form Does not include uses/treatment Does not make claims about the product Reinforces brand name and brand loyalty Arbitraer Reminder Ad

17 Pros of DTCA Pros of DTCA video Educates consumers about disease/medical conditions and available treatments Meets increasing demand for medical information/treatments Encourages people to seek treatment for conditions or symptoms that might otherwise go untreated Helps remove stigma associated with certain diseases and medical conditions (e.g., ED) Ultimately reduces costs to healthcare system by prompting early diagnosis and treatment

18 Cons of DTCA Cons of DTCA video Patients are misinformed and request a prescription for an illness they may not have Encourages self-diagnosis belief that treatment is needed, when really not Promotes drug use before long-term safety information is known Physicians feel pressured to prescribe a particular medication. (continued)

19 Cons of DTCA (continued) Encourages over-medication Weakens relationship between patient and doctor Promotes medical conditions that are not medical conditions Questionable medical need - Latisse Ad

20 The spending by the top 20 companies represents adds up to about $3.6 billion or 95% of the entire 2013 DTC spend, which was $3.8 billion (including Internet display ad spend).

21 Regulatory Oversight FDA has primary jurisdiction over the advertising of prescription drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) The Office of Prescription Drug Promotion (OPDP) within the FDA's Center for Drug Evaluation and Research (CDER) is responsible for implementing the regulations governing DTC advertising

22 What are the Underlying Rules? Ads must be truthful and not misleading (not false or misleading ) provide a fair balance between information about effectiveness and about risks Be consistent with the approved product labeling, or the package insert (PI) Only include claims substantiated by adequate and wellcontrolled clinical studies include facts material in light of how the product is promoted include information in brief summary relating to the product s risks and benefits (or PI if labeling)

23 How Does FDA Enforce these Rules? Advisory Comments Provide comments on DRAFT promotional materials (VOLUNTARY in most cases) Launch materials for new drugs or new indications Direct-to-consumer (DTC) broadcast ads Non-launch materials Pre-submission required for certain drugs (e.g., Subpart H/Subpart E accelerated approval )

24 How Does FDA Enforce these Rules? Surveillance and Enforcement Required submission of promotional materials at time of initial use Form 2253 (21 CFR (b)(3)(i)) Complaints from competitors, HCPs, consumer groups and individuals Bad Ad program Active surveillance professional journals, magazines, TV, conference attendance

25 Consequences of Violations Regulatory untitled letter (NOV or notice of violation) Warning Letter injunction, seizure, or prosecution Other potential consequences bad publicity embarrassment, effects on stock prices, Congressional scrutiny follow-on criminal or civil lawsuits

26 Epipen/EpiPen Jr. Pfizer Inc. Background: EpiPen and EpiPen Jr are indicated in emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects... allergen immunotherapy, foods, drugs, diagnostic testing intended for immediate self-administration as emergency supportive therapy only and are not a substitute for immediate medical care. FDA Warning Letter (May 2012): Max s Birthday Party TV Ad Revised TV ad:

27 Voltaren DTC MINIMIZATION OF RISK Efficacy claims in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space Risk information is relegated to the bottom of the in singlespaced paragraph format that makes the information difficult to read TOP OF BOTTOM

28 Voltaren DTC BROADENING OF INDICATION Misleading because it suggests that Voltaren Gel is useful on any kind of joint pain caused by OA when this is not the case Full indication in small font under Important Safety Information, which appears at the bottom of the . would not appear on viewers screen at the same time as the headline claim

Regulation of Prescription Drug Promotion

Regulation of Prescription Drug Promotion Amy Toscano, Pharm.D., RAC, CPA Team Leader Office of Prescription Drug Promotion Food and Drug Administration June 2013 Overview Office of Prescription Drug Promotion