DTC National Conference
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1 DTC National Conference Direct-to-Consumer Promotion Bob Dean DDMAC, CDER April 9, 2010
2 Direct-to-Consumer Promotion: FDA Update Annual Update on DDMAC Organizational Structure Submission Totals Review Timelines DTC Enforcements
3 The Division of Drug Marketing, Advertising, and Communications 2/23/10 Regulatory Counsel, Marissa Chaet Brykman Regulatory Counsel, Julie Burger Regulatory Counsel, Bryant Godfrey Regulatory Counsel, Ernest Voyard Labeling, Iris Masucci IT Specialist, Michael Wade Director s Office Director, Thomas Abrams Deputy Director, Kristin Davis Associate Director, Mark Askine Special Assistant, Jean-Ah Kang Program Specialist, Becki Vogt Evidence Review & Division Support, Elaine Cunningham Project Manager, Wayne Amchin Training & Support, Barbara Chong TIA, Janet Daly TIA, Sharon Smith Professional Review Group I Acting Leader Michael Sauers Professional Review Group II Leader Catherine Gray Professional Review Group III Acting Leader Lisa Hubbard Professional Review Group IV Leader Sheila Ryan Direct- To-Consumer Review Group I Leader Robert Dean Direct- To-Consumer Review Group II Leader Marci Kiester Direct-To- Consumer Review Group III Leader Sangeeta Vaswani Neurology/ Psychiatry (Amy Toscano) Cardiovascular & Renal (Emily Baker) Reproductive & Urology (Janice Maniwang) Medical Imaging & Hematology (Michelle Safarik) Oncology Drugs (JuWon Lee, Keith Olin, Karen Rulli ) Dermatology & Dental (Andrew Haffer) Pulmonary & Allergy (Roberta Szydlo) Analgesics, Anesthetics, & Rheumatology (Mathilda Fienkeng) Metabolism & Endocrinology (Samuel Skariah) Gastroenterology, Special Pathogens & Transplant (Kathleen Klemm) Anti-Infectives & Ophthalmology (Beth Carr) Antivirals (Lynn Panholzer) Oncology Biologics (Carole Broadnax, Nisha Patel) Oncology Drugs (Stephanie Victor) Metabolic/Endocrine (Kendra Jones) Derm/Dental and GI (Shefali Doshi) (Sheetal Patel) Research Team (Kathryn Aikin, Amie O Donoghue, Helen Sullivan) Cardio-renal (Zarna Patel) Neurology, Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Sharon Watson) Antivirals (Aline Moukhtara) Reproductive, Urology, Medical Imaging, Hematology, (Carrie Newcomer) Oncology Biologics (Cynthia Collins) Pulmonary and Allergy (Robyn Tyler) Psychiatry (Susannah Hubert) Anesthetics, Analgesics, & Rheumatology (Twyla Thompson)
4 DTC Review Group Dockets Direct-to-Consumer Review Group I (Robert Dean) Oncology Drugs (Stephanie Victor) Metabolic/Endocrine (Kendra Jones) Derm/Dental and GI (Shefali Doshi, Sheetal Patel) Research Team (Kathryn Aikin, Amie O Donoghue, Helen Sullivan) Direct-to-Consumer Review Group II (Marci Kiester) Cardio-renal (Zarna Patel) Neurology, Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Sharon Watson) Antivirals (Aline Moukhtara) Reproductive, Urology, Medical Imaging, Hematology (Carrie Newcomer) Direct-to-Consumer Review Group III (Sangeeta Vaswani) Oncology Biologics (Cynthia Collins) Pulmonary and Allergy (Robyn Tyler) Psychiatry (Susannah Hubert) Anesthetics, Analgesics & Rheumatology (Twyla Thompson)
5 Office of Prescription Drug Promotion? Immediate Office under the OMP Super Office 2 Divisions- professional & consumer New DTC 4 review group Enhance efforts for voluntary compliance Strengthen enforcement Decrease advisory response times Increase Guidance development
6 # of Final Promotional Pieces Submitted (2253s) ,000 80,000 60,000 40,000 20, , ,013 54,661 39,153 43,235 47, ,285 10,901 12, , Mixed Consumer Professional Total
7 Consumer 2253 Submission Trends CY2005 CY2006 CY2007 CY2008 CY2009 Internet Mailings Print Ads Broadcast Consumer Starter Kits
8 Advisory Review Goals Core Launch Materials 45 calendar days, excluding review division consults. TV ads 45 calendar days for new product, new indication, first time on TV, important safety update
9 What are Core Launch Materials? Professional 1 physician directed labeling piece (no more than 12 pages) 1 physician directed journal ad (no more than 4 pages)
10 What are Core Launch Materials? Consumer 1 comprehensive labeling piece such as a patient brochure (no more than 12 pages) 1 consumer directed journal ad (no more than 4 pages)
11 What are Core Launch Materials? Websites No more than 12 pages for Consumers No more than 12 pages for Professionals Should be similar to core sales aid or patient brochure
12 Tips for How to Submit to DDMAC Address: Food and Drug Administration Center for Drug Evaluation and Research Division of Drug Marketing, Advertising and Communications 5901-B Ammendale Road Beltsville, MD Include a DDMAC sticker or other prominent directional notation on the exterior of the package and on the cover letter itself Be sure your submission is complete Currently not accepting electronic submission of any promotional materials over the ESG
13 Tips for How to Submit to DDMAC Consult DDMAC s website prior to submitting materials ( ffices/cder/ucm htm) For time sensitive materials, please confirm receipt of the submission to DDMAC with a phone call to the project manager or appropriate reviewer ( )
14 BenzaClin NOV January 22, 2010 DDMAC issued an untitled letter to sanofi-aventis regarding claims made in a patient brochure. Overstatement of Efficacy Omission of Material Fact False or Misleading Claim
15 Can you spot a lesion?
16 Any lesion at all?
17 Look closely
18
19
20 Overstatement of Efficacy Overwhelming impression that BenzaClin will result in complete clearing of acne Clinical Study 1 total lesion counts reduced by 36% (mean), 0.2 % vehicle Clinical Study 2 total lesion counts reduced by 58% (mean), 39% vehicle
21 Aricept NOV February 3, 2010 DDMAC issued an untitled letter to Eisai Medical regarding claims made in 2 consumer broadcast ads. Overstatement of Efficacy
22 Congratulations I am granting you all honorary medical degrees Licensed and practicing Neurologists Med school refresher
23 ADAS-cog 0 to 70 Cognitive subscale of the Alzheimer s Disease Assessment Scale. Multi-item instrument that examines selected aspects of cognitive performance, including elements of memory, orientation, attention, reasoning, language, and praxis. Higher scores indicate greater cognitive impairment
24 Let s establish a baseline
25 Let s re-evaluate after treatment
26 How did your assessment compare? In clinical trials, the mean differences in the ADAS-cog change scores compared to placebo were: 5 mg/day = -2.8 units 10 mg/day = units
27 Overstatement of Efficacy The totality of the claims and presentations misleadingly overstate the efficacy of Aricept These presentations imply that, as a result of Aricept treatment, patients cognitive and daily functioning will be restored to normal
28 Dysport NOV January 11, 2010 DDMAC issued an untitled letter to Dr. Leslie Baumann regarding claims made in allure magazine, ELLE magazine, and on NBC s Today show. Promotion of an Unapproved Drug
29 allure Reloxin, the new Botox, will likely come out later this year. Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market the Botox people (Allergan) raised their price another 8 percent this year!
30 ELLE I can t wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the U.S. next year. Effects last a month longer than Botox and, hopefully, it will cost less.
31 NBC Today Show - Complaint
32 21 CFR 312.7(a) A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.
33 Overstatement of Efficacy These statements clearly suggested that Dysport was safe and effective before it was approved...and otherwise promoted the drug before it was approved (i.e., as superior to the approved product Botox).
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