Marketing Pharmaceuticals in a Time of Change

Transcription

1 Member Early-bird Rate Register by February 2 and Save $250 21st Annual DIA Conference on Marketing Pharmaceuticals in a Time of Change Tutorial: February 23, 2009 Conference: February 24-25, 2009 New York Marriott Marquis, New York, NY,USA PROGRAM COMMITTEE WAYNE L. PINES THOMAS W. ABRAMS, MBA, RPh Director, Division of Drug Advertising, Marketing and, GLENN N. BYRD, MBA, RAC Director, Regulatory Affairs, MedImmune, Inc. JOHN F. KAMP, JD, PHDP Executive Director, Coalition of Healthcare Communication LUCY ROSE, MBA National Managing Director, Life Sciences, Regulatory and Capital Markets Consulting, Deloitte & Touche, LLP MINNIE BAYLOR-HENRY, JD Regulatory & Capital Markets Consulting Deloitte & Touche LLP KRISTIN I. DAVIS, JD Deputy Director, Division of Drug Marketing, Advertising and, PROGRAM HIGHLIGHTS FDA Update: Recent Enforcement Actions DTC Update from DDMAC Enforcement Updates: New Trends in State and Federal Enforcement Ethics in Marketing Pharmaceuticals: Panel Discussion Current and New Trends in DTC Promotion Global Promotion Efforts of Pharmaceuticals Hot Topics Question and Answer with FDA WHO SHOULD ATTEND This program is designed for individuals involved in marketing, legal, regulatory, public relations/ affairs, advertising, compliance and management in pharmaceutical, veterinary medicine, biologics and medical device companies and organizations. Consultants in the areas of advertising, public relations, legal and marketing communications are also encouraged to attend. CONFERENCE CONTACT INFORMATION Ellen Diegel, Program Manager Phone Ellen.Diegel@diahome.org OVERVIEW This program is designed both for people who are new to advertising and promotion issues, as well as those who have been involved in this area for some time. It is designed to provide a basic understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals. It also provides practical, day-to-day guidance on what can be learned from the latest FDA enforcement actions, and how companies can do their jobs better. This year s program focuses on enforcement by the three centers within FDA that regulate drugs, biological products and veterinary drugs, direct-to-consumer advertising, state regulations, and the oversight of off-label issues by the Office of Inspector General and Department of Justice. The session also will explore the latest innovations in the use of the internet for product communication. LEARNING OBJECTIVES: At the conclusion of this conference, participants should be able to: Identify the trends reflected in the latest enforcement actions and policies by the FDA Summarize best practices by other companies in implementing regulatory policies Describe how companies can best navigate the regulatory review process at FDA Outline the policies and actions being taken by others, such as OIG, DOJ and trade and professional associations Monday, February 23 TUTORIAL INSTRUCTOR: LUCY ROSE, MBA National Managing Director, Life Sciences Regulatory and Capital Markets Consulting, Deloitte & Touche, LLP If you are new, or relatively new, to DDMAC and/or advertising/promotional compliance, this tutorial is for you!! The leaders will provide a strong introductory foundation for anyone working in our new regulatory environment. Whether you are a regulatory, legal, medical, or marketing professional, the information will be interesting, practical and vital! Tutorial Learning Objectives: At the conclusion of this tutorial, participants should be able to: Discuss the latest regulations, enforcement actions, guidelines, and trends affecting the advertising and promotion of medical devices, drugs, and biologics Describe how companies can best navigate the FDA regulatory review process Provide an overview of the current direct-to-consumer advertising/promotion environment Outline the latest policies and actions being taken by the Office of Inspector General (OIG) and Department of Justice (DOJ) Summarize the FDA s claim support and fair balance regulatory requirements Facilitate proper promotional practices at medical meetings Comply with interactive communications regulations on the Internet Present best practices in sales force and speakers bureau monitoring Recognize regulatory/compliance challenges associated with public relations and disease state programs Tutorial Target Audience This program is designed for individuals involved in marketing, legal, regulatory, public affairs, and advertising executives in the pharmaceutical and biologics industries, plus their consultants and agencies. If you are relatively new to this area, please join our experienced experts to gain the important information you need to maximize your conference learning! VISIT FOR A COMPLETE % SCHEDULE OF EVENTS! DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: fax: dia@diahome.org

2 Accreditation and Credit Designation The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a Provider of continuing pharmacy education. This conference is designated for up to contact hours or continuing education units (CEUs) to participants who successfully complete this program and tutorial L04-P. The Drug Information Association (DIA) has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA DIA is authorized by IACET to offer up to 1.5 CEUs for this program and tutorial. Tutorial:.3 IACET CEUs Conference: 1.2 IACET CEUs To receive a statement of credit, please visit Detailed instructions on how to complete your credit request and download your certificate will be provided onsite. Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be included in the course materials. Please see front cover for Learning Objectives. Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA. MONDAY FEBRUARY 23 TUESDAY FEBRUARY 24 12:30-1:30 PM REGISTRATION 1:30-5:00 PM TUTORIAL INSTRUCTORS Lucy Rose, MBA National Managing Director, Life Sciences Regulatory and Capital Markets Consulting, Deloitte & Touche, LLP Paul Savidge, JD Vice President, Labeling and Promotion, Bristol-Myers Squibb Kelly Freeman, PhD Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company If you are new, or relatively new, to DDMAC and/or advertising/promotional compliance, this tutorial is for you!! The leaders will provide a strong introductory foundation for anyone working in our new regulatory environment. Whether you are a regulatory, legal, medical, or marketing professional, the information will be interesting, practical and vital! Tutorial Learning Objectives Please see front cover Tutorial Target Audience This program is designed for individuals involved in marketing, legal, regulatory, public affairs, and advertising executives in the pharmaceutical and biologics industries, plus their consultants and agencies. If you are relatively new to this area, please join our experienced experts to gain the important information you need to maximize your conference learning! 7:15-8:15 AM REGISTRATION AND CONTINENTAL BREAKFAST 8:15-8:30 AM WELCOME AND OPENING REMARKS 8:30-9:00 AM KEYNOTE PRESENTATION THE CRITICAL PATH INITIATIVE: DRIVING INNOVATION THROUGH COLLABORATION Rachel Behrman, MD Associate Commissioner for Clinical Programs US Food and Drug Administration 9:00-10:30 AM SESSION I FDA UPDATE: RECENT ENFORCEMENT ACTIONS This session provides an overview on current issues, laws and regulations to the promotion of prescription drugs. Learn the latest on policy development, enforcement and FDA s future initiatives. CDER UPDATE Thomas W. Abrams, MBA, RPh Director, Division of Drug, Advertising, Marketing and 5:00-7:00 PM GENERAL SESSION REGISTRATION CBER UPDATE Elenita Ibarra Pratt, RN, MPH Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality CBER, FDA 2

3 CVM UPDATE Speaker has been invited QUESTIONS AND ANSWERS 10:30-10:45 AM REFRESHMENT BREAK 10:45 AM -12:15 PM SESSION II DTC UPDATE FROM DDMAC Deputy Director, Division of Drug Marketing, Advertising and DTC promotion continues to be one of the most visible and politically charged issues for the pharmaceutical industry. This panel will examine DTC television ads, FDA policies and research, and provide practical advice on how to interact with the FDA with its review program. Deputy Director, Division of Drug Marketing, Advertising and Marci Kiester Leader, DTC Review Group, Division of Drug, Advertising, Marketing and Kathryn Aikin, PhD Social Science Analyst, DTC Review Group Research Team, Division of Drug Marketing, Advertising and Communications (DDMAC) QUESTIONS AND ANSWERS 12:15-1:30 PM LUNCHEON (NO LUNCH SPEAKER) 1:30-3:00 PM SESSION III ENFORCEMENT UPDATES: NEW TRENDS IN STATE AND FEDERAL ENFORCEMENT Lucy Rose, MBA National Managing Director, Life Sciences Regulatory and Capital Markets Consulting Deloitte & Touche, LLP This session will focus on trends in state and federal enforcement and the changes inside the industry in response to them. Several states have developed new laws regulating drug company marketing, including use of prescriber data, limits on interactions with doctors and formulary groups, and new reporting requirements. Meanwhile, both state and private actions have increased. Meanwhile, federal enforcement by the HHS-IG and Department of Justice has created a new focus on the need for internal controls and investigations. Paul Savidge, JD Vice President, Labeling and Promotion Bristol-Myers Squibb John Oroho, JD Principal Porzio, Bromberg & Newman Additional speaker has been invited 3:00-3:30 PM REFRESHMENT BREAK 3:30-5:00 PM SESSION IV MANAGING INDEPENDENT CME GRANT SUPPORT: PROTECTING PATIENT CARE AND PHYSICIAN EDUCATION WITHOUT VIOLATING THE LAW John F. Kamp, JD, PhD Executive Director, Coalition for Healthcare Communication, and, Of Counsel, Wiley Rein LLP Three pharmaceutical company CME leaders will discuss the evolving controversies around industry funding of independent continuing medical education for health care providers. These companies have developed CME grant programs that comply with FDA policy and corporate integrity agreements (CIAs) and other settlements with law enforcement agencies. In additions, speakers will address the evolving policies of the Accreditation Council for Medical Education (ACCME). Speakers also will discuss internal staffing and organization, particularly in relation to the marketing departments. Understand the differences between promotion and independent CME, and the need to separate the grants process from marketing. Increase knowledge of the evolving public policy controversies involving education and conflict of interest Understand the evolving "transparency" issues leading to full disclosure of all payments to physicians, including evolving state and federal requirements Pamela L. Mason, FACME, CCMEP Director, Medical Education Grants AstraZeneca Pharmaceuticals Hilary J. Schmidt, PhD Associate Vice President, Medical Education sanofi-aventis Jennifer Spear Smith, PhD, FACME Executive Director, Professional Education Support, Wyeth Pharmaceuticals 5:00-6:00 PM RECEPTION WEDNESDAY FEBRUARY 25 7:30-8:30 AM REGISTRATION AND CONTINENTAL BREAKFAST 8:30-10:00 AM SESSION V THE WHO, WHAT & HOW OF ONLINE & MOBILE TECHNOLOGIES IN HEALTHCARE TODAY Liz Kay VP, Account Services, Healthcare Practice Cramer The Internet era has brought profound changes on the ways in which both doctors and patients find and use information to support medical decisions. With more than 113 million Americans searching for healthcare information online, the time is now to understand the impact of this transformation and learn how each of us are impacted by these changes. This session will discuss some of the latest online innovations, mobile technologies and Best Practices in pharmaceutical marketing and communications. It will include industry experts addressing these issues for both healthcare professionals and patients. Time for open dialogue will be included. 3

4 Craig DeLarge Associate Director of e-marketing Novo Nordisk Darren Ross Executive Vice President, Digital Marketing Cramer Mark Bard President Manhattan Research 10:00-10:30 AM REFRESHMENT BREAK 1:30-3:00 PM SESSION VII HOT TOPICS This session will focus on the latest hot topics that affect promotional activities, including the implementation of the revised PhRMA Code, FDA policy on the distribution of peer-reviewed reprints from medical journals, the latest status of industry's role in CME, and global initiatives. 10:30-12:00 PM SESSION VI PROMOTING TO SUBSETS OF THE GENERAL POPULATION: IT S MORE THAN TRANSLATION Minnie Baylor-Henry, JD Regulatory & Capital Markets Consulting, Deloitte & Touche LLP The Food and Drug Administration Amendments Act of 2007 (FDAAA) states that 24 months after implementation, there needs to be a report on direct-to-consumer advertising and its ability to communicate to subsets of the general population, including elderly populations, children, and racial and ethnic minority communities. The opportunity for companies is to move beyond core promotional pieces that have been either translated into another language, often Spanish, or that simply add some racially diverse or elderly actors and conclude that the promotional piece now targets a certain population. Does changing the language or actors fully convey the message? This interactive panel will examine the appropriateness of a one core piece fits all approach and evaluate whether such pieces are, in fact, misleading, if they fail to adequately convey the benefits and risks information in a manner that can be understood by the targeted audience. It will also provide some tips for reaching subsets of the general population. PANEL Jose F. Sosa Director, State Government Relations Johnson & Johnson Dorothy Wetzel Consumer Health Care Consultant An FDA speaker has been invited PHRMA CODE Diane E. Bieri Executive Vice President and General Counsel Pharmaceutical Research and Manufacturers of America (PhRMA) PEER REVIEW REPRINTS GUIDANCE Alan Bennett Partner, Ropes & Gray Additional speaker has been invited 3:00-3:30 PM REFRESHMENT BREAK 3:30-4:30 PM SESSION VIII QUESTION AND ANSWER WITH FDA Glenn Byrd, MBA, RAC Director, Regulatory Affairs, MedImmune, Inc. Use this unique opportunity to bring your pressing questions for FDA to address in person. This session will attempt to answer any remaining questions from earlier sessions and to allow the audience to ask new questions to our FDA speakers. PANEL Thomas W. Abrams, MBA, RPh Elenita Ibarra Pratt, RN, MPH Marci Kiester Kathryn Aikin, PhD 12:00-1:30 PM LUNCHEON (NO LUNCH SPEAKER) 4:30-4:45 PM CLOSING REMARKS AND ADJOURN TRAVEL AND HOTEL La Guardia, Kennedy, and Newark Airports are conveniently located and airline reservations should be made as early as possible to ensure availability. Amtrak s Penn Station is located several blocks from the New York Marriott Marquis. For Amtrak reservations, call USA- RAIL. The New York Marriott Marquis is holding a block of rooms at the reduced rate below until January 30, 2009, for DIA meeting attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single $285 Double $285 Please contact the New York Marriott Marquis by telephone at or and mention the DIA event. The hotel is located at 1535 Broadway, New York, NY 10036, USA. GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA. 4

5 Drug Information Association MEMBER EARLY BIRD Register by February 2, 2009 SAVE $250 21st Annual Conference on Marketing Pharmaceuticals in a Time of Change Event ID #09007 New York Marriott Marquis New York, NY USA FEBRUARY 23-25, 2009 Monday, February 23 TUTORIAL INSTRUCTOR: LUCY ROSE, MBA National Managing Director, Life Sciences Regulatory and Capital Markets Consulting Deloitte & Touche, LLP Register online or fax this page to CONTACT INFORMATION Contact Ellen Diegel at the DIA office by telephone , fax or Ellen.Diegel@diahome.org. DRUG INFORMATION ASSOCIATION 800 Enterprise Road, Suite 200 Horsham, PA USA GROUP DISCOUNTS (not available online or on already discounted fees) Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time no exceptions. See page 4 for complete details. Registration Fees If DIA cannot verify your membership upon receipt of registration form, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. MEMBER EARLY-BIRD OPPORTUNITY On or before After Available on nondiscount member fee only. FEB. 2, 2009 FEB. 2, 2009 Member Fee US $1375 US $1625 Join DIA now to qualify for the early-bird MEMBERSHIP member fee! US $ 130 AboutMembership/AboutMembership To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. Nonmember Fee US $1755 A one-year membership to DIA is available to those paying a NONMEMBER registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. I want to be a DIA member I do NOT want to be a DIA member Discount Fees MEMBER NONMEMBER* Government (Full-time) US $ 395 US $ 525 Charitable Nonprofit/Academia (Full-time) US $ 815 US $ 945 *If paying a nonmember fee, please check one box above, indicating whether you want membership. TUTORIAL February 23 DDMAC and Compliance 101: A Primer US $ 405 CANCELLATION POLICY: On or before FEBRUARY 16, 2009 Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Government or Academia or Nonprofit (Member or Nonmember) = $100 Tutorial (if applicable) = $50 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. I cannot attend but please keep me informed of DIA s future events. (requires completion of name, postal address and address on this form) Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. REGISTRATION FORM Do not remove mailing label. 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