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11TH ANNUAL MEETING OF ISMPP 1
1 1 T H A N N U A L M E E T I N G O F I S M P P
OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES
TO MEDICAL PUBLICATIONS April 27–29, 2015
Hyatt Regency Crystal City Arlington, VA, USA
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11TH ANNUAL MEETING OF ISMPP 2
1 1 T H A N N U A L M E E T I N G O F I S M P P
DC UPDATE: WHAT’S HAPPENING IN MEDICAL COMMUNICATION & MARKETING
AND WHAT WE CAN DO ABOUT IT
John Kamp Coalition for Healthcare Communication
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11TH ANNUAL MEETING OF ISMPP 3
First, a tribute to ISMPP: A Great Decade
• Establishing Standards of Integrity and Transparency
– Good Publications Practice for Pharmaceutical Companies
• Building on GPP to create the Steering Committee that created GPP2 and now GPP3
– The Sunshine Act Task Force • Follow financial and transparency issues in US and
globally • Understand the Act and federal rules under HHS
Open Payments Program • Provide information and tools to ISMPP members
• Establishing Standards and Best Practices – Code of Ethics in 2011 – Certification Program: The Certified Medical
Publication Professional (CMPP) credential – Code of Conduct in 2014
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11TH ANNUAL MEETING OF ISMPP 4
Tribute to ISMPP’s First Decade (continued)
• Education, advocacy and Professional Collaboration
– Annual Meetings – European & Asia Pacific Regional Meetings – Workshops – ISMPP University
• Advocacy and Collaborations – Advocacy initiative seeks to improve
understanding • Value of medical publication in research and
patient care • Value of medical publication for professionals
• Outreach activities include – Pursuing common goals with societies, e.g., ABPI,
PhRMA, BIO, Advamed – Collaborations with professional organizations, e.g.,
AMWA, EMWA, ISPOR, etc.
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11TH ANNUAL MEETING OF ISMPP 5
Tribute to ISMPP (continued)
• Medical Publishing Insights and Practices Initiative (MPIP)
– Founded in 2008 by pharma professionals and ISMPP • To develop a culture of mutual respect, understanding
and trust between journals and pharma to support transparency and dissemination of results of clinical trails
• The Global Alliance of Publication Professionals (GAPP) – Established in 2012 with global set of volunteer
industry leaders – Advocates for ISMPP members
• Responds to important media stories about the business • Publishes in peer-reviewed journals, mainstream news
media and social media • In Sum, ISMPP has lead the way in this era of increasing
transparency and data sharing through advocacy and collaborations to increase our profile, identity and authority
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11TH ANNUAL MEETING OF ISMPP 6
So, Who Are We?
AAAA
Advanstar
Association of Medical Media
AAFP
Abelson Taylor
Beacon Healthcare
Calcium USA
Concentric Pharma
Connect Healthcare Communication
Crossix
Everyday Health
Frontline/Quadrant
Havas Health
Haymarket
HMP Communications
IPG
Massachusetts Medical Society
Omnicom/DAS
Pacific Communications
Publicis Healthcare
Radius Medical Animation
Reed Elsevier
Slack
Springer
Wolters Kluwer
WebMD
WPP/Ogilvy
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11TH ANNUAL MEETING OF ISMPP 7
To promote and protect, for society and individual patients, the benefit of the free flow of healthcare information
The Coalition Mission
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11TH ANNUAL MEETING OF ISMPP 8
Significant Accomplishments • Supreme Court victory in IMS v. Sorrell protects
aggressive, innovative Rx marketing, expands industry 1st Amendment rights, prompts US v. Caronia decision
• Slows industry prosecutions, CIAs and DPAs • Undermines FDA “off label” marketing ban • Eventually will expand scope of legal “off label”
marketing • Affordable Care Act passed without Rx Marketing
Taxation • CHC and industry partners defeated three major
proposals to eliminate tax deductibility of medical communication & marketing costs
• Coordinated actions to reduce the scope of “Sunshine Act”
• CHC and industry partners limited scope of Sunshine provisions, including exclusion of certified Continuing Medical Education
• Leading efforts to dampen enforcement by HHS, including reporting of textbooks and journal reprints
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11TH ANNUAL MEETING OF ISMPP 9
• Biopharma and device companies have a First Amendment right and a social responsibility to educate healthcare providers and patients about their products
• Self-regulation is a hallmark of great communication, marketing & education
• Communication, marketing & education are just as important as R & D, and provide significant value to healthcare system
Coalition Passions
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11TH ANNUAL MEETING OF ISMPP 10
CHC Focus on Four Big Issues
• Tax Treatment of Communication/Marketing Costs
• Transparency, “Sunshine,” Conflict of Interest, Collaboration
• Privacy proposals to limit communication to professionals & patients
• FDA/HHS enforcement & emerging policies
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11TH ANNUAL MEETING OF ISMPP 11
Major Marking Issues Brewing in 2015
• Tax reform and deductibility of marketing costs
• Privacy Legislation supported by Obama Administration
• Path to 21st Century Cures – HR 293 Exempting Textbooks & Reprints from
Sunshine – Off Label Communications – One Click Away/Twitter
• HHS/CMS Policies on Sunshine • FDA Marketing Regulation • FDA Drug Approvals
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11TH ANNUAL MEETING OF ISMPP 12
Tax Reform: Retaining Tax Deductibility
• Recent Past is Prelude – House Ways & Means Committee Chair David
Camp (R-MI) – Senate Finance Committee Chair Max Baucus (D-
MO) • Impact on Advertising
• Only 50% deduction of costs allowed in year the advertising runs (vs. 100% today)
• Remaining 50% capitalized and amortized over period of 5 years (Baucus) to 10 years (Camp)
= $169 billion in captured tax revenues over 10 years (Congressional Budget Office) = 12% increase in after-tax cost of advertising in just the first three years
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11TH ANNUAL MEETING OF ISMPP 13
Prepared for Tax Action • The Ad Tax Coalition
– Meetings with members, staff in Washington – Grassroots meetings in states, districts
• CHC leaders have participated and will again • Recent meeting in Utah with Senator Orrin Hatch • Meeting today with Rep. Paul Ryan
– HIS Global Insight Studies of Economic Impact of Advertising
• Advertising helps produce 21.7 million jobs or 16% of all jobs in the United States
• Advertising helps generate $5.8 trillion or 17.2% of the United States’ economic activity
• The 4As and CHC – Letters from Leadership, including letter from heads
of over 20 CHC member organizations – Likely call for communications from you though
emails, calls and visits to Members of Congress
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11TH ANNUAL MEETING OF ISMPP 14
Data Privacy and Security • Industry must be trusted to responsibly manage
privacy data • General “Do Not Track” policies no longer gaining
momentum – Digital Advertising Alliance self-regulation blunts
efforts for legislative or regulatory action • President proposes major privacy legislation
without DNT • Health data could become exception
Bloomberg: “They know you take Viagra and want to sell you more.” Tracking medical clickstream, delivering ads
Digital Advertising Alliance reviewing standards for behavioral tracking/opt out for medical issues
Coalition coordinating meetings with IMS, Symphony Health and Crossix, inviting WebMD and Everyday Health
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11TH ANNUAL MEETING OF ISMPP 15
Path to 21st Century Cures legislation includes three communication provisions
Offered by Chairman Fred Upton (R-TX) and Congresswoman Diana DeGette (D-CO). Widespread provisions to spur medical innovation. Senate counterpart pending. Includes communication provisions that would: • 1. Exempt reprints and reference texts from reporting
under the Sunshine Act – would reverse CMS rule – House Members Michael Burgess (R-TX) and Peter
DeFazio (D-OR) introduced HR-293, to exempt peer-reviewed journals, journal reprints, journal supplements, and medical textbooks
– Senators John Barasso (R-WY) and Robert Menendez (D-NJ) planning to introduce a companion bill
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11TH ANNUAL MEETING OF ISMPP 16
21st Century Cures Legislation (continued)
• 2. Allow manufacturers to communicate new
scientific developments – including off label – to stakeholders
– Essentially recognizing the First Amendment challenges to FDA regulations
– Most controversial communication provision • 3. Reverse some FDA policies on the regulation
of social media, specifically allowing Brief Summary material to be “one click away.”
– Could greatly expand social media use by pharma
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11TH ANNUAL MEETING OF ISMPP 17
Meanwhile, changes at HHS, FDA
• “Obama will finish strong with Administration” – Aggressive administrative action countered by
contentious congressional oversight • Sylvia Mathews Burwell replaces Sebelius at top of
HHS – Focus on management, low political/Hill profile – Will press hard to finish Obama Care – Few dramatic changes in policies on Sunshine or
FDA • Commissioner Margaret Hamburg resigns
– Steven Ostroff, Acting; Robert Califf, Deputy – Stability at Center for Drugs
• Janet Woodcock, Director • John Jenkins, head of New Drugs • Tom Abrams, head of OPDP
• Drug approvals expected to be robust
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11TH ANNUAL MEETING OF ISMPP 18
Affordable Care Act lurching forward
• Current political narrative suggests ACA may be modified; but even Republican alternatives stress “repeal and replace” not just repeal
– CMS projects national drug spending to increase • 6.8% in 2014 and 6.4% in 2015 • nearly 6.5% per year from 2016 to 2023.
– Insured and Medicaid enrollment rolls up by 15 million • SCOTUS ruling on state exchanges could change
everything • Biosimilar provisions becoming reality at FDA,
incorporating complicated approval requirements and 12 year exclusivity
– Biosimilars will be branded; little relationship to generic drugs
– Novartis/Sandoz has first known biosimilar application accepted
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11TH ANNUAL MEETING OF ISMPP 19
FDA OPDP (DDMAC) New Guidance
• Evolving policy, no revolutions – FDA actively reviewing policies and promising new
guidance on social media, scientific exchange, health care economics and unsolicited requests
• 2014 social media guidance documents take small steps the right direction
– FDA clarifies “no control, no responsibility” but any control means FDA regulation applies
– Industry can correct some errors on Internet, but very carefully
– Limited promotion on Twitter & other space limited media
• February 2015 guidance on print DTC creates concept of a consumer PI, stresses consumer friendly language, Q & A and Drug Facts Box formats
– Likely application to Internet and Social Media
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11TH ANNUAL MEETING OF ISMPP 20
FDA Off Label Communication Policies Will Change Based on First Amendment Mandates • Federal Appeals Court in U.S. v. Caronia reversed criminal
conviction of pharma rep for promoting a drug “off label,”citing IMS v. Sorrell and the First Amendment
• Ruling: Truthful, non-misleading communication between rep and physician is speech protected by the First Amendment and cannot be used to jail rep for “misbranding” a drug
• Undermines regulatory basis for all FDA marketing enforcement, and many HHS IG/State “false claim” settlements
• FDA not appealing decision and slowly addressing needed changes; change inevitable but not swift
• New whistleblower case challenges most marketing prosecutions; Watch Solis v. Millennium
• PhRMA leading pressure for FDA change, calling for off label reform starting with open discussions with payers
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11TH ANNUAL MEETING OF ISMPP 21
Stay Tuned
• Industry Leader Memos from Washington – Send an email to get on the list
• Smart Brief for Healthcare Marketers – Weekly news briefs including CHC stories and
notices • Coalition Website: Cohealthcom.org • Washington Meetings • New York Meetings • Coalition filings at FDA, HHS, etc.
– Social Media Guidance Comments – TV Disclosures Comment – Sunshine Act Comments
• Political calls to action; communicating with Members of Congress to support or resist proposed bills
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11TH ANNUAL MEETING OF ISMPP 22
Meanwhile, 4 B’s from Inside the Beltway
• Be aggressive – Communicate innovations to doctors and patients – Let Washington hear your voices
• Be truthful, transparent and fully forthcoming – It’s the right thing to do – It’s the law
• Be careful – What’s legal, appropriate and expected is shifting – The law of publicity, public perceptions and public
policy • Be Proud
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11TH ANNUAL MEETING OF ISMPP 23
For Further Information
• John Kamp, Executive Director • Jack Angel, Coalition Foundation Coalition for Healthcare Communication
– (NYC) 212-850-0708 – (DC) 202-719-7216 – [email protected]
• Matt Giegerich, WPP, Chair of the Executive Committee
• Sharon Callahan, Omnicom, Secretary & Chair Elect
• Nick Colucci, Past Chair of the Executive Committee
• Donna Murphy, Treasurer
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11TH ANNUAL MEETING OF ISMPP 24
QUESTIONS?
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11TH ANNUAL MEETING OF ISMPP 25
THANK YOU
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11TH ANNUAL MEETING OF ISMPP 26
1 1 T H A N N U A L M E E T I N G O F I S M P P
OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES
TO MEDICAL PUBLICATIONS April 27–29, 2015
Hyatt Regency Crystal City Arlington, VA, USA