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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



DC UPDATE: WHAT’S HAPPENING IN MEDICAL COMMUNICATION & MARKETING

AND WHAT WE CAN DO ABOUT IT

John Kamp Coalition for Healthcare Communication


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


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.


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


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


To promote and protect, for society and individual patients, the benefit of the free flow of healthcare information

The Coalition Mission


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


• 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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


QUESTIONS?


THANK YOU



OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES

TO MEDICAL PUBLICATIONS April 27–29, 2015

Hyatt Regency Crystal City Arlington, VA, USA

OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC ... › assets › docs › Education ›...

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