John F. Kamp, JD, PhD
Executive Director of the Coalition for Healthcare Communication
Dr. John F. Kamp is Executive Director of the Coalition for Healthcare
Communication, a drug marketing group with offices in New York City
and Washington, DC. He is also of counsel with the law firm Wiley Rein
LLP, and is a well known advocate for First Amendment rights of
individuals and corporations. His professional experience includes 10
years with the Washington, DC, office of the American Association of
Advertising Agencies and nearly a decade in public policy positions at the Federal
Communications Commission (FCC). Before moving to Washington, Dr. Kamp taught journalism
at the University of Iowa and at Tulsa University.
Dr. Kamp earned his bachelor s degree at the University of Notre Dame, his doctorate from the
University of Iowa School of Journalism in Iowa City, and his juris doctorate at the University of
Tulsa School of Law.
Dr. Kamp is a frequent speaker at industry meetings on ethical, legal, and political issues
surrounding drug marketing, and is recognized as an authority in these issues by the print and
broadcast press. He serves on the public advisory committees of the American Academy of
Family Physicians and Medscape. He is on the editorial boards of the Rx Compliance Report,
Medical Marketing and Media, and the FDA Advertising and Promotion Manual. Dr. Kamp is co
author (with Wayne Pines) of 3 books on compliance with FDA policy published by FDA News,
including DTC Advertising and Promotion: The Changing Environment, published in January
2006. He is also a public member of the National Advertising Review Board, the self regulation
body of the advertising industry run by the National Better Business Bureau.
Disclosure: John Kamp is Executive Director of the Coalition for Healthcare Communication, a
policy group with membership from trade associations including the American Association of
Advertising Agencies and the Association of Medical Media, and America s leading medical
marketing and education companies, Kamp has provided regulatory and strategic consulting
and/or regulatory training for several marketing companies, including Sudler & Hennessey, and
drug and device companies, including Cephalon and Wyeth. Kamp owns stock in companies in
the drug and device industries, including Johnson & Johnson, Pfizer, Amylin, Abbott, and
Sucampo and in related communication and media companies, including McGraw Hill,
Omnicom and WPP Group. Kamp also serves as of counsel at Wiley, Rein in Washington, DC.
Mr. Kamp is not an expert in the practice of medicine and does not make therapeutic
recommendations for any specific drug, device or procedure. Moreover, any discussion of "on
label" and "off label" use will be in the context of public policy; good industry practice;
and/or government rules, procedures and enforcement actions.
Healthcare Marketing in the Wake
MMA, FDAAA and Health Care Reform
Alliance REMS Conference
April 9, 2010
Agenda
Who We Are
Who We Are
Our Mission
Our Mission
Our Passions
Our Passions
What Legislation Matters to You
What Legislation Matters to You
What Needs to Happen
What Needs to Happen
Coalition for Healthcare Communication
Who Are We
AAAA Inventiv
AAFP IPG McCann-Draft FCB
Alliance Healthcare Information KnowledgePoint360
Ashfield Medical Massachusetts Medical Society
Association of Medical Media Omnicom
Elsevier Physician Education Resources
Euro RSCG Life Publicis Healthcare
Haymarket Slack
Healthline Networks US HealthConnect
WPP
The Coalition Mission
To promote and protect the benefit
of the free flow of healthcare information
for society and individual patients
Coalition Passions
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 marketing and
good business
Marketing is just as important as R & D
What s Changed that Matters To You
The Big Three Statutory Changes (for now)
1. MMA Medicare Part D adds drugs to Medicare
In effect, the first stage of health care reform for our industry
The government become the biggest payer of prescriptions
2. FDAAA empowers FDA to more aggressively manage drug risks
Including codification of Risk Evaluation and Mitigation Strategies
(REMS)
3. Health Care Reform
Including elevation of comparative effectiveness research,
accelerating the trend toward a national standards of medical care,
including prescribing decisions
Who Wins in Healthcare Reform
30 Million uninsured patients
Pharmaceutical Marketers/Educators
Industry pharma, bio and devices
Pharma Marketers
No sweeping change in the tax treatment of marketing
expenses
No direct limits on marketing messages or media
No DTC Ban
No new content mandates or bans (although FDA keeps
tightening)
No new disclosure mandates, particularly inclusion of comparative
effectiveness data
No ban on the marketing use of prescription data (although the
state versions continue)
But Transparency provision creates national registry of
payments to prescribers
Industry, especially pharma
PhRMA deal costs 80-90 Billion dollars starting in 2012, but
Retains US pricing, profit system for drugs and biologics
Adds 30+ million insured purchasers of medicines
Phases out donut hole in Medicare Part D
Reducing senior anxiety, anger at industry
Reducing incentive for patients to use generics
Establishes 12 year exclusivity for biologics
Creates new drug type approval regime for follow-on biologics
Avoids more aggressive price discounts (for now)
Avoids re-importation price pressures
Device industry pays more tax, but retains business model
FDAAA New Broad Safety Powers for FDA
Active surveillance system
REMS
Communication programs
Marketing channel controls
Restricted use
Follow up review, revisions, etc.
Labeling powers
New power to require studies, reports, and clinical
trials
Your REMS Questions
Do you think the FDA will put resources into public education
about REMS?
Do you believe REMS is designed more to win back public
confidence in the FDA rather than actual outcomes?
Do you think REMS will result in measurable improved public
safety?
Are there formal plans by the government to measure the
impact of REMS and report back?
What Must Happen
Value of Medical Communication Must Be Made Clear to
Policy Makers
Patient care, patient care, patient care
Must measure outcomes, circulate proof
Doctors and patients must join effort
Communication professionals must respect economic &
political realities & be prepared to adapt to rapid change
Must BE and be SEEN as part of the solution to the
delivery of effective, effective patient care
For Further Information
John Kamp
Coalition for Healthcare Communication
www:cohealthcom.org
*****@***********.***
Mary Ann Greenberg, Alliance Healthcare Information