Transcript Kamp"s slides - Coalition for Healthcare Communication

DC Politics/CHC Policy Update
January 9, 2013
John Kamp & Jack Angel
Coalition for Healthcare Communication
Who Are We
AAAA
Haymarket
Advanstar
InVentiv
AMM
IPG McCann
AAFP
KnowledgePoint360
Alliance Healthcare Information
Massachusetts Medical Society
Abelson Taylor
Omnicom
Beacon Healthcare
Pacific
CementBloc
Publicis Healthcare
Crossix
Q-forma
Connect Healthcare
Slack
Draft FCB
Thomas Direct
IMS
US HealthConnect
Elsevier
Vox Medica
Everyday Health
WPP
Havas/Euro RSCG Health
The Coalition Mission
To promote and protect, for society and individual
patients, the benefit of the free flow of healthcare
information
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
communication, marketing & education
•
Communication, marketing & education are just as
important as R & D, and provide significant value to
healthcare system
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
Election: Four More Years
• Obama Administration health leaders expected to stay at least
through 2013
• HHS Secretary Kathleen Sebelius moving full speed ahead on
Affordable Care Act Rules, Policies, Programs
– States given more time to create insurance exchanges
– Pent up rule announcements coming quickly
– Sunshine Act “final rules” still pending
• Expect many “phased in” rules, delays on many details,
industry education well before enforcement
– Senator Richard Blumenthal (D-Conn) speaking
aggressively on many pharma enforcement issues
FDA Leadership also stable
• Commissioner Margaret Hamburg tells insiders she will stay for
now
– Some staff shifts; David Dorsey gone
• Center for Drug Evaluation and Research senior staff stable
– Director Janet Woodcock and New Drugs Director John
Jenkins
• 2012 Drug approvals (39) best in a decade; the new era
of smaller, specialty drugs
– Rachel (Behrman) Sherman, Director of Medical Policy,
supervises OPDP. (Bob Temple now Deputy Director for
Clinical Science)
• Recognizes need to modernize label language, increase
consumer understanding of uses, dangers, etc.
– Tom Abrams remains head of OPDP
New Congress; same fiscal challenges
• Wonks, Wall Street, Washington still focused on debt, economy,
sequester deadline, taxes and cuts
• Tax and spending policy choices define the battles, but mostly a
question of how fast to reduce deficit
• No painless political choices available to either party
• Incredible pressure to avoid cuts in defense, Social
Security, Medicare
• Further tax increases would slow growth, kill tax
collections.
• Very dangerous time for any “tax expenditure,” including
deductibility of marketing
• The Advertising Coalition meeting with senior tax staff on House
Ways & Means and Senate Finance
Ad Tax Sword Still Hangs Above our Heads
• Jim Davidson, Chair of The Ad Tax Coalition
– “Now, more than any time in our history, the threat to the
deductibility of advertising costs is real. …Even in Washington
today, 37 billion dollars is a lot of money.”
• Dick O’Brien, Head of the DC office of the American Association
of Advertising Agencies
– “The (Fiscal Cliff) deal was just a Band-Aid…. The more
fundamental issue of how to bring the nation's debt under control
will still require serious tax code reform. Both parties agree on
that--and will probably tackle it squarely this year.”
• John Kamp
– “The danger cannot be ignored. No tax idea, good or bad, goes
away. Every expenditure needs matching federal income. Every
time a Senator or Member of Congress needs several extra billion
dollars, our industry will be at risk. “
Major Tax Legislation Possible in 2013
• Leaders focused on huge tax changes by end of 2013
• Ways & Means and Finance committees gearing up for Spring
hearings, preliminary votes starting as soon as April
• Considering limits on deductions beyond “the rich,” including
charitable contributions, home mortgage deduction, retirement
contributions
• Senate and House may be ahead of the White House
• But only a few Members of Congress are veterans of major tax
revisions, last done in 1986.
– No House Ways & Means vets of ’86 Act
– Only Grassley, Hatch and Baucus in Senate Finance
• Many lobbyists very skeptical of aggressive goals
• Ad Tax Coalition preparing for the worst
How Tax Legislation Matters
• Personal v. Corporate Income Tax
– Why did Willie Sutton rob banks? Personal tax is where the $$$ is!
• Old Game = looking for “pay fors” by tinkering with tax code,
mostly personal tax code with corporate flourishes
• New Game = reformation of the entire corporate tax code
• Same Game = when struggling over popular deductions, tax
rates, fairness, Medicare, Social Security, defense, look around
for another deduction to chop.
• The Advertising Tax Coalition includes you as a member of the
Coalition for Healthcare Communication, plus
– NAB, NCTA, NBC, CBS, NAA, MPA, 4As, ANA, etc.
Your Stake in Medical Marketing Tax Issue
• Currently, all marketing costs are tax deductible for clients, just
like rent, payroll & manufacturing
• Without deduction, client cost of marketing communication
increases by tax rate, as high as 37 %
• Likely client response:
– Immediately, cut 37% to make current budget
– Then, reassess all communication expense based on new ROI
where “I” increased by 37%
• Remember, PhRMA and many pharma clients were neutral on
this issue in debates on paying for Affordable Care Act
• Ad & media grassroots & lobbyists defeated the tax
• If YOU don’t engage, we cannot win this fight!
Privacy Legislation, Regulation
• Senator Jay Rockefeller, Chair of Senate Commerce Committee,
committed to moving legislation giving FTC greater power to
require consumers to “opt-in” before data collection, even for
non-personally identified information
– But two Senate Democrats supporting industry selfregulation re-elected, Kirsten Gillibrand (D-NY) & Claire
McCaskill (D-MO)
• House Commerce Committee controlled by Republicans
supporting industry self-regulation
• White House, Commerce Department & FTC -- all lead by
Obama appointees -- interested in “industry/consumer group
collaboration”
Coalition Comment to HHS on Sunshine
• HHS must enable industry to provide context and ensure
accuracy of payment reports to ensure that public, press and
policy-makers understand the purpose and public health value
of the physician collaborations
• HHS’ broad reading of Sunshine provisions is unnecessary and
counterproductive; public health demands more narrow and
careful implementation
• Indirect payments should not be reportable
• Ad supported publications should not be “gifts”
• Rules must be clear and definitive to ensure compliance,
consistency, efficiency and accuracy, and to avoid unnecessary
and expensive litigation and arbitrary enforcement
• Congressman Rob Andrews (D-NJ) writes HHS, supporting
Coalition & industry positions
U.S. v Caronia
• Federal 2nd Circuit Appeals Court reverses criminal conviction of
pharma rep for promoting a drug “off label”
• 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 most HHS IG/State “false claim” settlements
• FDA v. FTC enforcement: Is it on the label or is the audience
mislead. What will be the new standard of evidence?
• CHC taking a high profile, low key approach
• Colucci: IN GOD WE TRUST, ALL OTHERS BRING DATA
Issues for Action/Education
• Taxes
• Sunshine Act Final Rules & Implementation
• FDA OPDP enforcement & social media
• Privacy in Senate, FTC and Commerce
• Focus for CHC advocacy
– Comparative Effectiveness Data
– “Off-label” clarification/challenge to FDA
– Communication just as important R & D
For Further Information
• John Kamp, Executive Director
• Jack Angel, Coalition Foundation
Coalition for Healthcare Communication
www.cohealthcom.org
– 212-850-0708
– 202-719-7216
– [email protected]
SmartBrief for Healthcare Marketers – get it at web site
• Nick Colucci, Publicis, Chair of Executive Committee
• Matt Giegerich, Chair Elect