DC Update
CHC Member Meeting
October 21, 2015
John Kamp
Coalition for Healthcare Communication
So, Who Are We
AAAA
Juice Pharma
Advanstar
Massachusetts Medical Society
Association of Medical Media
Omnicom/DAS
AAFP
Pacific Communications
Abelson Taylor
Publicis Healthcare
Beacon Healthcare
Radius Medical Animation
Crossix
ReachMD/US Health Connect
Everyday Health
Reed Elsevier
Frontline/Quadrant
Slack
Havas Health
Springer
Haymarket
Wolters Kluwer
HMP Communications
WebMD
IPG
WPP/Ogilvy
The Coalition Mission
To promote and protect, for society and individual
patients, the benefit of the free flow of healthcare
information
Significant Accomplishments
• Supreme Court victory in IMS v. Sorrell protects aggressive,
innovative Rx marketing, expands industry 1st Amendment
rights, prompts US v. Caronia decision, recent appeals by
Amarin and Pacira
• 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, including provision in 21st Century
Cures Act
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
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
Prelude to Presidential Election
• Are we in the election phase or still in an entertainment
phase?
• Trump & Sanders vs. Bush & Clinton
• Still months away from nominating conventions and any virtual
decision on nominees
• Bear in mind
– Drug pricing, even DTC advertising, part of campaign slogans
– A Democratic sweep of both Houses and White House could
change the pricing flexibility of pharma
– A Republican sweep would be taken as a mandate to again reform
healthcare, destabilizing increasing patient counts
– Shake up could alter course of Congressional tax reform
Major Marketing Issues Brewing in 2015
• Tax reform and deductibility of marketing costs
• Path to 21st Century Cures, awaiting Senate action
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HR 293 Exempting Textbooks, Reprints & CME from Sunshine
FDAMA 114 Communication with Payers
Off Label communications
One Click Away/Twitter
• HHS/CMS policies on Sunshine
• FDA marketing regulation & court challenges
• Anti-pharma political rhetoric
• PDUFA VI bill must pass in 2017
Health Committees in Senate & House
• House Energy and Commerce Committee
– Fred Upton (R-Mich), Chair and co-sponsor with Diana DeGette
(D- CO) of 21st Century Cures Legislation
• Focus on medical innovation, new drugs, FDA approval process, etc.
• Three communication provisions included in final House bill
– Ranking Minority Frank Pallone (D-NJ)
– Health Subcommittee: Chairman Joe Pitts (R-PA)
• Senate HELP Committee
– Chairman Lamar Alexander (R-TN)
• Preparing companion bill to House 21st Century Cures
– Ranking Member Patty Murray (D-WA)
• Senate Finance Committee
– Chairman Orrin Hatch (R-UT)
• Jurisdiction on the Burgess (CME and reprints) Amendment
– Ranking Member Ron Wyden (D-OR)
Path to 21st Century Cures legislation
includes three communication provisions
Offered by Chairman Fred Upton (R-TX) and Congresswoman
Diana DeGette (D-CO). Wide spread provisions to spur medical
innovation. Senate counterpart pending.
Passed by House, 344-77 (Amazing bi-partisan agreement)
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 (DOR) introduced HR-293, to exempt peer-reviewed journals,
journal reprints, journal supplements, and medical textbooks as
well as all CME related activity
– 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 payers and similar
entities – extends and expands FDAMA 114
– More data and more entities
• 3. Sets deadline for FDA to develop new guidance on “off-label”
marketing
• 4. DELETED: 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
– Introduced as a stand-alone bill by Congressman Billy Long (RMO)
– “Long shot” at best for this Congressional session
Meanwhile, changes at HHS, FDA
• Obama’s HHS will finish strong on ACA
– Aggressive administrative action countered by contentious
congressional oversight
• Sylvia Mathews Burwell at top of HHS
– Focus on management, lower political/Hill profile
– Will press hard to finish Obama Care
– Few dramatic changes in policies on Sunshine or FDA
• Acting Commissioner Dr. Stephen Ostroff
– Robert Califf nominated by White House
• Senate nomination hearing before Thanksgiving (?)
– Stability at Center for Drugs
• Janet Woodcock, Director
• John Jenkins, head of New Drugs
• Tom Abrams, head of OPDP
• Drug approvals continue to be robust, especially for breakthrough
and orphan drugs
New CMS rule favors Sunshine CME Exclusion
• July 3, 2014 CMS proposed to eliminate the Sunshine Act
exemption from reporting for CME speakers and attendees
• October 31, 2014 CMS deleted exemption but reinterpreted the
rule to take most industry sponsored CME activities totally out
of the rule
• Inconsistent Q & A guidance confuses industry; inconsistent
legal guidance at companies
• CME payments now not reportable so long as industry sponsor
“does not require, instruct, direct, or otherwise cause” the
payments to go to specific recipient doctors
• 21st Century Cures amendment would settle uncertainty
FDA OPDP (DDMAC) New Guidance
• Evolving policy spurred by 1st Amendment challenges, FDA will
be very slow to evolve, expect minor changes
– FDA reviewing policies and promising new guidance on off-label,
social media, scientific exchange, health care economics and
unsolicited requests
• Amarin v. United States: Off-label Federal District Court
decision limits FDA enforcement in that case
• 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
1st Amendment court challenges force FDA
to reconsider off-label communication bans
• 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 1st Amendment
• Ruling: Truthful, non-misleading communication between rep
and physician is speech protected by the 1st Amendment and
cannot be used to jail rep for “misbranding” a drug
• Undermines all FDA off-label enforcement and many HHS
IG/State “false claim” settlements
• Amarin challenged FDA and won this summer, Pacira filed
similar appeal
• PhRMA leading pressure for FDA change, calling for off label
reform starting with open discussions with payers.
• CHC supporting PhRMA and MIWG at FDA and in court appeals
Recent website and Smart Brief articles
• Follow John Kamp on Twitter and subscribe to
SmartBrief for Health Care Marketers
– “CHC and CCC Launching Regulatory Compliance University for
Agencies, Publishers”
– “Senate Bill Would Loop Nurse Practitioners and PAs into Sunshine
Reporting”
– “Which Standard of Truth Will Be Used to Evaluate Nonmisleading Ad Claims?”
– “Prescription Drug Marketing Targeted by Hillary Clinton”
– “Pacira Files Complaint Calling FDA Marketing Restrictions
Unconstitutional”
– “Kamp on Presidential Politics: They Matter to Medical Marketers”
– “Amarin Federal Court Decision: FDA Off-label Marketing Rules
Violate First Amendment”
– “FDA Will Study How Market Claims, Efficacy Info Affect
Consumers in DTC Print Ads”
For further information
• John Kamp, Executive Director
• Jack Angel, Coalition Foundation
Coalition for Healthcare Communication
– (NYC) 212-850-0708
– (DC) 202-719-7216
– (m) 703-801-4582
– jkamp@aaaa.org
– Twitter: RxVoice
• Matt Giegerich, WPP, Chair of the Executive Committee
• Sharon Callahan, Omnicom, Secretary & Chair Elect
• Board members throughout the room