This is my portion of the session I led at the DIA 2014 Marketing Pharmaceuticals Conference about the impact of some of the recent legislative changes on people responsible for marketing pharmaceuticals in the United States.

1. Marketing in the
Age of Obama

2. Disclaimer
The views and opinions expressed in the following PowerPoint
slides are those of the individual presenter and should not be
attributed to Drug Information Association, Inc. (“DIA”), its directors,
officers, employees, volunteers, members, chapters, councils,
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with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the
individual presenter and are protected under the copyright laws of
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permission. All rights reserved. Drug Information Association, DIA
and DIA logo are registered trademarks or trademarks of Drug
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their respective owners.
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3. Our Presenters
Mukesh Mehta, PDR Network
Christine Bradshaw, Porzio Life Sciences
Dale Cooke, Digitas Health
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4. Agenda
• Legislative Landscape
• ARRA & EHRs
• FDASIA & ACA Sunshine & ACOs
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5. A busy few years
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6. And then the world changed
Three pillars of Obamacare
• No one can be denied coverage
• Individuals must purchase coverage
• Subsidies make insurance affordable
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7. Marketing implications of Obamacare
1. Expanded pool of insured comprising:
– Young, healthy people
– People with preexisting conditions
2. Consistent coverage of basic care
3. Individuals more responsible for
healthcare spending
– “Cadillac” tax on health insurance
– FSA changes
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8. PCORI
• Patient-Centered Outcomes Research
Institute
• Non-profit institute established to conduct
comparative effectiveness research
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9. Sample PCORI Project: BioScreen for MS
“BioScreen was originally designed for researchers and physicians. But with
the Patient-Centered Outcomes Research Institute (PCORI) Pilot Project
funding, the UCSF team is converting the tool into an accessible source of
information for patients to use with guidance from their clinicians. Input from
community members with expertise in emerging technologies and legal and
administrative issues has helped the researchers create a secure digital portal
to a library of up-to-date, anonymous clinical information. BioScreen is intended
to improve care by fostering patients’ interactions with clinicians, self-reporting
of clinical information, and compliance to treatment plans.”
—From PCORI website,
http://www.pcori.org/funding-opportunities/pfa-awards/pilot-projects/pilot-program-featured-page-hauser-2/
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10. Sample PCORI Pilot Project
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11. Sample PCORI Pilot Project
Video available at
http://www.youtube.com/watch?v=BFAzIYwx
adU#t=10
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12. FDASIA
FDASIA required FDA to issue social media
guidance by August 1, 2014
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf
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13. But wait there’s more…
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14. What are postmarketing submissions?
The guidance addresses two questions
about the 2253 submission:
1. Whether to submit materials
2. What to submit
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15. Determining whether to submit
Three sets of circumstances:
1. Sites “owned, controlled, created, influenced, or
operated by, or on behalf of the firm…. even if
the influence is limited.”*
2. Site pages if the firm “influenced the placement”
of promotional materials.**
3. When agents or employees are “acting on
behalf of the firm”**
* Postmarketing Guidance, page 3.
** Postmarketing Guidance, page 4.
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16. What to submit
1. For static materials with interactive components, submit static and
indicate what changes (e.g., which portion of the website houses
an online discussion forum)
2. For third-party sites, submit static elements with first
communication (e.g., first Tweet & Twitter profile page).
3. Submit a monthly listing of locations (URLs) with real-time
discussion.
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17. 30-day submissions
Publicly accessible discussions
> Submit a list of URLs where real-time discussions are happening
> Update the list every 30 days (confirming, adding, or removing as
necessary) to reflect current involvement
> Do NOT submit the actual interactions themselves
Not publicly accessible discussions (e.g., behind a log-in)
> Submit a list of URLs where real-time discussions are happening
> Update the list every 30 days (confirming, adding, or removing as
necessary) to reflect current involvement
> Submit screenshots or other representations of the actual interactions
themselves
> Indicate what discussion sponsor owns
> Provide enough context for FDA to understand/evaluate the discussion
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18. Open questions
1. What constitutes being publicly accessible?
a) If you have to “like” a page to view it, is it publicly accessible?
2. Does this open up or limit the activities of employees?
a) Do companies now have to submit the URL of every employee
who mentions a product on their Twitter, Facebook, Tumblr,
Pinterest, etc.?
3. Are companies responsible for sites where they
advertise?
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