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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.
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Marketing in the Age of Obama
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, Special Interest Area Communities or affiliates, or any organization 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 the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
Disclaimer
2www.diahome.orgDIA
Mukesh Mehta, PDR Network
Christine Bradshaw, Porzio Life Sciences
Dale Cooke, Digitas Health
Our Presenters
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• Legislative Landscape• ARRA & EHRs• FDASIA & ACA Sunshine & ACOs
Agenda
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A busy few years
Three pillars of Obamacare• No one can be denied coverage• Individuals must purchase coverage• Subsidies make insurance affordable
And then the world changed
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1. Expanded pool of insured comprising:– Young, healthy people– People with preexisting conditions
2. Consistent coverage of basic care3. Individuals more responsible for
healthcare spending– “Cadillac” tax on health insurance– FSA changes
Marketing implications of Obamacare
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• Patient-Centered Outcomes Research Institute
• Non-profit institute established to conduct comparative effectiveness research
PCORI
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“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/
Sample PCORI Project: BioScreen for MS
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Sample PCORI Pilot Project
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Video available athttp://www.youtube.com/watch?v=BFAzIYwxadU#t=10
Sample PCORI Pilot Project
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FDASIA required FDA to issue social media guidance by August 1, 2014
FDASIA
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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf
But wait there’s more…
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The guidance addresses two questions about the 2253 submission:1. Whether to submit materials2. What to submit
What are postmarketing submissions?
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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”**
Determining whether to submit
* Postmarketing Guidance, page 3.** Postmarketing Guidance, page 4.
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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.
What to submit
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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
30-day submissions
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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?
Open questions
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