Download pdf - DIA 2014 Marketing Pharmaceuticals Conf Marketing in Age of Obama

Marketing in the Age of Obama

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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


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


• Patient-Centered Outcomes Research Institute

• Non-profit institute established to conduct comparative effectiveness research

PCORI


“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


Sample PCORI Pilot Project


Video available athttp://www.youtube.com/watch?v=BFAzIYwxadU#t=10

Sample PCORI Pilot Project


FDASIA required FDA to issue social media guidance by August 1, 2014

FDASIA


http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf

But wait there’s more…


The guidance addresses two questions about the 2253 submission:1. Whether to submit materials2. What to submit

What are postmarketing submissions?


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.


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


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


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
