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, 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. DIAwww.diahome.org2 3. Our PresentersMukesh Mehta, PDR Network Christine Bradshaw, Porzio Life Sciences Dale Cooke, Digitas HealthDIAwww.diahome.org3 4. Agenda Legislative Landscape ARRA & EHRs FDASIA & ACA Sunshine & ACOsDIAwww.diahome.org4 5. A busy few yearsDIAwww.diahome.org5 6. And then the world changedThree pillars of Obamacare No one can be denied coverage Individuals must purchase coverage Subsidies make insurance affordableDIAwww.diahome.org6 7. Marketing implications of Obamacare1. Expanded pool of insured comprising: Young, healthy people People with preexisting conditions2. Consistent coverage of basic care 3. Individuals more responsible for healthcare spending Cadillac tax on health insurance FSA changes DIAwww.diahome.org7 8. PCORI Patient-Centered Outcomes Research Institute Non-profit institute established to conduct comparative effectiveness researchDIAwww.diahome.org8 9. Sample PCORI Project: BioScreen for MSBioScreen 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/DIAwww.diahome.org9 10. Sample PCORI Pilot ProjectDIAwww.diahome.org10 11. Sample PCORI Pilot ProjectVideo available at http://www.youtube.com/watch?v=BFAzIYwx adU#t=10DIAwww.diahome.org11 12. FDASIAFDASIA required FDA to issue social media guidance by August 1, 2014http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf DIAwww.diahome.org12 13. But wait theres moreDIAwww.diahome.org13 14. What are postmarketing submissions?The guidance addresses two questions about the 2253 submission: 1. Whether to submit materials 2. What to submitDIAwww.diahome.org14 15. Determining whether to submitThree 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. DIAwww.diahome.org15 16. What to submit1. 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.DIAwww.diahome.org16 17. 30-day submissionsPublicly 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 themselvesNot 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 discussionDIAwww.diahome.org17 18. Open questions1. 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?DIAwww.diahome.org18