2009 Year In Review

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2009 Year in Review presentation from CBI Pharmaceutical Compliance Congress.

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  • 2 versions: 2 Rx Comp.
  • 2009 Year In Review

    1. 1. CBI Pharmaceutical Compliance Congress Year in Review January 25, 2010
    2. 2. 2009 YEAR IN REVIEW
    3. 3. Another Year of Settlements
    4. 4. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC Settlement Announced settlement Key:
    5. 5. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC $3.7 Million Alleged off-label promotion Settlement Announced settlement Key:
    6. 6. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC $95.5 Million Alleged violations of False Claims Act Settlement Announced settlement Key:
    7. 7. 2009 Federal Settlements July 2009 - $1.4M Alleged off-label promotion and Medicare fraud JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC Settlement Announced settlement Key:
    8. 8. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC August 2009 - $2.3B Alleged off-label promotion Settlement Announced settlement Key:
    9. 9. $24.6 Million Alleged conspiracy and kickback charges 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC Settlement Announced settlement Key:
    10. 10. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC $14 Million Alleged kickbacks with Omnicare (provider of pharmaceutical care for seniors) Settlement Announced settlement Key:
    11. 11. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC $118 Million Alleged price misrepresentation to Medicaid Settlement Announced settlement Key:
    12. 12. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC $2.6 Million Alleged false claims to Medicaid $520 Million Alleged off-label marketing of Seroquel Settlement Announced settlement Key:
    13. 13. 2009 Federal Settlements JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC $3.4 Million Alleged false claims to Medicaid Settlement Announced settlement Key:
    14. 14. JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC 2009 Federal Settlements $3.8 Million Alleged promotion of devices for an unintended use Settlement Announced settlement Key:
    15. 15. $22 Million Alleged kickbacks to doctors for heart devices JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC 2009 Federal Settlements Settlement Announced settlement Key:
    16. 17. State Settlements of Medicaid Pricing Allegations
    17. 18. January 2009 - $3.8M Mississippi
    18. 19. $3.8M Mississippi January 2009 - $7M Massachusetts
    19. 20. $3.8M Mississippi $7M Massachusetts February 2009 - $78.4M Alabama
    20. 21. $3.8M Mississippi $7M Massachusetts $78.4M Alabama March 2009 - $2.4M Kentucky
    21. 22. $3.8M Mississippi $7M Massachusetts $2.4M Kentucky $78.4M Alabama December 2009 - $8.5M Florida
    22. 23. $3.8M Mississippi $8.5M Florida $2.4M Kentucky $78.4M Alabama $7M Massachusetts December 2009 - $21.3M California
    23. 24. $3.8M Mississippi $7M Massachusetts $8.5M Florida $2.4M Kentucky $21.3M California $78.4M Alabama
    24. 25. State Updates Massachusetts enacts marketing code of conduct
    25. 26. State Updates Vermont updates disclosure law
    26. 27. State Updates New Jersey AG proposes physician gift ban and disclosure requirements
    27. 28. Individual Responsibility Former Sales Manager convicted of obstruction of justice Former Regional Manager pleads guilty to promotion of drugs for unapproved uses
    28. 29. Individual Responsibility Former CEO faces 20 years in prison and a $250,000 fine for wire fraud for issuing a press release that falsely portrayed clinical results
    29. 30. Individual Responsibility Four former executives indicted in connection with off-label promotion
    30. 31. Individual Responsibility Former sales representative pleads guilty to off-label promotion
    31. 32. Individual Responsibility Former executive charged with conspiracy to corrupt Greek HCPs – UK Serious Fraud Office
    32. 34. More than 30 Warning Letters Issued from DDMAC 9 DDMAC Warning Letters in April 2009 related to sponsored links on internet search engines
    33. 35. Meanwhile… Sen. Kohl and Sen. Durbin introduce amendment to ban data mining Both Houses pass Healthcare Reform Senate hears Medical Device Safety Act Sen. Grassley and Sen. Kohl amend Physician Payments Sunshine Act Senate seeks to increase $80B pledged for Healthcare Reform
    34. 37. 2009 Code, Practice, & Principle Revisions <ul><li>Good Reprint Practice </li></ul><ul><li>Draft Guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion </li></ul><ul><li>Institutional Review Boards FAQs </li></ul>
    35. 38. & Release New Guidelines Code on Interactions with HCPs Principles of DTC Advertising Principles on Clinical Trials Code of Ethics on Interactions with HCPs
    36. 39. Other Key Events Lilly, Merck, and GSK disclose spend OIG issues recommendations and findings regarding adverse event reporting of medical devices Institute of Medicine calls for doctors to stop taking gifts from drug makers Sen. Grassley reports 200 pharma qui tam suits Industry gives FDA’s social media hearing two thumbs up Wyeth v. Levine – Regulatory approval does not shield liability under state law
    37. 40. What did you work on in 2009?
    38. 41. Aggregate Spend Reporting <ul><li>State law reports </li></ul><ul><li>Sunshine Act preparation </li></ul><ul><li>Customer master </li></ul><ul><li>Data integrity and certification </li></ul><ul><li>Standard operating procedures </li></ul><ul><li>Change management and training </li></ul><ul><li>Third-party vendor data </li></ul><ul><li>Organization spend </li></ul><ul><li>Post-merger integration </li></ul><ul><li>Global payments </li></ul><ul><li>Spend monitoring </li></ul><ul><li>Business value </li></ul>
    39. 42. Web 2.0 Compliance
    40. 43. Auditing & Monitoring Risk assessment Investigations Speaker programs Pharmacovigilance Corrective & Preventive Actions Ride-alongs GxP Call notes T&E reporting
    41. 44. International Compliance <ul><li>FCPA </li></ul><ul><li>Country specific laws </li></ul><ul><li>Global transparency </li></ul><ul><li>EFPIA codes </li></ul><ul><li>PMCPA code of practice </li></ul>
    42. 45. Are you ready for
    43. 46. <ul><li>http://www.justice.gov/opa/pr/2009/November/09-civ-1253.html </li></ul><ul><li>http://www.justice.gov/opa/pr/2009/January/09-civ-038.html </li></ul><ul><li>http://www.justice.gov/usao/ma/Press%20Office%20- %20Press%20Release%20Files/Feb2009/NeurometrixPR.html </li></ul><ul><li>http://www.justice.gov/opa/pr/2009/May/09-civ-520.html </li></ul><ul><li>http://www.justice.gov/opa/pr/2009/July/09-civ-681.html </li></ul><ul><li>http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Sept2009/Pfizer.html </li></ul><ul><li>http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Sept2009/BiovailPlea.html </li></ul><ul><li>http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Nov2009/OmnicarePR.html </li></ul><ul><li>http://www.justice.gov/opa/pr/2009/October/09-civ-1120.html </li></ul><ul><li>http://online.wsj.com/article/SB10001424052748703363704574503022289816510.html?mod= googlenews_wsj </li></ul><ul><li>http://www.atricure.com/News_and_Events/AtriCure_Announces_Tentative_Settlement_with_the_Department_of_Justice_/ </li></ul><ul><li>http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Dec2009/GuidantPR.html </li></ul>Sources Federal Settlements <ul><li>New Jersey AG Proposes Physician Gift Ban and Disclosure Requirements, Dec 10 2009 </li></ul><ul><li>Pharma Faces Unprecedented Assault on industry-Prescriber Relations in 2009, Warns Industry Veteran: The Massachusetts Law, Jan 15 2009 </li></ul><ul><li>Vermont Legislature Passes Sweeping Gift Ban, May 21 2009 </li></ul><ul><li>Former Pfizer Manager Pleads Guilty to Off-Label Marketing, Apr 14 2009 </li></ul><ul><li>Former InterMune CEO Convicted of Wire Fraud in Connection with Off-Label Case, Sep 30 2009 </li></ul><ul><li>Three Guilty Pleas Under Responsible Corporate Officer Doctrine Signal Heightened Enforcement, Aug 6 2009 </li></ul><ul><li>DOJ Indicts Former Stryker CEO and Three Current Sales Managers, Oct 30 2009 </li></ul><ul><li>Industry Gives FDA’s Social Media Hearing Two Thumbs Up, Dec 10 2009 </li></ul>State Settlements <ul><li>http:// media.mylan.com/index.php?s =43&item=401 </li></ul><ul><li>http:// www.mass.gov/?pageID = cagopressrelease&L =1&L0= Home&sid = Cago&b = pressrelease&f =2009_01_05_teva_settle&csid= Cago </li></ul><ul><li>http:// www.law.com/jsp/tal/digestTAL.jsp?id =1202428551030 </li></ul><ul><li>http:// migration.kentucky.gov/Newsroom/ag/amgensettlement.htm </li></ul><ul><li>http://www.myfloridalegal.com/newsrel.nsf/newsreleases/C6F2638F1C4E40CF85257687005F3678 </li></ul><ul><li>http:// ag.ca.gov/newsalerts/print_release.php?id =1842 </li></ul><ul><li>http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=1&scp=1&sq=ghost%20writing%20rife&st= cse </li></ul><ul><li>http://www.nytimes.com/2009/11/16/business/16drugprices.html?scp=1&sq=drug%20makers%20raise%20prices%20in%20face%20of&st= cse </li></ul><ul><li>http://www.nytimes.com/2009/08/26/health/policy/26dual.html?scp=1&sq=waxman%20takes%20on%20drug%20makers%20over&st= cse </li></ul><ul><li>http://online.wsj.com/article/SB123879766861188121.html </li></ul><ul><li>http://online.wsj.com/article/SB123854648226076095.html </li></ul><ul><li>http://online.wsj.com/article/SB123854648226076095.html </li></ul><ul><li>http://blogs.wsj.com/law/2009/08/06/big-pharmas-latest-tab-415-million-to-settle-vytorin-zetia-suits/ </li></ul><ul><li>http://blogs.wsj.com/health/2009/02/26/another-drug-company-accused-of-hiding-negative-study-results/ </li></ul><ul><li>http://online.wsj.com/article/SB125685873503217267.html </li></ul>
    44. 47. <ul><li>http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773 </li></ul>Sources Internet Ads and DDMAC <ul><li>http://www.policymed.com/2009/12/health-care-reform-kohl-durban-amendment-bans-data-mining.html </li></ul><ul><li>http://www.cnn.com/2009/POLITICS/12/24/health.care/index.html </li></ul><ul><li>http://content.nejm.org/cgi/content/full/360/15/1550 </li></ul><ul><li>http://www.opencongress.org/bill/111-s301/show </li></ul><ul><li>http://www.boston.com/news/health/articles/2009/09/29/60_doctors_took_speaker_fees_from_drug_giant/ </li></ul>Other News 2009 Code, Practice, & Principle Revisions <ul><li>http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf </li></ul><ul><li>http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf </li></ul><ul><li>http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM171256.pdf </li></ul><ul><li>http://www.phrma.org/files/attachments/PhRMA%20Marketing%20Code%202008.pdf </li></ul><ul><li>http://www.phrma.org/files/attachments/042009_Clinical%20Trial%20Principles_FINAL.pdf </li></ul><ul><li>http://www.phrma.org/files/attachments/PhRMA%20Guiding%20Principles_Dec%2008_FINAL.pdf </li></ul><ul><li>http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf </li></ul><ul><li>http://www.policymed.com/2009/08/physician-payment-sunshine-eli </li></ul><ul><li>lilly-post-payments-to-health-care-professionals.html </li></ul><ul><li>http://www.policymed.com/2009/10/physician-payment-sunshine merck </li></ul><ul><li>second-pharmaceutical-company-to-disclose-payments-to-physicians.html </li></ul><ul><li>http:// www.policymed.com /physician-payment-disclosure/ </li></ul><ul><li>http://oig.hhs.gov/oei/reports/oei-01-08-00110.pdf </li></ul><ul><li>http://www.nytimes.com/2009/04/29/health/policy/29drug.html </li></ul><ul><li>http://grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=23563 </li></ul><ul><li>http://www.policymed.com/2009/03/supreme-court-decision-on-wyeth-vs-levine-opens-legal-flood-gates.html </li></ul>Other Key Events Individual Responsibility <ul><li>http://www.sfo.gov.uk/our-work/latest/former-vice-president-of-depuy-international-ltd-charged-with-corruption.aspx </li></ul>Animation, Music and Pictures: PhRMA and AdvaMed Code
    45. 48. Content And Graphics By: www.potomac river partners.com

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