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2009 Year In Review

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2009 Year in Review presentation from CBI Pharmaceutical Compliance Congress.

2009 Year in Review presentation from CBI Pharmaceutical Compliance Congress.

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