Analysis of Pharmaceutical Industry Criminal and Civil Penalties from 1991-2015

This data presentation highlights the number of settlements and financial penalties incurred by the pharmaceutical industry over the span of 25 years, from 1991 to 2015. The charts reveal trends in both the number of settlements and the financial implications, broken down by federal and state levels as well as multi-state versus single-state settlements. The data underscores the significant impact of regulatory penalties on the pharmaceutical sector during this period.

• Pharmaceutical industry
• Settlements
• Financial penalties
• Regulatory violations
• Data analysis

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1. Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015 (Chart Slide Set)* Sammy Almashat, M.D., M.P.H. Sidney M. Wolfe, M.D. Michael Carome, M.D. Public Citizen s Health Research Group March 31, 2016 Full report available at: www.citizen.org/hrg2311

2. 70 60 60 57 50 Number of Settlements 44 42 40 36 30 26 21 20 18 14 10 9 10 8 8 3 3 3 2 2 2 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

3. 7000 6348 6000 Financial Penalties ($ millions) 5000 44124339 3976 4000 3500 3000 2338 2208 2000 1441 1429 967 9991067 889 1000 549 642 489 100 22 10 10 7 4 3 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

4. 60 50 50 45 Number of Settlements 40 30 28 Federal State 26 24 20 18 18 16 13 12 11 10 10 10 10 8 8 8 7 7 6 5 4 3 3 2 2 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

5. 6000 5555 5000 Financial Penalties ($ millions) 4002 4000 3872 3812 3123 3000 Federal (F) State (S) 2071 2000 1712 1410 1122 1045 961 960 1000 889 793 625 549 527 377 410 404 356 307 287 137 104 85 58 42 39 32 22 22 10 8 6 5 4 3 2 2 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

6. 60 50 48 40 Number of Settlements 40 30 Multi-state Single-state 25 23 22 20 14 11 10 6 5 4 4 3 3 3 2 2 2 2 2 2 1 1 1 1 1 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

7. 450 417 397 400 376 365 347 350 335 Financial Penalties ($ millions) 300 250 228 Multi-state Single-state 200 192 186 147 150 140 121 100 88 85 71 66 63 50 42 36 28 13 16 12 10 6 4 3 3 2 2 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

8. 60 55 52 50 Number of Settlements 39 40 34 32 30 Civil Civil-Criminal Criminal 25 20 20 17 10 9 10 8 7 6 6 5 4 3 3 3 3 3 3 2 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

9. 5000 4482 4500 4000 3796 Financial Penalties ($ millions) 3500 3327 3000 2676 2466 2500 Civil (Cv) 2185 Criminal (Cr) 1946 2000 1866 1853 1500 1379 1012 1000 918 903 903 825 706 622 599549 538 489 485 500 293 290 149180 100 64 50 23 22 21 10 10 7 3 3 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

10. 3000 2645 2500 Financial Penalties ($ millions) 2000 1500 Defense Pharmaceutical 1203 1162 974 961 1000 888 717 640 599634 593 560 465 500 439 312 285 267 259 251 221 191 140 141169 161 149136 144 140 120 113 84 69 67 49 46 36 34 32 10 0 Fiscal Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

11. 18 16 16 14 Number of Settlements 12 10 10 8 8 qui tam non-qui tam 8 7 6 6 6 5 5 5 5 4 4 4 4 4 4 4 3 3 3 3 2 2 2 2 2 2 2 2 2 1 1 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

12. 6000 5410 5000 Financial Penalties ($ millions) 4000 3872 3853 3703 3119 3000 qui tam non-qui tam 2000 1449 1151 1102 978 746 1000 889 700775 500 664 622 562 404 328 262185 149109 144 67 58 49 28 22 10 8 21 5 4 1 4 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

13. 50 46 45 43 40 35 Number of Settlements 30 26 25 24 qui tam non-qui tam 20 20 17 15 13 10 7 6 5 4 4 4 2 2 2 2 2 1 1 1 1 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

14. 700 600 578 Financial Penalties ($ millions) 500 423 400 380 321 qui tam non-qui tam 300 287 285 279 242 215 203 200 137 95 100 85 56 42 39 32 30 28 10 13 9 6 3 2 2 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

15. Overcharging Government Health Programs (201) Unlawful Promotion (105) 101044 16 Kickbacks (47) 25 Monopoly Practices (25) Concealing Data (16) 47 Poor Manufacturing Practices (10) 201 Environmental Violations (10) Financial Violations (4) Illegal Distribution (4) 105 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

16. Unlawful Promotion ($11,090) Overcharging Government Health Programs ($5,059) Financial Violations ($3,562) 10887 11090 Monopoly Practices ($2,121) Poor Manufacturing Practices ($1,720) Kickbacks ($743) Concealing Data ($267) Environmental Violations ($232) 67 232 Illegal Distribution ($67) 267 1720 5059 Multiple Violations ($10,887)* 2121 743 3562 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

17. 1 4 2 Overcharging Government Health Programs (71) 5 7 Unlawful Promotion (43) Kickbacks (21) 21 Concealing Data (7) 71 Environmental Violations (5) Poor Manufacturing Practices (4) Monopoly Practices (2) Illegal Distribution (1) 43 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

18. Unlawful Promotion ($2,289) Monopoly Practices ($1,200) Overcharging Government Health Programs ($522) 2289 2714 Kickbacks ($460) Poor Manufacturing Practices ($392) Environmental Violations ($200) Illegal Distribution ($28) Concealing Data ($8) 8 1200 Multiple Violations ($2,714)* 28 200 392 460 522 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311

19. State Recoveries per $1,000 Medicaid prescription drug expenditures* Total Financial Penalties ($ millions)** Number of Settlements and Judgments ROI (dollars recovered per enforcement dollar spent)*** FCA as of 2015**** $148.20 $88.15 $48.59 $37.96 $37.40 $37.19 $34.18 $28.86 $27.38 $26.48 $20.85 $19.74 $16.84 $10.57 $9.97 $9.02 $8.35 $7.34 $6.27 $4.86 $4.54 $4.52 $3.71 $2.39 $1.80 $1.29 $1.26 $1.18 $0.22 $0.18 $9.50 [median] $83.75 $34.10 $169.00 $298.84 $584.10 $38.10 $163.90 $138.54 $124.25 $105.34 $15.00 $28.50 $44.50 $9.50 $46.25 $5.90 $50.13 $27.60 $163.30 $15.00 $37.00 $7.99 $5.70 $25.93 $4.30 $12.44 $14.00 $15.00 $1.30 $5.38 $2,274.64 2 2 2 55 19 16 8 20 9 13 1 3 2 1 6 1 8 2 3 1 3 5 2 2 2 2 2 2 1 4 199 $6.86 $1.60 $12.25 $5.49 $2.92 $5.86 $2.80 $5.52 $12.06 $3.98 $1.53 $1.64 $3.22 $0.56 $2.98 $0.84 $1.12 $2.16 $0.53 $0.51 $1.82 $0.48 $0.47 $0.50 $0.39 $0.21 $0.13 $0.07 $0.03 $0.01 $1.57 [median] Y Y Y Y Y Hawaii New Mexico South Carolina Louisiana Texas Idaho Pennsylvania Kentucky Alabama Mississippi Alaska Utah West Virginia Nevada Wisconsin Montana Massachusetts Connecticut California Maryland Missouri Oregon Kansas North Carolina Iowa Ohio Illinois Florida New Jersey New York Total / Median Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y 23/30

20. State Number of Settlements and Judgments Verifiable Financial Penalties ($ millions)* FCA** State Number of Settlements and Judgments Verifiable Financial Penalties ($ millions)* FCA** 28 28 28 27 27 27 27 26 26 25 25 25 25 24 24 $105.98Y $60.77Y $22.85 $46.99Y $34.19Y $19.37Y $16.73 $17.46Y $8.52Y $45.42Y $25.21Y $23.33Y $16.12Y $42.36Y $25.76 20 20 19 19 19 18 18 18 17 17 16 15 15 15 13 $27.41Y $12.47Y $11.27Y $1.89Y $0.00Y $3.33Y $0.00Y $0.00 $12.90Y $8.74 $9.19Y $3.02Y $0.00Y $0.00Y $12.58Y Texas Florida Arizona California North Carolina Massachusetts Vermont Wisconsin Maryland Illinois Washington Tennessee Nevada New York Ohio New Jersey South Dakota Delaware Nebraska Hawaii New Mexico Minnesota North Dakota Colorado Kentucky Rhode Island Montana Oklahoma South Carolina Indiana 24 24 23 23 23 22 22 22 21 21 21 $13.58Y $4.66Y $33.21Y $26.01 $11.72Y $19.65Y $14.31 $12.23Y $9.88Y $7.46Y $0.70Y 13 12 12 10 10 10 9 8 7 6 $0.00 $9.17Y $1.85Y $1.80Y $1.12 $0.10Y $2.86 $3.55Y $2.59Y $0.00Y District of Columbia Michigan Oregon Pennsylvania Connecticut Missouri Idaho Iowa Maine Arkansas Kansas Alabama Virginia West Virginia Louisiana Mississippi Utah Alaska New Hampshire Georgia Wyoming

21. State Number of Settlements and Judgments Verifiable Financial Penalties ($ millions)* FCA** State Number of Settlements and Judgments Verifiable Financial Penalties ($ millions)* FCA** 65 47 38 37 35 32 31 30 30 29 28 28 28 27 27 27 26 26 25 25 25 25 24 24 $300.64Y $690.08Y $52.41 $147.28 $69.50Y $63.71Y $189.91 $210.29Y $75.77Y $60.12Y $47.74Y $41.20Y $22.85 $59.42Y $23.52Y $16.73 $38.20 $25.62Y $56.65Y $39.32Y $25.21Y $23.33Y $16.53Y $13.58Y 23 22 21 21 21 21 20 20 19 19 18 18 17 17 16 16 15 14 13 13 12 10 8 7 $6.40Y $124.25 $83.75Y $28.71Y $9.88Y $7.46Y $37.43Y $12.47Y $11.27Y $1.89Y Louisiana Texas Idaho Kentucky Massachusetts Wisconsin Pennsylvania California Florida North Carolina New York Oregon Arizona Illinois Maryland Vermont Ohio Nevada Missouri Connecticut Washington Tennessee Iowa District of Columbia Kansas Alabama Hawaii New Jersey Maine Arkansas New Mexico South Dakota Delaware Nebraska Minnesota North Dakota South Carolina Colorado Rhode Island Montana Oklahoma West Virginia Utah Indiana Virginia Alaska New Hampshire Georgia $0Y $0 $169.00Y $12.90Y $9.19Y $8.92Y $0Y $46.35Y $28.60Y $12.58Y $9.17Y $17.86 $3.55Y $3Y 24 $4.66Y 6 $0Y Michigan Wyoming 23 $106.46 Mississippi

22. Company* Total Financial Penalties ($ millions) Percent of Total** Number of Settlements*** $7,881 22.0% 31 GlaxoSmithKline $3,943 11.0% 31 Pfizer $2,824 7.9% 19 Johnson & Johnson $1,841 5.1% 22 Merck $1,840 5.1% 16 Abbott $1,742 4.9% 15 Eli Lilly $1,471 4.1% 13 Teva $1,339 3.7% 6 Schering-Plough $1,250 3.5% 20 Novartis $1,024 2.9% 11 AstraZeneca $901 2.5% 12 Amgen $875 2.4% 1 TAP $795 2.2% 13 Bristol-Myers Squibb $715 2.0% 21 Mylan $704 2.0% 1 Serono $646 1.8% 5 Purdue $601 1.7% 2 Allergan $586 1.6% 8 Daiichi Sankyo $427 1.2% 15 Boehringer Ingelheim $425 1.2% 1 Cephalon $3,160 8.8% 170 Other**** Total $34,990 97.9% 433

23. Company** Number of Federal Settlements Total Federal Financial Penalties ($ millions) Percent of Total*** 11 $3,631 11.4% Pfizer 8 $7,393 23.1% GlaxoSmithKline 8 $1,125 3.5% Novartis 8 $747 2.3% Bristol-Myers Squibb 7 $1,662 5.2% Merck 6 $2,246 7.0% Johnson & Johnson 5 $1,308 4.1% Schering-Plough 5 $1,251 3.9% Teva 5 $932 2.9% AstraZeneca 4 $1,687 5.3% Abbott 3 $1,480 4.6% Eli Lilly 3 $802 2.5% Amgen 3 $547 1.7% Mylan 3 $539 1.7% Daiichi Sankyo 3 $308 1.0% Sanofi 3 $291 0.9% Bayer 3 $36 0.1% Novo Nordisk 2 $375 1.2% Boehringer Ingelheim 2 $232 0.7% Endo 2 $199 0.6% Par 24 (12 different companies) $493 1.5% Others**** Total 118 $27,284 85.4%

24. Company* Total Financial Penalties ($ millions) Percent of Total Number of Settlements** $2,234 28.6% 7 Johnson & Johnson $1,269 16.2% 7 Teva $976 12.5% 17 Pfizer $886 11.3% 6 Amgen $586 7.5% 6 Daiichi Sankyo $457 5.8% 8 Novartis $301 3.9% 8 GlaxoSmithKline $261 3.3% 5 Endo $134 1.7% 2 Actavis $95 1.2% 1 Boehringer Ingelheim $70 0.9% 4 AstraZeneca $63 0.8% 3 Shire $55 0.7% 4 Merck $51 0.7% 3 Par $40 0.5% 1 CareFusion $34 0.4% 1 Bausch+Lomb $31 0.4% 2 Eli Lilly $28 0.4% 1 DFB $26 0.3% 3 Purdue $25 0.3% 1 Glenmark Generics $190 2.4% 46 Other*** Total $7,813 100.0% 136

25. Company* Total Penalties, 2006-2015 ($ millions) Percent of Total Penalties, 2006-2015** Number of Settlements, 2006-2015*** Penalties, 2014-2015 ($ millions) Penalties in 2014- 2015 as a Proportion of Total Penalties from 2006-2015 $7,628 24.9% 26 $127 1.7% GlaxoSmithKline $3,458 11.3% 28 $240 6.9% Pfizer $2,822 9.2% 18 $22 0.8% Johnson & Johnson $1,837 6.0% 20 $37 2.0% Merck $1,822 5.9% 15 $10 0.5% Abbott $1,706 5.6% 14 Eli Lilly $1,471 4.8% 13 $1,235 84.0% Teva $1,230 4.0% 18 $390 31.7% Novartis $901 2.9% 12 $71 7.9% Amgen $669 2.2% 10 $54 8.1% AstraZeneca $646 2.1% 5 $24 3.7% Purdue $601 2.0% 2 Allergan $586 1.9% 6 $81 13.8% Daiichi Sankyo $583 1.9% 10 $15 2.5% Bristol-Myers Squibb $566 1.8% 20 Mylan $466 1.5% 2 Schering-Plough $425 1.4% 1 Cephalon $417 1.4% 14 Boehringer Ingelheim $355 1.2% 9 $125 35.2% Actavis $322 1.1% 12 Sanofi $1,880 6.1% 119 $419 22.3% Other**** Total $30,391 99.2% 374 $2,850 9.4%

26. Company** Number of Federal Settlements, 2006-2015 Total Federal Penalties, 2006-2015 ($ millions) Percent of Total Federal Penalties, 2006-2015*** Federal Penalties, 2014-2015 ($ millions)**** Federal Penalties in 2014-2015 as a Proportion of Total Federal Penalties from 2006-2015 9 $3,152 11.7% $195 6.2% Pfizer 6 $7,155 26.5% $0.5 0.0% GlaxoSmithKline 6 $2,246 8.3% Johnson & Johnson 6 $1,660 6.1% $37 2.2% Merck 6 $1,105 4.1% $390 35.3% Novartis 5 $1,251 4.6% $1,235 98.7% Teva 5 $535 2.0% $15 2.7% Bristol-Myers Squibb 4 $577 2.1% $54 9.4% AstraZeneca 3 $1,668 6.2% Abbott 3 $802 3.0% Amgen 3 $308 1.1% Sanofi 3 $36 0.1% Novo Nordisk 2 $1,444 5.3% Eli Lilly 2 $539 2.0% $39 7.2% Daiichi Sankyo 2 $398 1.5% Mylan 2 $375 1.4% Boehringer Ingelheim 2 $232 0.9% $232 100.0% Endo 2 $199 0.7% Par 2 $56 0.2% UCB 2 $45 0.2% KV 2 $36 0.1% 88.1% Biovail Total 77 $23,819 $2,197 9.2%

27. Company Total Penalty ($ millions) Year Violation(s)** Major Drug Products Involved (if applicable and known)*** Laws Violated (if known) Qui tam $3,400 2006 Financial violations Unlawful promotion; Kickbacks; Concealing data; Overcharging govt. health programs GlaxoSmithKline Paxil; Wellbutrin; Advair; Lamictal; Zofran; Imitrex; Lotronex; Flovent; Valtrex; Avandia $3,000 2012 FCA; FDCA Y GlaxoSmithKline $2,300 2009 Unlawful promotion ; Kickbacks Unlawful promotion; Kickbacks; Concealing data Unlawful promotion; Kickbacks; Concealing data**** Bextra; Geodon; Zyvox; Lyrica FCA; FDCA Y Pfizer Johnson & Johnson $2,006 2013 Risperdal; Invega; Natrecor FCA; FDCA FCA; FDCA; Anti- Kickback Statute Y $1,500 2012 Depakote Y Abbott $1,415 2009 Unlawful promotion Zyprexa FCA; FDCA Federal Trade Commission Act Y Eli Lilly $1,200 2015 Monopoly practices Teva $950 2011 Unlawful promotion Vioxx FCA; FDCA FCA; Anti-Kickback Statute; Prescription Drug Marketing Act Merck Overcharging govt. health programs; Kickbacks Unlawful promotion; Kickbacks; Overcharging govt. health programs $875 2001 Lupron Y TAP $762 2012 Aranesp; Enbrel; Neulasta Kytril; Bactroban; Paxil CR; Avandamet FCA; FDCA Y Amgen $750 2010 Poor manufacturing practices Unlawful promotion; Kickbacks; Monopoly practices Overcharging govt. health programs; Kickbacks FCA; FDCA Y GlaxoSmithKline $704 2005 Serostim FCA FCA; Medicaid Rebate Statute Y Serono $650 2008 Zocor; Vioxx; Pepcid Y Merck $600 2007 Unlawful promotion Oxycontin FCA Purdue $600 2010 Unlawful promotion Botox FCA; FDCA FCA; Anti-Kickback Statute Y Allergan $520 2010 Unlawful promotion; Kickbacks Kickbacks; Unlawful promotion; Overcharging govt. health programs Seroquel Y Y (Ven- a-Care) AstraZeneca Bristol-Myers Squibb $515 2007 Abilify; Serzone FCA; FDCA FDA Current Good Manufacturing Practices $500 2002 Poor manufacturing practices Schering Plough Cefaclor; Cefadroxil; Amoxicillin; Amoxicillin/Clavulanate; Sotret; Gabapentin; Ciprofloxacin Poor manufacturing practices; Concealing data Daiichi Sankyo***** $500 2013 FCA; FDCA Y $491 2013 Unlawful promotion Rapamune FCA; FDCA Y Pfizer

28. Company Total Penalty ($ millions) Federal/ State Year Violation(s)* Major Drug Products Involved (if applicable and known)** Laws Violated (if known) Qui tam Unlawful promotion; Kickbacks; Concealing data $2,006 Federal 2013 Risperdal; Invega; Natrecor FCA; FDCA Federal Trade Commission Act Y Johnson & Johnson $1,200 Federal 2015 Monopoly practices Unlawful promotion; Kickbacks; Overcharging govt. health programs Poor manufacturing practices; Concealing data Unlawful promotion Teva $762 Federal 2012 Aranesp; Enbrel; Neulasta Cefaclor; Cefadroxil; Amoxicillin; Sotret; Gabapentin; Ciprofloxacin Rapamune FCA; FDCA Y Amgen $500 $491 Federal Federal 2013 2013 FCA; FDCA FCA; FDCA FCA; Anti- Kickback Statute; federal civil forfeiture statute Y Y Daiichi Sankyo*** Pfizer Unlawful promotion; Kickbacks Environmental violations Unlawful promotion Unlawful promotion $390 $195 $193 $181 Federal Federal Federal State (mult) 2012 2015 2015 2014 Exjade; Myfortic Novartis Pfizer (Wyeth) Endo Johnson & Johnson Lidoderm Risperdal; Invega FCA; FDCA Y Unlawful promotion; Kickbacks Unlawful promotion Unlawful promotion; Kickbacks Unlawful promotion Unlawful promotion Actonel; Asacol; Atelvia; Doryx; Enablex; Estrace; Loestrin Advair; Paxil; Wellbutrin Aggrenox; Combivent; Micardis; Atrovent Avandia Aranesp; Enbrel Adderall XR; Vyvanse; Daytrana; Pentasa; Lialda Protonix FCA; Anti- Kickback Statute Actavis (Warner Chilcott) $125 GlaxoSmithKline Federal State (mult) 2014 2015 $105 $95 $90 $71 Federal State (mult) 2012 State (mult) 2015 2012 FCA Y Boehringer Ingelheim GlaxoSmithKline Amgen $57 $55 Federal Federal 2014 2012 Unlawful promotion Unlawful promotion Overcharging govt. health programs FCA FDCA Y Shire Pfizer (Wyeth) $47 Federal 2015 FCA Foreign Corrupt Practices Act FCA; FDCA Y AstraZeneca $45 $45 Federal Federal 2012 2013 Kickbacks Unlawful promotion Pfizer (Wyeth) Par Megace ES Avandia; Paxil; Wellbutrin; Advair; Lamictal; Zofran; Imitrex; Lotronex; Flovent; Valtrex Y $45 State (LA) 2013 Unlawful promotion GlaxoSmithKline

29. Type of Violation Description Inflating the average wholesale price (AWP) of products, failing to give the lowest market price to government health programs, or failing to pay required rebates to any government health program Overcharging Government Health Programs Off-label promotion of drug products or other deceptive marketing practices (e.g., downplaying health risks of a product) Unlawful Promotion Unlawfully attempting to keep monopoly patent pricing privileges on products, or collusion with other companies undertaken with the purpose of increasing the market share of a particular product Monopoly Practices Kickbacks (e.g., monetary payments) to providers, hospitals, or other parties to influence prescribing patterns in favor of the company Kickbacks Concealing results of company-sponsored studies, or other data, from the federal or state governments or the general public, or falsifying data submitted to the federal government Concealing Data* Selling drug products that fail to meet FDA standards or specifications (e.g., contaminated or adulterated products, or products that fail to meet size or dosage specifications) Poor Manufacturing Practices Clean Air Act and Clean Water Act violations, or failing to meet federal emissions standards Environmental Violations Accounting or tax fraud, or insider trading Financial Violations Distributing an unapproved pharmaceutical product Illegal Distribution