美国制药行业的刑事和民事处罚（1991-2017）

beiwei5du · 发表于 2018-4-22 18:54:24

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Twenty-Seven Yearsof Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017

March 14, 2018

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Public Citizenpublished a report that catalogues all major financial settlements and courtjudgments between pharmaceutical companies and federal and state governmentsfrom 1991 through 2017. The report found that drugmakers entered into 412settlements totaling $38.6 billion in criminal and civil penalties, but thatthe number and size of federal and state settlements against the pharmaceuticalindustry remained low in 2016 and 2017, with federal criminal penalties nearlydisappearing.

Executive Summary

Background

Public Citizen haspublished three previous reports — in 2010, 2012, and 2016 — documenting thenumber and size of criminal and civil settlements and court judgments reachedbetween the federal and state governments and pharmaceutical manufacturers. The2016 report, which included all settlements from 1991 through 2015, revealedthat the pace of settlement activity had decreased considerably in thethen-most-recent two-year period. The current report analyzes settlementsannounced in 2016 and 2017, thereby providing collective data for the 27 yearsfrom 1991 through 2017.

Methods

Methodology wasidentical to that employed for the 2016 report. Note that the current reportand the 2016 report included all settlements, regardless of the magnitude ofthe financial penalty. However, for the time period prior to July 19, 2012,only settlements of $1 million or greater were included. We changed ourmethodology beginning with the 2016 report to include settlements of less than$1 million primarily to ensure that totals for smaller states (which are morelikely to have smaller settlements) were not underrepresented.

Main Findings

From 1991 through2017, a total of 412 settlements were reached between the federal and stategovernments and pharmaceutical manufacturers, for a total of $38.6 billion. For2016 and 2017, 38 settlements for a total of $2.9 billion occurred. Thesetotals are comparable to the number of settlements (39) and overall financialpenalties ($2.9 billion) in the previous two-year period (2014-2015). Totalsettlements in each of these two-year intervals were significantly lower thanthe 117 settlements totaling $9.8 billion in 2012-2013. Other key findingsinclude the following:

· In 2016 and 2017, 29 federal settlementsfor a total of $2.8 billion occurred. These totals are somewhat higher than theprevious two-year (2014-2015) totals of 19 settlements for $2.4 billion.However, both financial-penalty totals were significantly lower than the $8.7billion total for the 22 federal settlements in 2012-2013. The averagefinancial penalty in 2016-2017 ($97 million per federal settlement) and in2014-2015 ($128 million per federal settlement) were both markedly lower thanthe $394 million per federal settlement in 2012-2013. Thus, the average penaltyper settlement in 2016-2017 decreased by 75% from the average penalty in2012-2013.

· The continued low levels of financialpenalties in 2016-2017 were primarily due to a continued decrease in financialpenalties (almost all federal) from settlements involving unlawful promotion ofprescription drugs. Such penalties have declined drastically, by 94%, sincetheir peak in 2012-2013 – from $8.7 billion then to just $527 million in2016-2017. This is the lowest two-year total since 2003-2004.

· Another striking finding was a dramaticdecrease in criminal penalties (which have all been federal since 1991). In2012-2013, criminal penalties totaled $2.7 billion, but by 2016-2017, the totalhad fallen to $317 million, an 88% decrease.

· In 2016 and 2017, there were just 9 statesettlements for a total of $82 million, the lowest two-year total for both thenumber of settlements and the amount of financial penalties since 2004-2005.

· From 1991 through 2017, overcharging ofgovernment health programs (mainly drug pricing fraud against state Medicaidprograms) was the most common violation, but the number of settlementsinvolving this violation has decreased dramatically in recent years, with justthree federal or state settlements involving overcharging of government healthprograms in 2016-2017 and eight settlements in 2014-2015, compared with 78 suchsettlements in 2012-2013.

· Qui tam (whistleblower) revelations,brought mostly under the False Claims Act, were responsible, at least in part,for 92 of 170 (54%) federal settlements, and $24.7 billion of $34.8 billion(71%) in federal penalties, from 1991 through 2017. By contrast, from 1991through 2017, a much lower proportion of state settlements (17 of 242; 7%) andstate financial penalties ($791 million of $3.9 billion; 20%) originated fromqui tam actions.

· From 1991 through 2017, 31 states reachedat least one single-state settlement with a pharmaceutical company. Hawaiirecovered the most money as a proportion (15%) of Medicaid drug expenditures,Alabama recouped the most money per enforcement dollar spent ($10.02), andLouisiana had the most single-state settlements (55). During these 27 years, 16of the 31 states with at least one single-state settlement have attained areturn on investment of $1 or greater per enforcement dollar spent, meaningthey recouped enough money through financial penalties from thesepharmaceutical settlements alone to offset their entire (pharmaceutical andnon-pharmaceutical) Medicaid fraud enforcement budgets from FY 2006 to FY 2017.

· From 1991 through 2017, GlaxoSmithKline andPfizer paid more in financial penalties — $7.9 billion and $4.7 billion,respectively — and reached more settlements (32 and 34, respectively) with thefederal and state governments than any other companies. Johnson & Johnson,Teva, Merck, Abbott, Eli Lilly, Schering-Plough, Novartis, Mylan, andAstraZeneca were the other companies that paid more than $1 billion infinancial penalties from 1991 through 2017, with Teva and Mylan having joinedthe $1 billion list over the past two years. Thirty-seven companies haveentered into multiple settlements with the federal government from 1991 through2017, with Pfizer (14), GlaxoSmithKline (9), Novartis (9), Bristol-Myers Squibb(8), Teva (7), and Merck (7) finalizing the most federal settlements.

Conclusion

The number and sizeof federal and state settlements against the pharmaceutical industry remainedlow in 2016 and 2017, with federal criminal penalties nearly disappearing.Financial penalties continued to pale in comparison to company profits, withthe $38.6 billion in penalties from 1991 through 2017 amounting to only 5% ofthe $711 billion in net profits made by the 11 largest global drug companiesduring just 10 of those 27 years (2003-2012).

To our knowledge, aparent company has never been excluded from participation in Medicare andMedicaid for illegal activities, which endanger the public health and depletetaxpayer-funded programs. Criminal prosecutions of executives leading companiesengaged in these illegal activities have been extremely rare. Much largerpenalties and successful prosecutions of company executives that overseesystemic fraud, including jail sentences if appropriate, are necessary to deterfuture unlawful behavior. Otherwise, these illegal but profitable activitieswill continue to be part of companies’ business model.