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非法推銷 致人上癮 強力類鴉片止疼藥商Insys提出2.25億和解金


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Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Wednesday, June 5, 2019

Opioid Manufacturer Insys Therapeutics Agrees to Enter $225 Million Global Resolution of Criminal and Civil Investigations

Company Admits Illegal Conduct Regarding Promotion of Subsys, a Powerful Opioid Painkiller

Opioid manufacturer Insys Therapeutics agreed to a global resolution to settle the government’s separate criminal and civil investigations, the Department of Justice announced today. As part of the criminal resolution, Insys will enter into a deferred prosecution agreement with the government, Insys’s operating subsidiary will plead guilty to five counts of mail fraud, and the company will pay a $2 million fine and $28 million in forfeiture. As part of the civil resolution, Insys agreed to pay $195 million to settle allegations that it violated the False Claims Act. Both the criminal and civil investigations stemmed from Insys’s payment of kickbacks and other unlawful marketing practices in connection with the marketing of Subsys. Insys’s drug Subsys is a sublingual fentanyl spray, a powerful, but highly addictive, opioid painkiller. In 2012, Subsys was approved by the Food and Drug Administration for the treatment of persistent breakthrough pain in adult cancer patients who are already receiving, and tolerant to, around-the-clock opioid therapy. 

Today, the U.S. Attorney’s Office for the District of Massachusetts filed an Information charging Insys and its operating subsidiary with five counts of mail fraud. According to the charging document, from August 2012 to June 2015, Insys began using “speaker programs” purportedly to increase brand awareness of Subsys through peer-to-peer educational lunches and dinners. However, the programs were actually used as a vehicle to pay bribes and kickbacks to targeted practitioners in exchange for increased Subsys prescriptions to patients and for increased dosage of those prescriptions. One practitioner targeted by Insys was a physician’s assistant who practiced with a pain clinic in Somersworth, New Hampshire. During the first year that Subsys was on the market, the physician’s assistant did not write any Subsys prescriptions for his patients. In May 2013, the physician’s assistant joined Insys’s sham speaker program knowing that it was a way to receive kickbacks for writing Subsys prescriptions. After joining the sham speaker program, the physician’s assistant wrote approximately 672 Subsys prescriptions for his patients – many of which were medically unnecessary – and in turn, received $44,000 in kickbacks from Insys.




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As part of the criminal resolution, Insys agreed to a detailed statement of facts outlining its criminal conduct with respect to the illegal marketing of Subsys. Insys will enter into a five-year deferred prosecution agreement with the government, while Insys’s operating subsidiary will plead guilty to five counts of mail fraud pursuant to the plea agreement that will be filed in the District of Massachusetts. According to the terms of the criminal resolution, Insys will pay a criminal fine of $2 million and forfeiture of $28 million. The Court has not yet scheduled the plea hearing. Last month, five former Insys executives were convicted after trial of racketeering conspiracy in connection with the marketing of Subsys. In total, eight company executives have now been convicted in Boston for crimes relating to the illegal marketing of Subsys.

In April 2018, the United States intervened in five qui tam lawsuits accusing Insys of violating the civil False Claims Act. In its Complaint, the United States alleged that Insys, headquartered in Arizona, paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients. In addition to payments for sham speaker program speeches, the kickbacks also allegedly took the form of jobs for the prescribers’ relatives and friends,  and lavish meals and entertainment. The United States also alleged that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.



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“The Department of Justice is committed to taking steps to address the opioid epidemic,” said Principal Deputy Associate Attorney General Claire Murray. “Illegal conduct by pharmaceutical manufacturers, especially in the midst of the opioid crisis, will not be tolerated. We will continue to investigate and vigorously prosecute these types of allegations and hold opioid manufacturers accountable under the law.”

“The opioid epidemic has devastated communities and ravaged families across this country,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice is committed to using the legal tools at our disposal to combat the illegal marketing and distribution of opioids, including fentanyl. Today’s settlement sends a strong message to pharmaceutical manufacturers that the kinds of illegal conduct that we have alleged in this case will not be tolerated. I want to assure the families and communities ravaged by this epidemic that the Department of Justice will hold opioid manufacturers accountable for their actions.”

“This criminal resolution today with Insys, coupled with the convictions of the eight executives, shows this Office’s resolve to hold both corporations and individuals accountable for their crimes,” said United States Attorney for the District of Massachusetts Andrew E. Lelling.“For years, Insys engaged in prolonged, illegal conduct that prioritized its profits over the health of the thousands of patients who relied on it. Today, the company is being held responsible for that and for its role in fueling the opioid epidemic. This global resolution is the culmination of years of work by prosecutors and agents, and these successful prosecutions and civil enforcement efforts should be a model for confronting corporate criminal activity.”




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“Today’s settlement underscores our determination to hold opioid manufacturers accountable for pushing these highly addictive narcotics on the public via kickbacks to doctors and nurses, and other illegal means,” said United States Attorney for the Central District of California Nick Hanna. “Our goal is to bring about an end to the tragic epidemic of opioid addiction and to go after those who profit from that epidemic.”

“Paying bribes and providing other incentives to prescribe opioids with little regard to patient welfare surely signals a company is more concerned with profits than patients,” said Christian J. Schrank, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services. “Today’s settlement reaffirms our commitment to ensuring that companies pay a very heavy price for attacking vital government health programs.”

Insys entered into an unprecedented 5-year Corporate Integrity Agreement (CIA) and Conditional Exclusion Release with OIG. Because of the extensive cooperation provided by Insys in the prosecution of culpable individuals and its agreement to enhanced CIA requirements, OIG elected not to pursue exclusion of Insys at this time. The CIA includes several novel provisions, including enhanced material breach provisions, designed to protect Federal health care programs and beneficiaries. In addition, Insys admitted to a Statement of Facts and acknowledged that the facts provide a basis for permissive exclusion. OIG did not release its permissive exclusion authority, as it generally does for CIA parties in False Claims Act settlements. Instead, OIG will provide such a release only after Insys satisfies its obligations under the CIA.



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“The announced settlement is a vivid example of the Department of Defense's dogged efforts to protect the integrity of the U.S. military’s health care system and its beneficiaries” said Bryan D. Denny, Special Agent in Charge of the Defense Criminal Investigative Service, Western Field Office. “DCIS remains committed to working with its law enforcement partners and the U.S. Attorney’s Office to combat health care fraud, especially when pharmaceutical companies use taxpayers' dollars to induce physicians with bribes and kickbacks to prescribe their drugs for unauthorized off-label usage that may very well endanger the recipient's health and safety.”

“I applaud the Department of Justice and the U.S. Attorney for their continued efforts to hold pharmaceutical companies accountable to the American taxpayer,” said Vice Adm. Raquel Bono, director of the Defense Health Agency. “The efforts of the Department of Justice safeguard the health care benefit for our service members, veterans and their families. The Defense Health Agency continues to work closely with the Justice Department, and other state and federal agencies to investigate all those who participated in fraudulent practices.”

The allegations resolved by the settlement stem from five lawsuits that were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private citizens to bring suit on behalf of the United States for false claims and share in any recovery. The lawsuits are: United States, et al., ex rel. Guzman v. Insys Therapeutics, Inc., et al., 13-cv-5861; United States ex rel. Andersson v. Insys Therapeutics, Inc., 14-cv-9179;United States ex rel. John Doe and ABC, LLC v. Insys Therapeutics, Inc., et al., 14-cv-3488; United States ex rel. Erickson and Lueken v. Insys Therapeutics, Inc., 16-cv-2956; and United States ex rel. Jane Doe, et al. v. Insys Therapeutics, et al., 16-cv-7937. The whistleblowers’ share of the settlement announced today has not yet been determined.         



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These matters were handled by the Department of Justice’s Civil Division, the United States Attorney’s Office for the District of Massachusetts, the United States Attorney’s Office for the Central District of California, and the Department of Health and Human Services, Office of Inspector General. Investigations were conducted by the FBI, Boston Field Division; the Food and Drug Administration, Office of Regulatory Affairs; the Drug Enforcement Administration, New England Field Division; Department of Defense, Defense Criminal Investigative Service; U.S. Department of Labor, Employee Benefits Security Administration, Boston Regional Office; U.S. Postal Inspection Service’s Boston Division; United States Postal Service, Office of Inspector General, Northeast Area Field Office; Department of Veterans Affairs, Office of Inspector General, Criminal Investigations Division; Office of Personnel Management, Office of Inspector General; and the Defense Health Agency. 






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6/07/2019

非法推銷 強力止疼藥Insys提出2.25億和解金


(World Journal) 編譯孫梁


圖為該公司創辦人凱普爾(John Kapoor)今年初離開波士頓法院。(美聯社)

類鴉片藥物生產商Insys Therapeutics公司因非法推銷極易使人上癮的強力止疼藥,遭到聯邦的刑事與民事調查;檢方表示,Insys公司同意以2億2500萬元達成和解。

作為和解協議的一部分,公司將被處以刑事罰款200萬元、被沒收資產2800萬元,以及為違反聯邦的虛假宣傳法律而支付1億9500萬元和解費。

和解協議是Insys公司與司法部、衛生部督察長和部分聯邦檢察官辦公室達成的;該公司表示,協議符合公司和股東的最大利益。

檢方指出,Insys公司在2012年8月到2015年6月推出宣傳計畫,向醫護人員提供賄賂和回扣,以使他們開具處方藥Subsys。Subsys是一種基於芬太尼的藥物,噴在舌下含服。


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檢方說,新罕布夏州一名醫生助理2013年5月加入Insys的宣傳計畫後,開出Sybsys處方藥672個,得到4萬4000元回扣。

麻州的聯邦檢察官表示,Insys公司多年來從事非法推銷,他們更重視公司利益,而不是數千名消費者的健康,今天Insys公司要為此和為鴉片類藥物的氾濫而付出代價。

芬太尼是合成類鴉片藥,2011至2016年致死的人數暴增1000%。

波士頓的聯邦陪審團上月認為,Insys公司五名主管的敲詐預謀罪成立,指控公司八名主管非法營銷Subsys的罪成。

司法部指出,類鴉片藥物的氾濫危害了全國各地的社區和家庭,今天達成的和解協議是向藥廠發出強有力的訊息,類似Insys公司的推銷活動不能忍受,司法部將追究生產商的責任。






John Kapoor

From Wikipedia, the free encyclopedia

John Nath Kapoor (born 1942/1943) is a former billionaire pharmaceutical entrepreneur and now convicted felon. He is the founder of Insys Therapeutics.[2] In 2017, Kapoor was arrested and charged with RICO conspiracy, conspiracy to commit wire fraud, and other crimes. He was convicted on all counts in 2019.[citation needed] He also owns a large stake in the generic drugmaker Akorn.[2][3]

Early life[edit]

John Nath Kapoor[4] was born in Amritsar, India, into a family of modest means. He later moved to Mumbai, where he graduated from the Institute of Chemical Technology (formerly UDCT) with a degree in pharmacy.[5][6] He went toUniversity at Buffalo on a scholarship and obtained a doctorate in medicinal chemistry in 1972.[6]

Career[edit]

He began his career in 1972 at Invenex Pharmaceutical on Grand Island, NY.

He worked his way up at LyphoMed, took the company public and oversaw its operations through a scandal involving lax production standards that resulted in several patients' deaths.[2][7]

Personal life[edit]

He moved from India to Lake Forest, Illinois. He has four children and now lives in Phoenix, Arizona. The John and Editha Kapoor Charitable Foundation, which supports the fight against cancer, was named after his late wife Editha, who died of breast cancer.[1] The University at Buffalo School of Pharmacy and Pharmaceutical Sciences named their building John and Editha Kapoor Hall, after a donation to the school by John, to honor him and his late wife. On June 3, 2019, the University of Buffalo passed a resolution to remove Kapoor's name from the UB Pharmacy School's building in light of Kapoor's RICO conviction.[8]

Legal issues[edit]

In October 2017, Kapoor was arrested in Arizona and charged with RICO conspiracy, conspiracy to commit wirefraud, and conspiracy to violate the Anti-Kickback Law.[9] The charges stem from allegations that he participated in a scheme to bribe doctors to prescribe fentanyl, a powerful synthetic opioid manufactured under the brand name Subsys by his company Insys Therapeutics.[10] U.S. Attorney William Weinreb said the charges reflected authorities' commitment to combat theopioid epidemic.[10] Kapoor is also alleged to have conspired to defraud health insurance providers.[9] Shortly after the charges were announced, Kapoor resigned from the Board of Insys Therapeutics.[11]

On May 2, 2019 Kapoor was convicted of engaging in a racketeering conspiracy to increase the profits of his company's opiate painkiller, Subsys.[12]





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