“Novartis and its team of greedy doctors betrayed that trust by duping patients into taking medication as part of a fraudulent kickback scheme and cheated the state out of millions while putting the health and safety of countless individuals at risk.
The agreement resolves allegations that from January 2002 to November 2011, Novartis paid kickbacks to doctors to prescribe Lotrel, Valturna, Starlix, Tekamlo, Diovan HCT, Tekturna HCT, and Exforge HCT, and that between January 2010 and November 2011, Novartis also did so for Exforge, Diovan, and Tekturna.
Corporate conductAllegationAgainst
Novartis is accused of prescription drug price fixing
New Jersey Office of Attorney General alleges Novartis engaged in prescription drug price fixing with Sandoz.
Acting AG Davenport Files Multistate Complaint Against Novartis and Sandoz Alleging Prescription Drug Price Fixing - New Jersey Office of Attorney General
Corporate conductSettlementAgainst
Novartis settles fraud claims over doctor inducements
Novartis settled a civil fraud lawsuit alleging it provided doctors with cash, meals, and alcohol to induce prescriptions of its cardiovascular and diabetes drugs reimbursed by federal healthcare programs.
Acting Manhattan U.S. Attorney Announces $678 Million Settlement Of Fraud Lawsuit Against Novartis Pharmaceuticals For Operating Sham Speaker Programs Through Which It Paid Over $100 Million To Doctors To Unlawfully Induce Them To Prescribe Novartis Drugs
Under the settlement, NOVARTIS will pay a total of $678,000,000, of which (i) $591,442,008.92 will be paid to the United States as False Claims Act damages, (ii) $38,406,717.42 will be forfeited to the United States as proceeds of violations of the Anti-Kickback Statute; and (iii) $48,151,273.66 will be paid to various States.
NOVARTIS’s compliance training materials suggested that emails advocating illegal kickbacks were improper in part because they “reflect[] ignorance of the import of written communications, and put[] the Company at risk.” NOVARTIS’s Chief Compliance Officer also stated in training presentations: “If you don't have to write it, don’t.
Lampert said: “The various kickback schemes employed by Novartis threatened the impartiality of medical decision-making and the financial integrity of Medicare and Medicaid.
For example, Novartis admitted that in Long Island, at least one sales representative organized fraudulent speaker programs by arranging for a restaurant to create fake receipts to make it appear that a dinner had taken place, and then used the budgeted funds to purchase gift cards that were distributed to high-prescribing doctors.
In its court filings, the New York Attorney General’s Office (NYAG) alleged that Novartis paid doctors to speak about certain drugs at sham events, which were falsely advertised as educational, in an attempt to evade the law.
Novartis-315 Page 2 of 19 On April 26, 2013, the United States intervened in the Civil Action against Novartis by filing a Notice of Election to Intervene and Complaint -in-Intervention, in which it is assert ed that claims against Novartis under the FCA and common law.
The company admitted giving doctors cash, golf and fishing trips, and lavish meals at some of the nation’s fanciest restaurants to induce them to prescribe Novartis cardiovascular and diabetes drugs that were reimbursed by federal healthcare programs, the government said in a release.
The settlement resolves a 2011 whistleblower lawsuit accusing Novartis of violating the federal False Claims Act and Anti-Kickback Statute. The company admitted giving doctors cash, golf and fishing trips, and lavish meals at some of the nation’s fanciest restaurants to induce them to prescribe Novartis cardiovascular and diabetes drugs that were reimbursed by federal healthcare programs, the government said in a release.
Federal authorities alleged that Novartis earned hundreds of millions of dollars in federal reimbursements for selling drugs sold by doctors benefiting from tens of thousands of sham educational events at high-end restaurants and other venues.
Novartis AG (NYSE: NVS) has reached a $678 million settlement in a civil fraud lawsuit that alleged the company bribed doctors at speaker events it organized.
Department of Defense - Office of Inspector General’s Defense Criminal Investigative Service (“DCIS”), and Christopher Algieri, Special Agent in Charge the Department of Veterans Affairs, Office of Inspector General, Northeast Field Office (“VA OIG”), announced today that the United States has settled a civil fraud lawsuit against NOVARTIS PHARMACEUTICALS CORPORATION (“NOVARTIS”), part of Swiss drug manufacturer Novartis International AG, alleging that NOVARTIS violated the federal False Claims Act and Anti-Kickback Statute by providing doctors with cash payments, recreational outings, lavish meals, and expensive alcohol to induce them to prescribe NOVARTIS cardiovascular and diabetes drugs reimbursed by federal healthcare programs.
Consider using the phone.” Under the settlement, NOVARTIS will pay a total of $678,000,000, of which (i) $591,442,008.92 will be paid to the United States as False Claims Act damages, (ii) $38,406,717.42 will be forfeited to the United States as proceeds of violations of the Anti-Kickback Statute; and (iii) $48,151,273.66 will be paid to various States. The settlement also requires NOVARTIS to reform its business practices.
FOR IMMEDIATE RELEASE Wednesday, July 1, 2020 U.S. Attorneys » Southern District of New York » News » Press Releases Department of Justice U.S. Attorney’s Office Southern District of New York Acting Manhattan U.S. Attorney Announces $678 Million Settlement Of Fraud Lawsuit Against Novartis Pharmaceuticals Corporation For Operating Sham Speaker Programs Through Which It Paid Over $100 Million To Doctors To Unlawfully Induce Them To Prescribe No Novartis Admits to Certain Conduct Alleged in the Lawsuit and Agrees to Strict Limitations on Its Ability to Conduct Future Speaker Programs Audrey Strauss, the Acting United States Attorney for the Southern District of New York, William F.
Under the CIA, Novartis must significantly reduce the number of programs and the number of paid physicians, and can no longer pay for inherently-risky in-person programs.” HHS-OIG Special Agent in Charge Scott J.
Acting Manhattan U.S. Attorney Announces $678 Million Settlement Of Fraud Lawsuit Against Novartis Pharmaceuticals Corporation For Operating Sham Speaker Programs Through Which It Paid Over $100 Million To Doctors To Unlawfully Induce Them To Prescribe No | Oversight.gov
Lampert said: “The various kickback schemes employed by Novartis threatened the impartiality of medical decision-making and the financial integrity of Medicare and Medicaid.
Under the settlement, NOVARTIS will pay a total of $678,000,000, of which (i) $591,442,008.92 will be paid to the United States as False Claims Act damages, (ii) $38,406,717.42 will be forfeited to the United States as proceeds of violations of the Anti-Kickback Statute; and (iii) $48,151,273.66 will be paid to various States.
NOVARTIS’s compliance training materials suggested that emails advocating illegal kickbacks were improper in part because they “reflect[] ignorance of the import of written communications, and put[] the Company at risk.” NOVARTIS’s Chief Compliance Officer also stated in training presentations: “If you don't have to write it, don’t.
Department of Defense - Office of Inspector General’s Defense Criminal Investigative Service (“DCIS”), and Christopher Algieri, Special Agent in Charge the Department of Veterans Affairs, Office of Inspector General, Northeast Field Office (“VA OIG”), announced July 1, 2020, that the United States has settled a civil fraud lawsuit against NOVARTIS PHARMACEUTICALS CORPORATION (“NOVARTIS”), part of Swiss drug manufacturer Novartis International AG, alleging that NOVARTIS violated the federal False Claims Act and Anti-Kickback Statute by providing doctors with cash payments, recreational outings, lavish meals, and expensive alcohol to induce them to prescribe NOVARTIS cardiovascular and diabetes drugs reimbursed by federal healthcare programs.
Lampert, Special Agent in Charge of HHS-OIG’s New York Regional Office, Leigh-Alistair Barzey, Special Agent in Charge of the Northeast Field Office of the U.S. Department of Defense - Office of Inspector General’s Defense Criminal Investigative Service (“DCIS”), and Christopher Algieri, Special Agent in Charge the Department of Veterans Affairs, Office of Inspector General, Northeast Field Office (“VA OIG”), announced July 1, 2020, that the United States has settled a civil fraud lawsuit against NOVARTIS PHARMACEUTICALS CORPORATION (“NOVARTIS”), part of Swiss drug manufacturer Novartis International AG, alleging that NOVARTIS violated the federal False Claims Act and Anti-Kickback Statute by providing doctors with cash payments, recreational outings, lavish meals, and expensive alcohol to induce them to prescribe NOVARTIS cardiovascular and diabetes drugs reimbursed by federal healthcare programs.
Acting Manhattan U.S. Attorney Announces $678 Million Settlement Of Fraud Lawsuit Against Novartis Pharmaceuticals Corporation For Operating Sham Speaker Programs Through Which It Paid Over $100 Million To Doctors To Unlawfully Induce Them To Prescribe No | Department of Veterans Affairs OIG
Corporate conductSettlementAgainst
Novartis settles for $390 million over kickbacks
Novartis agreed to a $390 million settlement after being accused of giving kickbacks to specialty pharmacies for recommending Exjade and Myfortic.
Southern District of New York | Manhattan U.S. Attorney Announces $370 Million Civil Fraud Settlement Against Novartis Pharmaceuticals For Kickback Scheme Involving High-Priced Prescription Drugs, Along With $20 Million Forfeiture Of Proceeds From The Scheme | United States Department of Justice
District Judge Colleen McMahon approved a settlement to resolve the Government’s claims against NOVARTIS.
Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Office of the Federal Bureau of Investigation (“FBI”), Gregory E. Demske, Chief Counsel to the Inspector General of the U.S. Department of Health and Human Services (“HHS-OIG”), and Scott J. Lampert, Special Agent in Charge of HHS-OIG’s New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. (“NOVARTIS”) in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.
Lampert, Special Agent in Charge of HHS-OIG’s New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. (“NOVARTIS”) in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.
Lampert said: “Novartis’s kickbacks and other aggressive sales tactics, as alleged in this case, threatened the impartiality of medical decision-making and the financial integrity of Medicare and Medicaid.
Pharmaceutical company Novartis Pharmaceuticals Corporation (Novartis), based in East Hanover, New Jersey, has agreed to pay over $642 million in separate settlements resolving claims that it violated the False Claims Act (FCA).
Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Office of the Federal Bureau of Investigation ("FBI"), Gregory E. Demske, Chief Counsel to the Inspector General of the U.S. Department of Health and Human Services ("HHS-OIG"), and Scott J. Lampert, Special Agent in Charge of HHS-OIG's New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. ("NOVARTIS") in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.
Manhattan U.S. Attorney Announces $370 Million Civil Fraud Settlement Against Novartis Pharmaceuticals For Kickback Scheme Involving High-Priced Prescription Drugs, Along With $20 Million Forfeiture Of Proceeds From The Scheme | Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services
Lampert, Special Agent in Charge of HHS-OIG's New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. ("NOVARTIS") in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.
Pharmaceutical company Novartis Pharmaceuticals Corporation (Novartis), based in East Hanover, New Jersey, has agreed to pay over $642 million in separate settlements resolving claims that it violated the False Claims Act (FCA).
The State contends that it has certain civil and administrative causes of action against Novartis for engaging in the following conduct (the “Covered Conduct”): The State contends that Novartis paid kickbacks and violated the federal Anti-Kickback Statutes as follows: (a) from in or about February 2007 to in or about May 2012, Novartis (i) gave patient referrals, discounts and rebates to Accredo Health Group, Inc. (“Accredo”), BioScrip, Inc. (“BioScrip”), and U.S.Page 2 of 14
The State contends that it has certain civil and administrative causes of action against Novartis for engaging in the following conduct (the "Covered Conduct"): The State contends that Novartis paid kickbacks and violated the federal Anti Kickback Statute as follows: (a) from in or about February 2007 to in or about May 2012, Novartis (i) gave patient referrals, discounts and rebates to Accredo.
8/96 Page·3 ofl4 Bioservices Corporation (“US Bioservices”) to induce these pharmacies to recommend to patients that they order Exjade refills and (ii) thereby caused Accredo, BioScrip and US Bioservices to submit false claims to Medicaid for reimbursement for Exjade that were not eligible for payment; and (b) from in or about June 2004 to in or about December 2013, Novartis (i) gave discounts and/or rebates to specialty pharmacies (including Transcript Pharmacy, Bryant’s Pharmacy and Healthcare Center, Kilgore’s Medical Pharmacy, Baylor Health Care System, and Twenty-Ten Pharmacy) in return for their agreement to recommend to physicians to prescribe Myfortic instead of the competitor drug CellCept and (ii) thereby caused these pharmacies to submit false claims to Medicaid for reimbursement for Myfortic that were not eligible for payment. F.
Lampert, Special Agent in Charge of HHS-OIG’s New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. (“NOVARTIS”) in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.
Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Office of the Federal Bureau of Investigation (“FBI”), Gregory E. Demske, Chief Counsel to the Inspector General of the U.S. Department of Health and Human Services (“HHS-OIG”), and Scott J. Lampert, Special Agent in Charge of HHS-OIG’s New York Regional Office, announced a $390 million settlement against NOVARTIS Pharmaceuticals Corp. (“NOVARTIS”) in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.
Manhattan U.S. Attorney Announces $370 Million Civil Fraud Settlement Against Novartis Pharmaceuticals for Kickback Scheme Involving High-Priced Prescription Drugs, Along with $20 Million Forfeiture of Proceeds from the Scheme — FBI
District Judge Colleen McMahon approved a settlement to resolve the Government’s claims against NOVARTIS.
Under that settlement, NOVARTIS agrees to (i) pay $370,000,000 to resolve the federal and state false claims act claims, (ii) forfeit $20 million as proceeds from the scheme under the federal civil forfeiture statute, (iii) make extensive admissions concerning its relationship with specialty pharmacies, and (iv) amend its corporate integrity agreement with HHS-OIG to subject NOVARTIS’s specialty pharmacy relationships to independent review and extend the term of that agreement by five years.
13 release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a -7b(f)) against Novartis under 42 U.S.C. § 1320a -7a (Civil Monetary Penalties Law) or 42 U.S.C. § 1320a -7(b)(7) (permissive exclusion for fraud, kickbacks, and other prohibited activities) for the Covered Conduct, except as reserved in Paragraph 11 (concerning excluded claims), below, and as reserved in this Paragraph.
those drugs to be submitted to and paid by Medicare, Medicaid, the Department of Veterans Affairs and TRICARE, in violation of the FCA; and (ii) from January 1, 2010, through November 21, 2011, Novartis paid remuneration in the form of cash, meals, alcohol, hotels, travel, entertainment, and honoraria payments to HCPs who spoke at or attended Novartis speaker events, roundtables, speaker training meetings or lunch-n-learns to induce them to prescribe Diovan, Tekturna, and Exforge in violation of the AKS, and thereby caused false claims for prescriptions for Diovan, Tekturna, and Exforge to be submitted to and paid by Medicare, Medicaid, the Department of Veterans Affairs and TRICARE, in violation of the FCA.
Corporate conductConfirmedAgainst
Novartis transfers drugs at government-dictated prices
Novartis transferred its products to third parties at government-dictated prices far below market values after ENTRESTO® was included in the Program.
After its innovative drug ENTRESTO® was selected for inclusion in the Program, Novartis was forced to perform sham “negotiations” over a purported “maximum fair price” for its drug, execute a series of “agreements” misrepresenting that process to the public, and then transfer its products to third parties at government-dictated prices far below market values.
Corporate conductSettlementAgainst
Novartis AG agreed to pay $25 million to settle FCPA violations related to pay-to-prescribe schemes in China
The Securities and Exchange Commission today announced that Novartis AG has agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) when its China-based subsidiaries engaged in pay-to-prescribe schemes to increase sales.
Novartis AG - The Swiss-based pharmaceutical company agreed to pay $25 million to settle charges that it violated the FCPA when its China-based subsidiaries engaged in pay-to-prescribe schemes to increase sales.
The Securities and Exchange Commission today announced that Novartis AG has agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) when its China-based subsidiaries engaged in pay-to-prescribe schemes to increase sales.
Novartis consented to the order without admitting or denying the findings, and agreed to pay $21.5 million in disgorgement of profits plus $1.5 million in prejudgment interest and a $2 million penalty.
Taking its allegations as true, Novartis and Vetter sought to deceive the PTO and the market at large by concealing Vetter’s inventorship.
Corporate conductSettlementAgainst
Novartis AG agreed to pay $112 million to settle FCPA violations
The Securities and Exchange Commission today announced that Novartis AG, a global pharmaceutical and healthcare company headquartered in Basel, Switzerland, has agreed to pay over $112 million to settle charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA).
The order also finds that Novartis lacked sufficient internal accounting controls within its former Alcon business in China from 2013 to 2015, which used forged contracts as part of local financing arrangements that generated large losses and resulted in Novartis and Alcon writing off more than $50 million in bad debt.
Novartis consented to the entry of an order requiring the company to cease and desist from committing violations of the books and records and internal accounting controls provisions of the FCPA.
The Securities and Exchange Commission today announced that Novartis AG, a global pharmaceutical and healthcare company headquartered in Basel, Switzerland, has agreed to pay over $112 million to settle charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA).
The SEC's order finds that local subsidiaries or affiliates of Novartis or its former subsidiary Alcon Inc. engaged in schemes to make improper payments or to provide benefits to public and private healthcare providers in South Korea, Vietnam, and Greece in exchange for prescribing or using Novartis or Alcon products.
engaged in schemes to make improper payments or to provide benefits to public and private healthcare providers in South Korea, Vietnam, and Greece in exchange for prescribing or using Novartis or Alcon products.
Corporate conductConfirmedAgainst
Novartis took into account HCP prescription sales for sponsorships
Novartis Korea employees considered HCP prescription sales activities when targeting them for sponsorships to incentivize higher prescriptions.
In connection with some congresses, Novartis Korea employees took into account the prescription sales activities of certain HCPs when targeting them for sponsorships in an effort to encourage the HCPs to increase their prescriptions.
Workplace equityConfirmedAgainst
Novartis ends diverse panels due to U.S. policy changes
Novartis told Reuters it will end its use of diverse panels because of evolving U.S. laws and policies.
Novartis told Reuters on Wednesday that evolving laws and policies in the U.S. would require it to change, and listed the end of its use of diverse panels as one immediate change to its own policies.
Novartis told Reuters on Wednesday that evolving laws and policies in the U.S. would require it to change, and listed the end of its use of diverse panels as one immediate change to its own policies.
Workplace equityAllegationAgainst
Novartis is accused of salary discrimination
Novartis faces a lawsuit alleging its former sales rep's salary was $20,000 less than a male colleague pitching the same drug.
Pharmaceutical giant Novartis must face a former sales representative's lawsuit alleging her salary was over $20,000 less than a male colleague pitching the same drug, a Colorado federal judge ruled, saying...
ManufacturingConfirmedYou decide
Novartis opens cancer drug facility in Carlsbad
Novartis opened a new 10,000-square-foot manufacturing facility in Carlsbad to produce cancer drugs as part of a $23 billion U.S. investment plan.
Swiss drugmaker Novartis opened a new 10,000-square-foot manufacturing facility in Carlsbad to make cancer drugs, as part of its promised $23 billion investment push to build out its domestic U.S. facilities over the next five years.
This content was published on Apr 30, 2026 Novartis is expanding its production capacity in the United States, with the announcement of a new site in Morrisville, North Carolina. This plant will bring to seven the number of new sites planned as part of its $23 billion investment plan.
ManufacturingConfirmedYou decide
Novartis opens seventh U.S. plant
Novartis opens seventh plant in the United States, Keystone-SDA.
Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization | FDA
Corporate conductRecallAgainst
Novartis recalls 100 mg Sandimmune and Neoral blister packs
Novartis recalled 100 mg Sandimmune and Neoral blister packages due to failure to meet child-resistant packaging requirements, posing a poisoning risk.
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Johnson & Johnson and Novartis Brussels, 21 October 2011 - The European Commission has opened an antitrust investigation, on its own initiative, to assess whether contractual arrangements between US-based pharmaceutical company Johnson & Johnson and the generic branches of the Swiss-based company Novartis may have had the object or effect of hindering the entry on to the market of generic versions of Fentanyl in The Netherlands.
On 18/10/2011, the European Commission decided to initiate formal antitrust proceedings against the US-based Johnson & Johnson and the Swiss-based Novartis AG, and their respective subsidiaries in the Netherlands, Janssen-Cilag B.V.
Corporate conductConfirmedAgainst
Novartis development eliminates future competition with GSK
Novartis development of BRAF and MEK inhibitors is alleged to eliminate substantial future competition with GSK in inhibitor development and sales.
§ 45, by: Eliminating substantial future competition between GSK and Novartis in a. the development and sale of BRAF-inhibitors; and Eliminating substantial future competition between GSK and Novartis in b. the development and sale of MEK-inhibitors.
§ 45, by: Eliminating substantial future competition between GSK and Novartis in a. the development and sale of BRAF-inhibitors; and Eliminating substantial future competition between GSK and Novartis in b. the development and sale of MEK-inhibitors.
Corporate conductRulingAgainst
The U.S. Nuclear Regulatory Commission (NRC) issued a notice of violation (NOV) to Novartis Manufacturing
On July 31, 2026, the U.S. Nuclear Regulatory Commission (NRC) issued a notice of violation (NOV) to Novartis Manufacturing, LLC, for two Severity Level III violations for the licensee’s failure to: (1) notify the NRC within 24 hours after discovery of an unplanned contamination event that required access to contaminated areas to be restricted for more than 24 hours, as required by Title 10 of the Code of Federal Regulations (10 CFR) 30.50(b)(1); and (2) complete surveys and conduct or facilitate the cleanup of spills in accordance with its “Radioactive Material Contamination and Spill Clean-up” procedure, as required by Condition 19 of NRC License No. 13-35658-01MD.
On July 31, 2026, the U.S. Nuclear Regulatory Commission (NRC) issued a notice of violation (NOV) to Novartis Manufacturing, LLC, for two Severity Level III violations for the licensee’s failure to: (1) notify the NRC within 24 hours after discovery of an unplanned contamination event that required access to contaminated areas to be restricted for more than 24 hours, as required by Title 10 of the Code of Federal Regulations (10 CFR) 30.50(b)(1); and (2) complete surveys and conduct or facilitate the cleanup of spills in accordance with its “Radioactive Material Contamination and Spill Clean-up” procedure, as required by Condition 19 of NRC License No. 13-35658-01MD.
Corporate conductSettlementAgainst
The Federal Trade Commission approved a final order settling charges that Novartis AG's proposed acquisition of Fougera Holdings
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Novartis AG's proposed acquisition of Fougera Holdings, Inc. was anticompetitive in the markets for the marketing rights to four topical skin care medications.
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Novartis AG's proposed acquisition of Fougera Holdings, Inc. was anticompetitive in the markets for the marketing rights to four topical skin care medications.
Another example of this subterfuge came in 2012, when public reports touted a deal for Sandoz Inc. to acquire Fougera Pharmaceuticals, purportedly making Sandoz the largest seller of generic dermatology medicines both globally and in the United States. In reality, however, it was Novartis – not Sandoz – that signed the agreement and paid the $1.5 billion in cash to acquire Fougera.
Corporate conductSettlementAgainst
The Federal Trade Commission approved a final order settling charges that Novartis AG’s acquisition of Alcon
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Novartis AG’s acquisition of Alcon, Inc., as proposed, would have been anticompetitive in the U.S. market for certain eye care treatments.
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Novartis AG’s acquisition of Alcon, Inc., as proposed, would have been anticompetitive in the U.S. market for certain eye care treatments.
Novartis and Alcon are the only two U.S. providers of the class of drugs known as injectable miotics, and the FTC alleged that the acquisition would have created a monopoly in the market for these drugs.
Corporate conductSettlementAgainst
Novartis used the TAF, NORD, and CDF funds
Specifically, the United States alleges: At certain intervals during the period from January 1, 20 I 0, through December 31, 2014, Novartis used TAF as a conduit to pay kickbacks to Medicare patients taking Gilenya and used NORD and CDF as conduits to pay ldckbacks to Medicare patients taking Afinitor.
A federal court rejected Novartis Pharmaceuticals', a unit of Novartis AG (NYSE:NVS) legal challenge to the Medicare Drug Price Negotiation Program, ruling that the program does not violate constitutional protections against excessive fines, unlawful takings, or compelled speech.
Specifically, the United States alleges: At certain intervals during the period from January 1, 20 I 0, through December 31, 2014, Novartis used TAF as a conduit to pay kickbacks to Medicare patients taking Gilenya and used NORD and CDF as conduits to pay ldckbacks to Medicare patients taking Afinitor.
Subject to the exceptions in Paragraph 4 (concerning excluded claims) below, and conditioned upon Novartis' full payment of the Settlement Amount, the United States releases Novartis, together with its predecessors, and its current and former divisions, parents, subsidiaries, successors and assigns, from any civil or administrative monetary claim the United States has for the Covered Conduct under the False Claims Act, 31 U.S.C.
As a result of the foregoing conduct, the United States contends that Novartis caused false claims to be submitted to Medicare.
In consideration of the obligations of Novartis in this Agreement and the Corporate Integrity Agreement ("CIA") entered into between OIG-HHS and Novartis, and conditioned upon Novartis' full payment of the Settlement Amount, the OIG-HHS agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C.
Corporate conductRulingAgainst
Novartis AG resolved with the United States Securities
based on the Company’s and N ovartis AG’s remediation and the state of their compliance programs, and th e Company’s and Novartis AG’s agreement to report to the Fraud Section and the Office as set forth in the Reporting Requirements, the Fraud Section and the Office determined that an independent compliance monitor is unnecessary; f. Novartis AG, the Company’s parent company, has resolved with the United States Securities and Exchange Commission (the “SEC”) through a cease-and-desist proceeding relating to the conduct described in the attached Statement of Facts and other conduct, and has agreed to pay $92,300,000 in disgorgement and prejudgment interest of $20,500,000; g. the nature and seriousness of the offense conduct, as described in the Statement of Facts, including payments made in connection with the sponsorship of health care providers (“HCPs”) employed by p ublic institutions in Greece to attend international congresses a s a m e a n s t o b r i b e a n d c o r r u p t l y i n f l u e n c e t h e H C P s t o i n c r e a se prescriptions of a Novartis- branded drug and the falsification of books, records, and accou nts to conceal payments related to improper benefits and things of value and other improper paymen ts to HCPs, as well as the duration of the misconduct and the involvement of high-level sa les and business unit employees at the Company; h.
The Company shall not seek or accep t directly or indirectly reimbursement or indemnification from any source with regard to the penalty or disgorgement amou nts that the Company pays pursuant to this Agreement or any other agreement entered into with an enforcement authority or regulator, including the SEC, concerning the facts set forth in the attached Statement of Facts, except that the Company may seek reimbursement and indemnificat ion from its parent company, Novartis AG.
Novartis AG shall not seek or accept, directly or indirectly, reimbursement or indemnification from any source with regard to the penalty or disgorgement amounts that Novartis AG pays, directly or indirectly, including through reimbursement, to the Company, in association with this Agreement or any other agreement entered into with an enforcement authority or regulator, including the SEC, concerning the facts set forth in the attached Statement of Facts.
Specifically, NOVARTIS HELLAS falsely recorded as legitimate advertising and promotion expenses: (a) corrupt payments related to the international congresses described above; and (b) improper payments to HCPs related to an epidemiological study intended to increase sales of certain Novartis-branded prescription drugs.
the nature and seriousness of the offense conduct, as described in the Statement of Facts, including payments made in connection with the sponsorship of health care providers (“HCPs”) employed by p ublic institutions in Greece to attend international congresses a s a m e a n s t o b r i b e a n d c o r r u p t l y i n f l u e n c e t h e H C P s t o i n c r e a se prescriptions of a Novartis- branded drug and the falsification of books, records, and accou nts to conceal payments related to improper benefits and things of value and other improper paymen ts to HCPs, as well as the duration of the misconduct and the involvement of high-level sa les and business unit employees at the Company; h. Novartis AG’s March 2016 resolution of FCPA accounting alleg ations relating to similar conduct in China with the SEC; i. the Company has agreed to continue to cooperate with the Fra ud Section and the Office in any ongoing investigation as described in Paragraph 5 below; j. Accordingly, after considering (a) through (i) above, the Company received full cooperation and remediation credit, but because Novartis AG was involved in similar conduct 5
based on the Company’s and N ovartis AG’s remediation and the state of their compliance programs, and th e Company’s and Novartis AG’s agreement to report to the Fraud Section and the Office as set forth in the Reporting Requirements, the Fraud Section and the Office determined that an independent compliance monitor is unnecessary; f. Novartis AG, the Company’s parent company, has resolved with the United States Securities and Exchange Commission (the “SEC”) through a cease-and-desist proceeding relating to the conduct described in the attached Statement of Facts and other conduct, and has agreed to pay $92,300,000 in disgorgement and prejudgment interest of $20,500,000; g. the nature and seriousness of the offense conduct, as described in the Statement of Facts, including payments made in connection with the sponsorship of health care providers (“HCPs”) employed by p ublic institutions in Greece to attend international congresses a s a m e a n s t o b r i b e a n d c o r r u p t l y i n f l u e n c e t h e H C P s t o i n c r e a se prescriptions of a Novartis- branded drug and the falsification of books, records, and accou nts to conceal payments related to improper benefits and things of value and other improper paymen ts to HCPs, as well as the duration of the misconduct and the involvement of high-level sa les and business unit employees at the Company; h.
Novartis AG’s American Depository Shares were liste d and traded on the New York Stock Exchange under the symbol “NVS.” Novartis AG was an issuer of publicly traded securities registered pursuant to Section 12(b) of the Securities Exchange Act and was required to file periodic report s with the SEC under Section 13 of the Securities Exchange Act.
Novartis AG’s March 2016 resolution of FCPA accounting alleg ations relating to similar conduct in China with the SEC; i. the Company has agreed to continue to cooperate with the Fra ud Section and the Office in any ongoing investigation as described in Paragraph 5 below; j. Accordingly, after considering (a) through (i) above, the Company received full cooperation and remediation credit, but because Novartis AG was involved in similar conduct 5
Novartis AG acknowledges that no tax deduction may be sought in connection with the payment, reimbursement, or indemnification of any part of the Total Crim inal Fine in connection with this Agreement or the separate deferred prosecution agreement among the Fraud Section, the Office, and Alcon Pte Ltd, dated on or about June 25, 2020.
Specifically, NOVARTIS HELLAS falsely recorded as legitimate advertising and promotion expenses: (a) corrupt payments related to the international congresses described above; and (b) improper payments to HCPs related to an epidemiological study intended to increase sales of certain Novartis-branded prescription drugs.
As such, NOVARTIS HELLAS, through its employees and agen ts, knowingly and willfully conspired and agreed with others to cause the payments related to EXACTLY to be falsely recorded as legitimate expenses in Novartis AG’s books, records, and accounts.
Novartis AG’s American Depository Shares were liste d and traded on the New York Stock Exchange under the symbol “NVS.” Novartis AG was an issuer of publicly traded securities registered pursuant to Section 12(b) of the Securities Exchange Act and was required to file periodic report s with the SEC under Section 13 of the Securities Exchange Act.
Novartis AG acknowledges that no tax deduction may be sought in connection with the payment, reimbursement, or indemnification of any part of the Total Crim inal Fine in connection with this Agreement or the separate deferred prosecution agreement among the Fraud Section, the Office, and Alcon Pte Ltd, dated on or about June 25, 2020.
based on the Company’s and N ovartis AG’s remediation and the state of their compliance programs, and th e Company’s and Novartis AG’s agreement to report to the Fraud Section and the Office as set forth in the Reporting Requirements, the Fraud Section and the Office determined that an independent compliance monitor is unnecessary; f. Novartis AG, the Company’s parent company, has resolved wit h the United States Securities and Exchange Commission (the “SEC”) through a cease-and-desist proceeding relating to the conduct described in the attached Statement of Facts and other conduct, and has agreed to pay $92,300,000 in disgorgement and prejudgment interest of $20,500,000; g. the nature and seriousness of the offense conduct, as described in the Statement of Facts, including payments made in connection with the sponsorship of health care providers (“HCPs”) employed by p ublic institutions in Greece to attend international congresses a s a m e a n s t o b r i b e a n d c o r r u p t l y i n f l u e n c e t h e H C P s t o i n c r e a se prescriptions of a Novartis- branded drug and the falsification of books, records, and accou nts to conceal payments related to improper benefits and things of value and other improper paymen ts to HCPs, as well as the duration of the misconduct and the involvement of high-level sa les and business unit employees at the Company; h.
Novartis AG, the Company’s parent company, has resolved wit h the United States Securities and Exchange Commission (the “SEC”) through a cease-and-desist proceeding relating to the conduct described in the attached Statement of Facts and other conduct, and has agreed to pay $92,300,000 in disgorgement and prejudgment interest of $20,500,000; g. the nature and seriousness of the offense conduct, as described in the Statement of Facts, including payments made in connection with the sponsorship of health care providers (“HCPs”) employed by p ublic institutions in Greece to attend international congresses a s a m e a n s t o b r i b e a n d c o r r u p t l y i n f l u e n c e t h e H C P s t o i n c r e a se prescriptions of a Novartis- branded drug and the falsification of books, records, and accou nts to conceal payments related to improper benefits and things of value and other improper paymen ts to HCPs, as well as the duration of the misconduct and the involvement of high-level sa les and business unit employees at the Company; h.
As a result of this conduct, perpetrated by employees and agents of Novartis subsidiaries in China, Novartis violated Section 13(b)(2)(A) of the Securities Exchange Act of 1934 ("Exchange Act") by failing to make and keep books, records and accounts, which, in reasonable detail, accurately and fairly reflect the transactions and disposition of assets of the issuer.
As a result of the conduct described above Novartis violated Section 13(b)(2)(B) of the Exchange Act, which requires issuers that have a class of securities registered pursuant to Section 12 of the Exchange Act and issuers with reporting obligations pursuant to Section 15(d) of the Exchange Act to devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary (I) to permit preparation of financial statements in conformity with generally accepted accounting principles or any other criteria applicable to such statements, and (II) to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
The Securities and Exchange Commission (“Commission”) deems it appropriate that cease- and-desist proceedings be, and hereby are, instituted pursuant to Section 21C of the Securities Exchange Act of 1934 (“Exchange Act”), against Novartis AG (“Novartis” or “Respondent”). II. In anticipation of the institution of these proceedings, Respondent has submitted an Offer of Settlement (the “Offer”) which the Commission has determined to accept.
As a result of the conduct described above, Novartis violated Section 13(b)(2)(A) of the Exchange Act, which requires issuers that have a class of securities registered pursuant to Section 12 of the Exchange Act and issuers with reporting obligations pursuant to Section 15(d) of the Exchange Act to make and keep books, records, and accounts which, in reasonable detail, accurately and fairly reflect their transactions and disposition of their assets.
As a result, Novartis violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act of 1977 (the “FCPA”) [15 U.S.C. § 78m], and was unjustly enriched by approximately $92.3 million.
15 Payments by check or money order must be accompanied by a cover letter identifying Novartis as a Respondent in these proceedings, and the file number of these proceedings; a copy of the cover letter and check or money order must be sent to Tracy L. Price, FCPA Deputy Unit Chief, Division of Enforcement, Securities and Exchange Commission, 100 F St., NE, Washington, DC 20549-5631.
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