Pharma Firms Facing Government Probes
Company		Investigation
Allergan		On April 18, 2017, received a civil investigative demand from the Department of Justice for information related to sales and marketing practices of Botox to urology practices. On Oct. 16, 2017, received a CID from the North Carolina Department of Justice seeking information relating to Watson's reporting of AMP calculations. The state has reserved its right to intervene in a qui tam complaint that was unsealed in January. Allergan received subpoenas from multiple states relating to legacy Actavis and Watson companies' promotional efforts for opioid products. It has received information requests from regulatory agencies and the House Committee on Oversight and Government Reform concerning its Restasis agreements with the Saint Regis Mohawk Tribe.
AstraZeneca		In June 2011, MedImmune subsidiary received a demand from the US Attorney's Office of the Southern District of New York for documents related to Synagis sales and marketing activities and a similar court order in July 2011 from the New York AG. In May 2012, MedImmune received a subpoena from the Florida AG Medicaid and Fraud and Control Unit for Synagis documents. In October 2014, Texas AG intervened in a suit alleging inappropriate promotion of Seroquel and improper payments intended to influence Seroquel's formulary status. In January 2015, AstraZeneca was served with a suit in which the Texas AG's office intervened alleging inappropriate promotion of Crestor and improper influencing of Crestor's formulary status.
Biogen		Federal government has issued subpoenas and other requests for documents and information relating to Biogen's relationship with nonprofit organizations who provide assistance to patients taking its drugs and to Biogen's co-pay assistance programs. In July 2016, received civil investigative demands from the federal government for documents and information relating to certain service agreements with wholesalers when calculating and reporting average manufacture prices in connection with the Medicaid Drug Rebate Program.
GlaxoSmithKline		On Feb. 25, 2016, received a subpoena from the US Attorney's Office for the Southern District of New York requesting documents related to its vaccines business. On March 7, 2016 received a subpoena from the same office requesting documents relating to its US contracts for Imitrex and Amerge.
Gilead Sciences		In February 2016, received a subpoena from the US Attorney's Office for the District of Massachusetts requesting documents for its support of 501(c)(3) organizations that provide financial assistance to patients and documents concerning Gilead's financial assistance to patients for its HIV products. In October 2017, received a subpoena from the same office requesting documents related to its copay coupon program and Medicaid price reporting methodology. In September 2017, received a voluntary request for information from the US Attorney's Office for the Eastern District of Pennsylvania related to its reimbursement support offerings, clinical education programs and interactions with specialty pharmacies for Sovaldi and Harvoni. In October 2017, received a subpoena from the California Department of Insurance and the Alameda County District Attorney's Office requesting documents related to marketing activities, reimbursement support offerings, clinical education programs and interactions with specialty pharmacies. In November 2017, received a subpoena from US Department of Health and Human Services requesting documents related to its Frontlines of Communities in the United States (FOCUS) program and a subpoena from the US Attorney's Office for the Southern District of New York for documents related to its promotional speaker programs for HIV. In June 2018, received another voluntary request for information related to its speaker programs and advisory boards for HCV and hepatitis B virus products.
Johnson & Johnson		Received subpoenas or requests for information related to opioids marketing practices from eight state attorneys general. In March 2017, received subpoena from the US Attorney's Office for the District of Massachusetts for records pertaining to payments to 501(c)(3) charitable organizations that provide financial assistance to Medicare patients. In March 2017, received CID from DOJ regarding False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased Remade or Simponi Aria. In April and September 2017, received subpoenas from the US Attorney for the District of Massachusetts seeking documents relating to copayment support programs for Darzalex, Olysio, Remicade, Simponi, Stelara and Zytiga and documents relating to Average Manufacturer Price and Best Price reporting to CMS and rebate payments to Medicaid agencies. In Sept. 2017, was contacted by Texas and California attorney general's offices on behalf of approximately 38 states regarding a multi-state AG investigation. In March 2016, Janssen received a CID from the US Attorney's Office for the Southern District of New York related to its contractual relationships with pharmacy benefit managers from Jan. 1, 2006 to the present.
Mylan		On Dec. 3, 2015, a Mylan subsidiary received a subpoena from DOJ's antitrust division for information relating to the marketing, pricing and sale of generic doxycycline products and any communications with competitors. On Dec. 21, 2015, received a subpoena and interrogatories from the Connecticut AG's Office for information on marketing, pricing and sale of certain generic products, including doxycycline, and communications with competitors. On Sept. 8, 2016, a subsidiary received additional subpoenas from DOJ for information on sales, marketing and pricing of generic cidofovir, glipizide-metformin, propranolol and verapamil. On Nov. 18, 2016, received a request from the Federal Trade Commission for documents relating to its preliminary investigation into anticompetitive practices relating to epinephrine auto-injectors. On Dec. 14, 2016, AGs of 20 states filed complaint against Mylan and other generic manufacturers alleging anticompetitive conduct. On Oct. 7, 2016, received request from Securities and Exchange Commission for communications with the Centers for Medicare and Medicaid Services and documents concerning Mylan products sold and related to the Medicaid Drug Rebate Program. On June 30, 2017, responded to a request for information from the Department of Veterans Affairs requesting historical pricing data related to the EpiPen Auto-Injector. On July 27, 2017, received a subpoena from DOJ seeking information on opioids marketed by Mylan from Jan. 1, 2013 to Dec. 31, 2016. On Aug. 29, 2017, received a CID from the Missouri AG for information on opioids marketed from Jan. 1, 2010 to the present. On April 9, 2018, a Mylan subsidiary received a CID from DOJ's Commercial Litigation Branch concerning its Trade Agreements Act compliance for certain products. On May 10, 2018 received CID from DOJ's civil division seeking information relating to the pricing and sale of its generic products.
Novartis		In 2016 and 2017, subsidiary Sandoz received subpoenas and interrogatories from the DOJ antitrust division and the attorney general of Connecticut requesting documents related to the marketing and pricing of generic products and related communications with competitors. In 2016 and 2017, Novartis received subpoenas from the US Attorney's Office for the District of Massachusetts requesting documents related to its support of 501(c)(3) organizations that provide co-payment assistance to Medicare patients who are prescribed Novartis medicines, and related to pricing strategies for Gleevec, Tasigna, Zometa and Gilenya.
Novo Nordisk		In March 2016, DOJ served Novo with a CID for documents and information regarding haemophilia-related patient support programs and information relating to the marketing and promotion of NovoSeven RT. In March 2016, the US Attorney's Office for the Southern District of New York served a CID for documents and information regarding Novo's contracts and business relationships with PBMs concerning NovoLog, Novolin and Levemir. On Jan. 18, 2017, Minnesota AG's Office served a CID for documents and information relating to pricing and trade practices for Novo's long acting insulin products, including Levemir and Tresiba, from Jan. 1, 2008 to the present. On March 7, 2017, Washington State AG's Office served CID for documents and information relating to pricing and trade practices for insulin products from Jan. 1, 2005 to the present. On April 26, 2017, New Mexico State AG's Office served CID for documents and information regarding trade practices and pricing for NovoLog and Novolin from Jan. 1, 2012 to the present.
Pfizer		In March 2016, received CID from the US Attorney's Office for the Southern District of New York related to Pfizer's contractual relationships with PBMs from Jan. 1, 2006 to the present. In July 2018, was served with qui tam complaint that appears to be related to the investigation and in which the government declined to intervene. As of July 2017, the DOJ's antitrust division has been investigating Pfizer's Greenstone generics business. In April 2018, Greenstone received requests for information from the Connecticut AG's Office.
Sanofi		In February 2016, received a CID from the US Attorney's Office for the Northern District of Texas requesting documents and information relating to contracts with specialty pharmacies concerning Renvela and Renagel from Jan. 1, 2006 through Feb. 1, 2016. In March 2016, received CID from US Attorney's Office for the Southern District of New York for documents relating to contracts with, services performed by, and payments to PBMs regarding Lantus and Apidra from Jan. 1, 2006 going forward. In January 2017, the Minnesota AG's Office issued CID for documents relating to pricing and trade practices for Lantus ad Toujeo from Jan. 1, 2008 through the present. In March 2017, Washington state AG's office issued CID for documents relating to pricing and trade practices for injectable insulin products from Jan. 1, 2005 to the present. In January 2018, received subpoena from the US Attorney's Office for the District of Massachusetts for documents relating to relationship with non-profit organizations that provide assistance to patients taking Sanofi drugs and Sanofi's US patient assistance programs as well as documents relating to the sale and marketing of Aubagio and Lemtrada.
Takeda		In November 2016 US Attorney's Office in Boston issued a subpoena to Ariad, which Teva acquired during the year ended March 31, 2017, seeking information from January 2010 to the present related to its donations to 501 (c)(3) co-payment foundations, financial assistance programs, and free drug programs available to Medicare beneficiaries, and information on the relationships between these copayment foundations and specialty pharmacies, hubs or case management programs.
Teva		On June 21, 2016, Teva received a subpoena from DOJ's antitrust division for documents and information relating to the marketing and pricing of certain US generic products and communications with competitors. Actavis received a similar subpoena in June 2105. On July 12, 2016, Teva received a subpoena from the Connecticut AG seeking documents and information relating to potential antitrust violations. Actavis received a similar subpoena. On Dec. 15, 2016, AGs of 20 states filed civil action against Teva USA and several other companies alleging price fixing of generic products. A new complaint on behalf of additional states was filed in July 2017, and on June 5, 2018, a district court granted motion by AGs of 45 states, Puerto Rico and District of Columbia to amend the complaint. On March 21, 2017, received a subpoena form the US Attorney's Office in Boston requesting documents related to Teva's donations to patient assistance programs. On April 27, 2018 Teva received subpoena requests from the DOJ seeking documents relating the the manufacture, marketing and sale of opioiods. State AGs have also initiated investigations into Teva's sales and marketing of opioids. In May 2018, received a CID from DOJ seeking documents produced since Jan. 1, 2009 relevant to investigation of allegations that Teva and other generic manufacturers engaged in market allocation and price-fixing agreements, paid illegal remuneration and caused false claims to be submitted.

Government Pharma Investigations Target Pricing, Opioids, Trade Practices

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