Pharma Companies Under Government Investigation
Company	Investigation
AbbVie	Alaska Attorney General's Office served a civil investigative demand, primarily seeking documents AbbVie produced in the Federal Trade Commission's suit against AndroGel patent litigation settlement; suit was dismissed in May 2015.
Allergan	In April 2015 Allergan's Forest subsidiary received a subpoena from HHS' Office of Inspector General requesting documents relating to average manufacturer and best price calculations for several of its products. In June 2015 the company's Actavis subsidiary received a subpoena from DOJ seeking information relating to the marketing and pricing of certain generic products and its communications with competitors about the products (Teva assumed liability with its acquisition of Allergan's generic business). Allergan has received investigatory subpoenas from the US Attorney's Office and various state agencies requesting information and documents relating to categories of drug pricing, including average wholesale price, wholesale acquisition cost, average manufacturer price and best price.
AstraZeneca	In May 2012 its MedImmune unit received a subpoena form the Office of Attorney General for the State of Florida Medicaid and Fraud Control Unit requesting sales and marketing documents for its respiratory tract disease treatment Synagis (palivizumab). In June 2011 MedImmune received a demand from the US Attorney's Office for the Southern District of NY requesting documents related to Synagis and also received a court order to produce the documents for the Office of the Attorney General for the State of New York Medicaid and Fraud Control Unit.
Biogen	In March 2016 received a subpoena from the federal government for documents relating to the company's relationship with non-profit organizations that provide assistance to patients taking Biogen drugs. In July received civil investigative demands from the federal government for documents and information relating to treatment of certain service agreements with wholesalers when calculating and reporting average manufacturing prices in connection with the Medicaid drug rebate program.
Celgene	In December 2015 received a subpoena from the US Attorney's Office for the District of Massachusetts requesting documents related to its support of 501(c)(3) organizations that provide financial assistance to patients.
Eli Lilly	US Attorney's Office for the Eastern District of Pennsylvania and the DOJ are conducting an inquiry of Lilly's treatment of certain distribution service agreements with wholesalers when calculating and reporting average manufacturer prices in connection with the Medicaid drug rebate program. Lilly was notified of the probe in September 2015.
Gilead	In February 2016 received a subpoena from the US Attorney's Office for the District of Massachusetts requesting documents related to its support of 501(c)(3) organizations that provide financial assistance to patients and its provision of financial assistance to patients for hepatitis C virus products. Massachusetts Attorney General served Gilead with a civil investigative demand in February requesting documents related to its HCV products and in July suspended Gilead's obligations under the CID until further notice.
GlaxoSmithKline	In February 2016 the US Attorney's Office for the Southern District of New York issued a subpoena requesting documents related to GSK's vaccine business and in March 2016 it issued a subpoena requesting documents relating to US contracts for its migraine treatments Imitrex (sumatriptan) and Amerge (naratriptan).
Jazz Pharmaceutical	In May 2016 received a subpoena from the US Attorney's Office for the District of Massachusetts requesting documents related to the company's support of 501(c)(3) organizations that provide financial assistance to Medicare patients and for documents regarding financial assistance to Medicare patients for its narcolepsy drug Xyrem (sodium oxybate).
Johnson & Johnson	In March 2016 its Janssen Pharmaceuticals unit received a civil investigative demand from the US Attorney's Office for the Southern District of New York related to Janssen's contractual relationships with pharmacy benefit managers from Jan. 1, 2006 to the present with regard to certain products. In August 2015 the New Hampshire Attorney General subpoenaed Janssen and other pharma companies related to opioid marketing practices. In March 2016 New Hampshire Superior Court denied the state's motion to enforce the subpoena and granted a protective order on grounds the state had not obtained approvals to retain private counsel. The parties appealed the ruling and the AG's office obtained approvals for private counsel.
Mylan	In December 2015 received a subpoena from DOJ's antitrust division seeking information relating to the marketing, pricing and sale of its generic doxycycline products and any communications with competitors about them. The company also received a subpoena from the Connecticut Office of the Attorney General seeking information about doxycycline and its other generic products. And in September the New York Attorney General's Office began an investigation of its EpiPen sales contracts.
Novartis Pharmaceuticals	In 2013 the government filed a civil complaint intervening in a False Claims Act action involving marketing practices for several cardiovascular medicines. The probe is related to a 2011 investigation by the US Attorney's Office for the Southern District of New York. In 2013 received a civil investigative demand from the US Attorney's Office for the Southern District of New York requesting documents and information related to marketing practices for its multiple sclerosis drug Gilenya (fingolimod), including the remuneration of healthcare providers.
Sanofi	In June 2012 DOJ began investigating disclosures to the FDA regarding the variability of response to the blood thinner Plavix (clopidogrel).
Valeant	In March 2016 received an investigative demand from the North Carolina Department of Justice for materials relating to Nitropress (nitroprusside), Isuprel (isoproterenol) and Cuprimine (penicillamine), including documents regarding production, marketing, distribution, sales and pricing, and patient assistance programs. In October 2015 received subpoenas from the US Attorney's offices for the District of Massachusetts and the Southern District of New York for documents relating to patient assistant programs; its former relationship with Philidor and other pharmacies; accounting treatment for sales by specialty pharmacies; information provided to the Centers for Medicare and Medicaid Services; pricing, including discounts and rebates, marketing and distribution of its products; its compliance program; and employee compensation. In September 2015 received a letter from DOJ's civil division and the US Attorney's Office for the Eastern District of Pennsylvania regarding investigation of Biovail Pharmaceutical's treatment of certain service agreements with wholesalers when calculating and reporting average manufacturer prices in connection with the Medicaid drug rebate program.
Source: Company SEC filings

Pharma Pricing, Non-Profit Ties Get Increasing Scrutiny From Prosecutors

More from Legal & IP

More from Pink Sheet