Eli Lilly and Co., Sanofi and Novo Nordisk A/S have received subpoenas from the New York attorney general's office regarding the pricing and sale of their insulin products.
According to the pharma companies' respective filings, the subpoenas, received in July 2019, are part of an inquiry investigating their pricing practices, a subject that garnered national attention when U.S. lawmakers demanded answers for the insulin products' high prices.
Sanofi reported in its half-year report that the subpoena has requested documents pertaining to the French drugmaker's insulin pricing, discount programs, sales and expenses, contracting, marketing materials and legal proceedings.
Lilly, Sanofi and Novo Nordisk have been named as defendants in two lawsuits in the U.S. District Court of New Jersey that relate to insulin pricing. Sanofi said the manufacturers have filed a motion to dismiss the suits. The lawsuits allege a violation of consumer protection laws, common law fraud and unjust enrichment, according to the Federal Racketeer Influenced and Corrupt Organization Act.
In the same court, the Minnesota attorney general's office filed a similar complaint against the three companies in October 2018, under state laws and the RICO Act. The Kentucky attorney general's office also filed a suit in Kentucky state court, as of May.
Lilly, Sanofi and Novo Nordisk comprise 96% of the world's insulin market, according to Kentucky Attorney General Andy Beshear, who said insulin costs $2.28 to $6.34 per vial to make. However, the average wholesale price is about $300.
Beshear wrote in the complaint that Danish company Novo Nordisk's Novolog Flex Pen increased in price by 218%, from $255.74 per package in July 2012 to $558.83 per package in July 2018.
The price of Sanofi's Apidra injection rose by 311% from December 2010 to January 2019, and the cost of its market-leading Lantus insulin jumped 285% during the same period. Lilly's Humalog pen increased from $235.80 per package in November 2011 to $530.40 per package in May 2017.
The Minnesota attorney general's office said in an October 2018 press release that the drugmakers set two prices for their insulin products: an "artificially high" list price and a lower negotiated price arranged with pharmacy benefit managers. The disparity between these two prices has nearly doubled, and sometimes increased seven-fold, in recent years, according to Minnesota's suit.
Eli Lilly said in its Aug. 2 quarterly report that "these claims are without merit." Sanofi noted that the companies are preparing motions for dismissal of the complaints from Kentucky and Minnesota.
In addition to the lawsuits, Lilly has received civil investigative demands from attorneys general in Washington and New Mexico. Attorneys general in Mississippi, California, Florida, Hawaii, Nevada and Washington, D.C., have all requested information from Lilly on its pricing and sale of insulin products.
Lilly said it is cooperating with requests for commercial information and pricing practices from multiple government committees. These include the Energy and Commerce Committee and the Oversight and Reform Committee in the House; and the Health, Education, Labor, and Pension Committee and the Finance Committee in the Senate.