House E&C Questions Insulin Manufacturers

Regulatory NewsRegulatory News | 30 January 2019 |  By 

The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin.

First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes.

Now, just a day after two mothers testified before House and Senate committees on the dangers behind the rising price of insulin, E&C Chair Frank Pallone (D-NJ) and Subcommittee on Oversight Chair Diana DeGette (D-CO) want to know why prices have skyrocketed.

“What are the root causes of rising prices for insulin?” the letters ask, in addition to seeking more information on the factors that led to the price increases, barriers to lowering prices and how the companies expect the market to change over the next five years.

Companies have until 13 February to respond.

Last January, these same three drugmakers also received letters from DeGette and Rep. Tom Reed (R-NY) concerning insulin discount programs, which are designed to help lower out-of-pocket costs.

Meanwhile, the US Food and Drug Administration (FDA) has kicked off efforts to begin, starting in March 2020, transitioning the approved marketing applications for a subset of biological products, such as insulins and human growth hormone – which were previously approved as drugs under section 505 of the FD&C Act – to be biologics. FDA Commissioner Scott Gottlieb has said such a transition will help to speed the onset of newer insulin biosimilars in the US.


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