Washington, D.C. – U.S. Senators Catherine Cortez Masto (D-Nev.), Susan Collins (R-Maine), and Claire McCaskill (D-Mo.) sent a letter to Robert DiCrisci, the CEO of Tri-Source Pharma, seeking additional information on a significant price spike for the 40-year-old, off-patent cancer drug lomustine. NextSource Biopharmaceuticals, a subsidiary of Tri-Source Pharma, acquired lomustine and increased the price 1,400 percent over a four-year period.
“…[W]e want to learn more about NextSource Biotechnology LLC’s acquisition of the rights to sell lomustine, a prescription drug used to treat brain tumors and Hodgkin lymphoma,” Senators Cortez Masto, Collins, McCaskill wrote. “In particular, we would like to better understand the factors contributing to the rising cost of lomustine, which has increased nearly 1,400 percent since 2013 for the highest dose.”
Lomustine was originally approved by the FDA in 1976 for treatment of brain tumors and Hodgkin lymphoma. It is one of only four FDA-approved treatments for glioblastoma, the most common and deadliest form of malignant brain tumor in adults. It is also used off-label to treat other forms of cancer.
A full copy of the letter can be found HERE and below:
Dear Mr. DiCrisci:
Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate. We seek your cooperation so that we may better understand drug pricing and related regulatory and public policy concerns.
As Chairman and a Member of the Special Committee on Aging and Ranking Member of the Committee on Homeland Security and Governmental Affairs, we want to learn more about NextSource Biotechnology LLC’s acquisition of the rights to sell lomustine, a prescription drug used to treat brain tumors and Hodgkin lymphoma. In particular, we would like to better understand the factors contributing to the rising cost of lomustine, which has increased nearly 1,400 percent since 2013 for the highest dose.
In order to assist us in our investigation, we ask that you provide us with the following documents and information for the time period from January 1, 2011, to the present:
(1) the company’s gross and net revenues from sales of lomustine on an annual basis, including but not limited to specific amounts received from any federal, state, or local program and from any related entities;
(2) the company’s expenses relating to sales of lomustine on an annual basis, including but not limited to specific amounts expended for manufacturing, purchases of active pharmaceutical and other ingredients, research and development, FDA and other regulatory agency approval, marketing and advertising, and any unusual or non-recurring expenses;
(3) the company’s profits from sales of lomustine on an annual basis;
(4) all documents and communications referring or relating to cost estimates, profit projections, market share analysis, and other internal or external analyses relating to the company’s current or future sales of this drug;
(5) copies of all documents previously produced or to be produced in response to requests received from any other governmental entities; and
(6) a list of all drugs sold by the company and relevant pricing information for any of such drugs that have increased in price by at least 200 percent in a single year.
Please provide the requested documents and information as soon as possible, but by no later than April 6, 2018.
In order to facilitate this production, please schedule a time to confer with our staff as soon as it is practicable.