Congressional Investigation of RevAssist-Linked and General Pricing Strategies for Lenalidomide

Funding

Although manufacturers report price hikes responding to research and development costs, the report contradicts this. Lenalidomide's research and development was funded mostly by federal grants to Rockefeller University (for thalidomide). After purchasing thalidomide, Boston Children's Hospital identified lenalidomide benefits with a $2.3-million USD National Institute of Health grant to Dana Farber. Federally funded trials by the Eastern Cooperative Oncology Group and Mayo Clinic supported the 2006 FDA approval of lenalidomide for multiple myeloma. Memoranda indicated that Celgene invested in lenalidomide following on National Cancer Institute\u2013 and Mayo Clinic\u2013funded clinical trials. A 2017 FDA approval for lenalidomide for multiple myeloma after high-dose melphalan with autologous stem-cell transplant resulted from a federally funded US Alliance for Clinical Trials in Oncology study. More than half of the trials Celgene reported as supporting price increases in 2016 to 2018 were funded by non-Celgene entities. The Committee cited manufacturers of pregabalin and ibrutinib as other examples where federal funding supported drug development. The Committee noted in 2021 that the world's 14 largest drug companies spent more compensating executives and investors than on research and development. Supported in part by Arnold Ventures (C.L.B., J.B.G., A.T.), the National Cancer Institute to the University of South Carolina (1R01 CA102713; C.L.B.), the National Institutes of Health/National Cancer Center Support Grant (P30CA033572; S.T.R.) to the City of Hope, Duarte, Ca, Duarte, California (S.T.R.), and a Visiting Scholar award from the Beckman Research Institute of the City of Hope National Medical Center (C.L.B.), Duarte, CA. The authors thank Gerard Anderson, PhD; Virginia M. Green, PhD; Joseph Magagnoli, MS; Laura Karas, MD, MPH, and William Hrushesky, MD, for helpful comments on earlier versions of this manuscript.