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In Reply

Tufts Center for the Study of Drug Development, Tufts University, Medford, MA

Henry G. Grabowski

Department of Economics, Duke University, Durham, NC

Dr Tidmarsh is correct that Table 1 in our article¹ does not contain Doxil (Ortho Biotech Products, Bridgewater, NJ), but this is not an error. The table is a list of therapeutic new chemical entities and corresponding therapeutically significant new biologics first approved by the US Food and Drug Administration from 1990 to 2005 for oncology indications. Doxil is a new (liposomal) formulation, not a new chemical entity. Doxorubicin, the active ingredient in Doxil, was first approved by the US Food and Drug Administration in 1974 under the trade name Adriamycin (Pfizer Inc, New York, NY). Thus, neither Adriamycin nor Doxil met the criteria for inclusion in the table. Undoubtedly, the approval of Doxil represented an important milestone in the history of the accelerated approval process for oncology drugs, and some new formulations are important clinical advances over existing formulations of the same drugs. However, our analyses (and the data that we had available for those analyses) were about first approvals of new active ingredients, not every product variant developed during a drug's life cycle.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

REFERENCE

1. DiMasi JA, Grabowski HG: Economics of new oncology drug development. J Clin Oncol 25:209-216, 2007[Abstract/Free Full Text]

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Related Correspondence

• Liposomal Doxorubicin and the Accelerated Approval Process
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