25 Years of the Orphan Drug Act


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There have been many clinical and marketing achievements since Jan. 4, 1983, when the Orphan Drug Act (ODA) was passed. In the past two and half decades more than 1,800 treatments have been designated with Orphan Drug status, and 319 products have been approved by the Food and Drug Administration compared with a mere 10 products developed before 1983.
The ODA provides development incentives to companies through tax credits for the cost of clinical research, grant funding to defray the costs of clinical testing, assistance in clinical research design, seven-year exclusivity for marketing the orphan drug, and a waiver of the Prescription Drug User Fee Act filing fees…

Global Reimbursement Issues
FDA and the Orphan Drug Act
Orphan Drugs in Development

Experts on this Topic
Michael A. Boss, Ph.D. Chief Business Officer, Xanthus Pharmaceuticals Inc., Cambridge, Mass.; Xanthus is a biopharmaceutical company focused on the discovery, development, acquisition, and commercialization of small-molecule therapeutics for the treatment of cancer and autoimmune disorders. For more information, visit
Michael Burke. Chief Commercial Officer, Ovation Pharmaceuticals Inc., Deerfield, Ill.; Ovation is a biopharmaceutical company that develops, manufactures, and markets therapies for severely ill patients with unmet medical needs. The company focuses on central nervous system, hematology/oncology, and hospital-based therapies. For more information, visit
Timothy Coté, M.D., MPH. Director, Office of Orphan Products Development (OOPD), Food and Drug Administration, Rockville, Md.; The FDA is responsible for protecting the
public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. For more information, visit
Robert Glik. Senior Principal of Pricing and Reimbursement, IMS Health, Norwalk, Conn.; IMS Health is a provider of market intelligence to the pharmaceutical and healthcare industries. For more information, visit