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- Title
Development of orphan vaccines: an industry perspective.
- Authors
Lang, Jean; Wood, Susan C.; Lang, J; Wood, S C
- Abstract
The development of vaccines against rare emerging infectious diseases is hampered by many disincentives. In the face of growing in-house expenditures associated with research and development projects in a complex legal and regulatory environment, most pharmaceutical companies prioritize their projects and streamline their product portfolio. Nevertheless, for humanitarian reasons, there is a need to develop niche vaccines for rare diseases not preventable or curable by other means. The U.S. Orphan Drug Act of 1983 and a similar proposal from the European Commission (currently under legislative approval) provide financial and practical incentives for the research and development of drugs to treat rare diseases. In addition, updated epidemiologic information from experts in the field of emerging diseases; increased disease awareness among health professionals, patients, and the general public; a list of priority vaccines; emergence of a dedicated organization with strong leadership; and the long-term pharmacoeconomic viability of orphan products will be key factors in overcoming the complexity of orphan status and the limited need for vaccine.
- Subjects
UNITED States; VACCINES; ORPHAN drugs; VACCINATION; DRUG approval laws; EUROPEAN Union; HEALTH policy; DRUG approval; ECONOMICS
- Publication
Emerging Infectious Diseases, 1999, Vol 5, Issue 6, p749
- ISSN
1080-6040
- Publication type
journal article
- DOI
10.3201/eid0506.990602