Office of Orphan Product Development

The Office of Orphan Products Development (OOPD) is dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions since 1982. OOPD interacts with the medical and research communities, professional organizations, academia, and the pharmaceutical industry, as well as rare disease groups. The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. The ODA has been very successful - over 300 drugs and biological products for rare diseases have been brought to market since 1983. In contrast, the decade prior to 1983 saw fewer than ten such products come to market. In addition, the OOPD administers the Orphan Products Grants Program which provides funding for clinical research in rare diseases; and the Pediatric Device Consortia (PDC) Grant Program which provides support to nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices.