A puzzling tsunami entered Japanese history in January 1700. Samurai, merchants, and villagers wrote of minor flooding and damage. Some noted that no parent earthquake had been felt; they were wondering what had set off the waves. They had no way knowing that the tsunami had been spawned during an earthquake along the coast of northwestern North America. This orphan tsunami would not be linked to its parent earthquake until the middle 1990s, through an extraordinary series of discoveries in both North America and Japan.
For rural referral centers, sole community hospitals, critical access hospitals, and free-standing cancer hospitals participating in the 340B Program, the term "covered outpatient drug" doesn't include a drug designated by the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or condition.
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Therefore, manufacturers aren't required to provide these covered entities' orphan drugs under the 340B Program. A manufacturer may, at its sole discretion, offer discounts on orphan drugs to these hospitals.
HRSA develops this list and updates it quarterly. It is based upon specific fields captured from the list of orphan drug designations provided by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD). The list posted should be the source used by 340B stakeholders to ensure compliance with the orphan drug exclusion. Covered entities may need to conduct additional analyses of the drugs provided on this list to determine the appropriate orphan drugs to exclude from the 340B Program.
HRSA recognizes that orphan drug designation sponsors listed on the FDA orphan drug list may not be the current manufacturer for an orphan drug. The sponsor listed reflects the latest information reported by the sponsor to the FDA OOPD. HRSA encourages 340B stakeholders to work, in good faith, to resolve any potential disputes that may result from the use of this list. HRSA will continue to improve the list that is posted on a quarterly basis to ensure covered entities have the information they need to comply with the orphan drug exclusion.
Around the world, millions of children are separated from their parents, missing the love, care and sense of belonging only family can provide. The Body of Christ has a unique call to care for the orphan, but it can be difficult to know how best to respond.
The Faith to Action Initiative offers practical tools and resources, inspiring stories and examples, and up-to-date information on key strategies and research to help guide action toward caring for orphans and vulnerable children. Start learning here.
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This page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan designation, and dates. Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet.Click for detailed instructions.
You can download the European Medicines Agency's (EMA) medicine-related data published on this website in Excel table format from this page. EMA updates these medicine data tables once a day.
An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by EMA's Committee for Orphan Medicinal Products (COMP), which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question.
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