orphan drug

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orphan drug,

drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the development and manufacturing of such drugs, which otherwise might not be profitable because of the small potential market. (Of the 5,000 diseases covered under the act, 47% affect fewer than 25,000 people.) The law has led to the introduction of valuable new drugs for the treatment of rare diseases, but some drug companies have been accused of abusing the law's provisions by making inordinately high profits on orphan drugs under monopoly. Since the 1983 act went into effect, many orphan drugs have been approved, including those for the treatment of such conditions as AIDSAIDS
or acquired immunodeficiency syndrome,
fatal disease caused by a rapidly mutating retrovirus that attacks the immune system and leaves the victim vulnerable to infections, malignancies, and neurological disorders. It was first recognized as a disease in 1981.
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, cystic fibrosiscystic fibrosis
, inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males.
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, blepharospasm (uncontrolled rapid blinking), and snake bite.

orphan drug

[¦ȯr·fən ′drəg]
(pharmacology)
A pharmaceutical developed to treat a disease that afflicts relatively few people.
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References in periodicals archive ?
The FDA Office of Orphan Products Development manages a grant program to help drug development for rare conditions.
The legislation will provide incentives to the European pharmaceutical industry in terms of research and development assistance (protocol assistance, normal evaluation, possible form of centralized but fast-track approval procedures), fee waiver, tax credits, funds from the European Orphan Product Grant Program, and market exclusivity for 10 years (interim period 6 years) and will encourage national policies (subsidiary principle, e.
and Orrin Hatch (R-Utah) claim that manufacturers are abusing the provisions by charging high prices for their orphan products.
The FDA awards the grants through the Orphan Products Clinical Trials Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.
1379 will fortify the ORD by making it a permanent office at NIH; giving it statutory authority which will allow it to form its own research agenda; doubling its budget to $4 million in Fiscal Year 2002 and "such sums as may be necessary" for each subsequent fiscal year; authorizing new funds for Rare Disease Research Centers of Excellence in the amount of $20 million; and doubling the funding of the Orphan Product Research Grant Program at the FDA-which receives 100 grant applications yearly-to $25 million in FY 2002.
The FDA awards orphan product classification to new approaches that may offer therapeutic value for the treatment of rare diseases and conditions.
And it held an exchange of views with Dr Marlene Haffner, Director of the Office for Orphan Product Development at the US Food and Drug Administration, which has 17 years of experience with orphan drugs.
Food and Drug Administration (FDA) Orphan Product Designation in the United States and received the Rare Pediatric Disease Designation as a pre-requisite part of the FDA's Priority Review Voucher (PRV) process.
We are recommending the federal government finally recognize Canada needs a national Orphan Product Policy to set a standard of equality for Canadians with rare and life-threatening conditions.
ABO-101 has previously been granted the US Food and Drug Administration (FDA) Orphan Product Designation in the United States and received the Rare Pediatric Disease Designation as a pre-requisite part of the FDA's Priority Review Voucher (PRV) process.
director of the FDA s Office of Orphan Product Development.