Orphan drug

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orphan drug

Etymology: Gk, orphanos, without parents; ME, drogge
a term that generally refers to drugs needed to treat rare diseases but can encompass any pharmaceutic product available to physicians and patients in countries other than the United States that has not been "adopted" by a domestic pharmaceutic manufacturer or distributor. An orphan drug may not be available in the United States because total sales would not justify the expense of research and development or because the medication may be a natural substance that cannot be effectively protected by patent laws against competition from a similar form of the product. The U.S. Orphan Drug Act of 1983 offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the United States for rare diseases affecting fewer than 200,000 people. The FDA assists in the process with its office of Orphan Product Development.
Any drug, biological, medical device, or food of potential or actual use in treating ‘orphan’ diseases—diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products

orphan drug/product

Any drug, biological, medical device, or food of potential or actual use in treating 'orphan' diseases–diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products. See Orphan disease. Cf Pseudoorphan drug.

Orphan drug

A term for a drug that treats a rare disease, defined by the Food and Drug Administration (FDA) as one that affects fewer than 200,000 Americans. The FDA has an Office of Orphan Products Development (OOPD), which offers grants to researchers to develop these products.
References in periodicals archive ?
Several years ago, Congress passed a follow-up to the Orphan Drug Act.
Given all of the ways that orphan status can be granted, it is clear that the Orphan Drug Act has led to higher-than-necessary prices for many "non-orphan" drugs.
As Abbey retires and the rare disease community celebrates the 25th anniversary in 2008 of NORD and of the Orphan Drug Act, patients and families around the world will have benefited from the work of this unassuming woman who still, when being introduced for the first time to a roomful of people, often says those familiar words: "I'm Abbey Meyers, and I'm a housewife from Connecticut.
The Food and Drug Administration (FDA), which is charged with administration of the Orphan Drug Act, provides orphan drug designation when the targeted disease afflicts 200,00 or fewer Americans and no satisfactory therapy exists to combat the disease.
The Orphan Drug Act created financial incentives to entice drug companies into developing new treatments for these disorders.
The Orphan Drug Act was designed to bring resources to bear on conditions and disease states which might not otherwise attract the efforts of private sector research," said Dr.
The United States Orphan Drug Act of 1983 was created to promote and support the development of new drug therapies for diseases that affect fewer than 200,000 people in the United States.
The Orphan Drug Act provides Orphan Pharmaceuticals with 7-year exclusive marketing rights as the first sponsor to obtain marketing approval for the drug.
The 1983 Orphan Drug Act (with amendments passed by Congress in 1984, 1985, and 1988) includes various incentives that have stimulated interest in the development of orphan drug and biologic products.
It was not until after Congress passed the Orphan Drug Act in 1983 that many new treatments and therapies were developed for a variety of rare disorders.
The Orphan Drug Act of 1983 "provides financial incentives that have motivated pharmaceutical manufacturers to develop new treatments for rare disorders.
Much progress has been made since the passage of the Orphan Drug Act of 1983, but many patients with rare diseases remain without effective treatment options," said Sanj K.