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The granting of the orphan drug status is designed to encourage the development of drugs which are necessary but would be prohibitively expensive/un-profitable to develop under normal circumstances.
In the United States, an orphan drug is any drug developed under the Orphan Drug Act of January 1983 ("ODA"), a federal law concerning rare diseases ("orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States or low prevalence is taken as prevalence of less than 5 per 10,000 in the community. This has been adopted as a subclause of the Food and Drug Administration (FDA) regulations. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions and marketing exclusivity (a "monopoly") on that drug for an extended time (seven years post-approval). The concept behind the ODA is that the longer period of exclusivity will encourage more companies to invest money in research. Under the act many drugs have been developed, including drugs to treat glioma, multiple myeloma, cystic fibrosis, and snake venom. In the US, from January 1983 to June 2004, a total of 1,129 different orphan drug designations have been granted by the Office of Orphan Products Development (OOPD) and 249 orphan drugs have received marketing authorization in the US. In contrast, the decade prior to 1983 saw fewer than ten such products come to market. Oral medication A medication is any drug taken to cure or reduce the symptoms of an illness or ongoing medical condition. ...
Federal law is the body of law created by the federal government of a nation. ...
A rare disease (sometimes known as an orphan disease) has such a low prevalence in a population that a doctor in a busy general practice would not expect to see more than one case a year. ...
FDA logo The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. ...
Medical research (or experimental medicine) is basic research and applied research conducted to aid the body of knowledge in the field of medicine. ...
Look up Therapy in Wiktionary, the free dictionary. ...
In economics, a monopoly (from the Latin word monopolium - Greek language monos, one + polein, to sell) is defined as a persistent market situation where there is only one provider of a product or service. ...
A glioma is a type of primary central nervous system (CNS) tumor that arises from glial cells. ...
Multiple myeloma (also known as MM, myeloma, plasma cell myeloma, or as Kahlers disease after Otto Kahler) is a type of cancer of plasma cells which are immune system cells in bone marrow that produce antibodies. ...
// Snake venom is a highly modified saliva that is produced by special glands. ...
A similar status exists in the European Union, administered by the Committee on Orphan Medicinal Products of the European Medicines Agency. Agency of the European Union Location: London, United Kingdom Formation: - Signed - Established 1995 Superseding pillar: European Communities Director: Thomas Lönngren Website: emea. ...
The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ...
In 2003, the leading orphan drug by worldwide sales revenue was Amgen’s Erythropoietin (Epogen®), with sales of $2.4bn. Amgen Inc. ...
Erythropoietin (IPA pronunciation: , alternative pronunciations: ) or EPO is a glycoprotein hormone that is a cytokine for erythrocyte (red blood cell) precursors in the bone marrow. ...
Development of orphan drugs Since few markets would naturally exist to create these goods, as the costs of developing, researching and producing this drug would likely exceed any revenues, government intervention is required, usually to establish such a market or to produce the goods itself. Critics of the free market often cite this as a market failure in free market economic systems. Free market advocates often respond that without government intervention development costs would be considerably lower. Look up Market in Wiktionary, the free dictionary. ...
This article or section does not adequately cite its references or sources. ...
A free market is an idealized market, where all economic decisions and actions by individuals regarding transfer of money, goods, and services are voluntary, and are therefore devoid of coercion and theft (some definitions of coercion are inclusive of theft). Colloquially and loosely, a free market economy is an economy...
Face-to-face trading interactions on the New York Stock Exchange trading floor. ...
The intervention by government can take a variety of forms:
- Tax benefits to companies who produce or research these drugs
- Granting of additional rights above and beyond those granted by the regular patent laws.
- Subsidizing and funding clinical research by universities and industry sponsors to develop medical products (including drugs, biological products, devices, and medical foods) for rare diseases.
- Creating a government-run company to research and produce drugs (see Crown corporation for an example of this type of solution).
A tax is a financial charge or other levy imposed on an individual or a legal entity by a state or a functional equivalent of a state (for example, tribes, secessionist movements or revolutionary movements). ...
A patent is a set of exclusive rights granted by a state to a patentee (the inventor or assignee) for a fixed period of time in exchange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which...
A university is an institution of higher education and of research, which grants academic degrees. ...
In Commonwealth countries a Crown corporation is a state-controlled company or enterprise (a public corporation). ...
See also A pharmaceutical company, or drug company, is a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. ...
In European Union member countries, a supplementary protection certificate (SPC) is a sui generis, patent-like, intellectual property right. ...
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