The Orphan Drug Act
The term orphan drug refers to a product that treats a rare disease affecting fewer than 200,000 Americans. Orphan drugs help the companies that manufacture them, under the Orphan drug act. Under the act a small company can pick up a product that would be worth anywhere from $5 million to $20 million a year. The orphan drug act has helped in the development of products to treat drug addiction, leprosy, hemophilia, and rare cancers, as well as diseases most people have never heard of, such as cryptosporidiosis (an infection caused by a protozoan parasite found in animals' intestines that causes diarrhea, fever, weight loss, and lymph node enlargement) and neurocysticerosis. In the past the FDA under the drug act has approved few years ' 41 orphan drugs. One of the premier examples of how well the Orphan Drug Act can work came with the approval of the drug PEG-ADA (adenosine deaminase and enzyme the body usually produces on its own). "This was a breakthrough" FDA's Haffner said of PEGnology, the enzyme replacement process developed by Enzon. "If it works the way it's thought it will, this technology will change the way we can provide drugs to the patients".
The history of the Orphan Drug Act
FDA set up the offices of Orphan Product Development in 1982 to focus on drugs, medical devices, foods for medical purposes, and biologics such as immune globulin for rare disorders. President Reagan signed the Orphan Drug Act into law on JAN. 3 1983. It guarantees the developer of an orphan drug seven years of market exclusivity and 50 percent tax credit for certain clinical research expenses. Imagine Pepsi or Coke having a monopoly on each other's soft drink, that would be the equivalent on that. Initially, the act app...
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...re fewer than 200,000 people.
9. A statement to whether the sponsor submitting the request is the real party in interest of the development and the intended or actual production and sales of the product.
Bibliography:
Sources
The U.S. FDA web site
Docket NO. 85n-0483 Orphan Drug Regulations.
Report by:
Emery J. Sturniole
OOPD
Program Overview
Alliance of Genetic Support Groups
1-800-336-GENE
Rare Disorder Network of General Clinical Research Centers
1-800-428-6626
National Organization for Rare Disorders
1-800-999-NORD
Excerpts of Statues Relevant to the Development and Approval of Drugs, Medical Devices, & Medical Foods for Rare Diseases or Conditions.
Orphan Drug Amendments of 1992
Orphan Disease Update newsletter volume 7 and 10 ed. 3
National Organization for Rare Disorders
Rare Disease Database Report
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government set forth the Food and Drugs Act of 1906 in response which regulated and
Melvin, Justice. "In The Supreme Court Of British Columbia." Issues In Law & Medicine 9.3 (1993): 309. Academic Search Complete. Web. 16 Nov. 2013.
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FDA, so many people were harmed. Even other countries versions of the FDA approved it which
"Regulatory Information." Federal Food and Drugs Act of 1906. U.S. Food and Drug Administration, 20 May 2009. Web. 14 Apr. 2014. .
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20 Feb. 2014. Nardo, Don. A. Biomedical Ethics.
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Boston University School of Law; American Journal of Law and Medicine.
WHO, W. H. (2008). Tradtional Medicine. available at http://www.who.int/mediacentre/factsheets/fs134/en/ retrieved on 9-11-11 at 10:30 pm.