The Orphan Drug ActThe term orphan drug refers to a product that treats a rare disease affecting fewer than 200,000 Americans. Orphan drugs help the companies that make them, under the Orphan Drug Act. Under the law, a small business can acquire a product that would be worth between $5 million and $20 million per year. The Orphan Drug Act has helped develop products to treat drug addiction, leprosy, hemophilia, and rare cancers, as well as diseases most people have never heard of, like cryptosporidiosis (a infection caused by a protozoan parasite present in animals). intestines which cause diarrhea, fever, weight loss and enlarged lymph nodes) and neurocysticerosis. In the past, the FDA, under the Drug Act, approved 41 orphan drugs a few years ago. One of the best examples of the effectiveness of the Orphan Drug Act came with the approval of the drug PEG-ADA (adenosine deaminase and enzyme that the body usually produces itself). “It was a major breakthrough,” the FDA's Haffner said of PEGnology, the enzyme replacement process developed by Enzon. “If it works the way it thinks it will, this technology will change the way we can deliver medicines to patients.” The History of the Orphan Drug Act The FDA created the Orphan Product Development Offices in 1982 to focus on drugs and medical devices. , foods for medical purposes and biological products such as immunoglobulins for rare diseases. President Reagan signed the Orphan Drug Act on January 1. 3 1983. It guarantees the developer of an orphan drug seven years of market exclusivity and a 50 percent tax credit for certain clinical research expenses. Imagine if Pepsi or Coca-Cola had each other's monopoly on their soft drinks, that would be the equivalent. Initially, the law concerned...... middle of paper ...... represented less than 200,000 people.9. A statement indicating whether the sponsor submitting the application is the true party interested in the development and production and anticipated or actual sales of the product.Bibliography:SourcesThe United States FDA websiteDocket NO. 85n-0483 Orphan Drug Regulations.Report prepared by: Emery J. SturnioleOOPDProgram OverviewAlliance of Genetic Support Groups1-800-336-GENERAre Disorder Network of General Clinical Research Centers1-800-428-6626National Organization for Rare Diseases1-800 -999-NORDStatue extracts Relevant for the development and approval of drugs, medical devices and medical foods for rare diseases or conditions. Orphan Drug Amendments of 1992, Orphan Disease Update, Volume 7 and 10 ed. 3National Organization for Rare Diseases Rare Disease Database Report