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 ActFDA 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 applied to only patient populations when it could be shown there was little or no hope of recovering development cost from sales in the United States. A later amendment to the act defi...
