Orphan drugs classification

TABLE 3.3. Comparisons of indications, approval dates, and revenues of two colony-stimulating factors approved by FDA under the Orphan Drug Classification... 

Although classification of orphan drugs may be made along several lines, no single classification has been accepted as universally acceptable. In fact, several classifications have been proposed (Spilker, 1991). This section briefly mentions the criteria on which a classification scheme could be based and describes a simple classification based on economic value combined with medical value. 

The major criteria that may be used to create a classification of orphan drugs include the following ... 

Medical value of the drug. In the author s opinion, this is the most important criterion to judge (or classify) orphan drugs. If the drug does not have, or is not expected to have, high medical value, there are very few instances where its development would make sense. A classification of medical value may be as simple as high, medium and low. 

An economic classification is one of the most relevant alternative classifications to consider, particularly for companies considering the development of orphan drugs. Five categories of drugs can be described. These are as follows. 

In 1985, another amendment to the Act made it possible for patented and patentable medicines to receive orphan drug designation (a pre-marketing classification) and orphan drug status (a post-NDA approval classification). 

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