Law360, New York (January 28, 2015, 12:21 PM EST) -- The Orphan Drug Act[1] was signed into law by President Ronald Reagan in January 1983. Prior to the ODA's passage, drugs specifically targeting rare diseases were generally not developed. The primary cause of this deficit was economic. Because of the smaller market size associated with rare diseases, pharmaceutical companies could not recoup the significant research and development costs for these drugs. Recognizing the significant unmet medical need, Congress crafted the ODA to provide regulatory and financial incentives for pharmaceutical companies to develop drugs targeting these rare diseases. Such drugs are termed orphan drugs.[2] The ODA, in encouraging the development of drugs to treat small patient populations, is an example of the application of democratic principles in pharmaceutical legislation....