Additional incentives of the ODA include the following:
- Tax credits for research conducted which can cover up to a maximum of 50% of total development costs
- Drug developers can apply for exclusive marketing rights for the drug aside from its primary approved use
- Orphan drugs are not subject to drug approval application fees and annual FDA product fees
The most lucrative of orphan drugs according to worldwide sales was Amgen’s Erythropoietin (Epogen), which generated a total of $2.4 billion in 2003.
Orphan drugs must adhere to the same standards are regularly formulated drugs, meeting the established criteria of stability, safety, and efficacy. The only substantive differences lie in the gathering of data and the attendant statistical variance.
Government intervention (and thereby influence) is a natural condition of the orphan drug industry, which relies heavily on federal dollars to execute drug development. This policy has over the years generated a wealth of criticism from free market opponents who maintain that government involvement should be kept to an absolute minimum in private industry and that such involvement demonstrates a failure of the system. Advocates counter with the argument that government is necessary in the matters of drug development and safety testing, without which many drugs would have a much more difficult time coming to the market, in some instances not developing beyond the initial stages at all.