Pursuant to the Orphan Drug Designation program, the FDA provides incentives for the development of products that will diagnose or treat rare diseases. Orphan drug status qualifies a drug sponsor to receive tax credits for clinical testing of the product and other marketing benefits. Otherwise, because it is intended to treat a rare disease, the development of the drug might not be profitable and such rare diseases may never be treated.

To qualify for orphan drug status under FDA regulations, the drug or biologic product must be intended to treat or diagnose a rare disease or condition affecting fewer than 200,000 people per year in the United States. 21 C.F.R. part 316. Additionally, an application must be submitted by the sponsor, and thereafter approved by, the FDA Office of Orphan Products Development.

If you have any questions about the Orphan Drug Designation program or FDA’s regulations of drugs, please contact us at contact@sglawfl.com.

Pursuant to the Orphan Drug Act of 1983, the FDA is responsible for the development and implementation of the orphan designation process. Through this process, drug sponsors are able to more easily obtain approval, while receiving certain tax benefits. Because orphan products are meant to treat those with very rare illnesses, these incentives were put in place to prompt drug and device sponsors in developing products that otherwise would be unprofitable to pursue. To illustrate how rare such a condition must be in order to qualify for orphan designation, Type 1 Gaucher disease is believed to afflict approximately 6,000 people in the United States. In order to obtain orphan drug status, FDA regulations require that the disease or condition for which the drug is intended to treat affects fewer than 200,000 persons per year in the United States. 21 C.F.R. part 316. For more information about obtaining an orphan designation, please contact us at contact@sglawfl.com.