Nolan Auerbach & White addressed orphan off label drug marketing in our blog on November 10, 2015.
Orphan Drugs are used in the diagnosis, prevention and/or treatment of rare life-threatening or very serious diseases. The Orphan Drug Act (ODA) provides for orphan designation to a drug or biological product (“drug”) to treat a rare disease or condition. For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316.
In a report in the American Journal of Clinical Oncology, Johns Hopkins accuses pharma companies of “gaming the system” with orphan drugs, by:
“…getting orphan designations for drugs that have much wider application than the rare disease they first target, drugmakers capture millions in subsidies and tax breaks for drugs that become blockbuster and reap billions in sales. In so doing, they are potentially diverting funds from the development of some new and badly needed drugs.”
More information for whistleblowers is located at the Nolan Auerbach & White website.