![]() ![]() ![]() It is also worth noting that esters, salts, and other noncovalent derivatives of a given active moiety are generally considered the same drug when it comes to ODD. ![]() There must be a scientific rationale establishing a medically plausible basis for the use of the product for the rare condition.Ī key point to remember is that ODD applies to both the active moiety and the condition, but not necessarily the product formulation.Adequate documentation or prevalence data must demonstrate that the intended condition is rare.The product must be intended for use in a rare disease or condition.There are three major criteria for obtaining ODD for a drug or biological product: This act established the ODD program and has since been amended several times to add clarity and additional incentives. To incentivize pharmaceutical companies to address the unmet needs of patients with rare diseases, the Orphan Drug Act of 1983 was passed. Companies developing such products can expect to incur a financial loss, and, as a result, the pharmaceutical industry has neglected many rare diseases. Many diseases and conditions affect such small numbers of people that a drug or biological product developed to treat these patients generates relatively little return on investment for development costs. Part 1 offered an overview and side-by-side comparison of the three designations, and now in Part 2, we give a detailed explanation of ODD for rare disease drug sponsors. ORPHAN DRUG ACT SERIESThe Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. ![]()
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