Prior to 1999, 505(b)(2) applications were rarely used and little understood. Since then, 505(b)(2) submissions have skyrocketed and now comprise 50% or more of all New Drug Applications filed with the Food and Drug Administration (FDA) each year.
The reason for this increasing popularity is clear: 505(b)(2) applications provide a streamlined development and approval process for innovative drug products based on known active ingredients. They are thus particularly attractive to companies developing improved versions of existing drugs, such as new dosage forms, new dosing intervals, new indications, and even new active ingredients.
Despite their growing popularity, 505(b)(2) applications still are often misunderstood, particularly their risks. For example, many sponsors are surprised to learn that 505(b)(2) applications can be used for New Chemical Entities (NCE); are eligible for NCE exclusivity; can be rated as therapeutically equivalent to a listed drug; and can be refused for filing if an Abbreviated New Drug Application (ANDA) could be filed instead. Moreover, many companies are shocked to discover that 505(b)(2) applications can be blocked by the exclusivity of a newly approved product that they did not know about or rely upon for approval (so-called “submarine exclusivity”).
Scott Lassman has been helping companies navigate the opportunities and risks presented by 505(b)(2) applications his entire career. One of his first projects as an FDA attorney – more than 25 years ago – involved the standards for choosing an appropriate “listed drug” for 505(b)(2) applications. Later, he helped successfully challenge the FDA approval of an NDA on the grounds that it was, in fact, a 505(b)(2) application that did not comply with required patent certification requirements. This decision prompted FDA to issue its infamous 1999 draft guidance on 505(b)(2) applications and to standardize its NDA review process to distinguish between 505(b)(2) applications and full NDAs. More recently, Scott has helped numerous companies implement legal strategies to avoid being blocked by submarine exclusivity or to mitigate the effects of such exclusivity.