From concept to marketing, product development presents a myriad of challenges and opportunities, especially for the sponsor of a product designated or likely to be designated a controlled substance or regulated chemical. Occasionally, a sponsor will successfully navigate the complex route of the New Drug Application (NDA) process with the FDA only to learn at the last minute that the scheduling of the product will delay its launch, possibly for months (e.g., in the case of a new molecular entity).
An early consultation with PDRC may help product developers avoid surprises like this by providing advice for clients whose product has a stimulant, depressant, or hallucinogenic effect that, by law, must be evaluated by FDA in its NDA review to determine whether DEA scheduling is warranted. Since 2011, there have been four new molecular entities referred by FDA for DEA scheduling. Because they were new chemical substances, DEA was required to perform a detailed eight-factor analysis before scheduling. This process took 342 days (range = 338-430), on average, from the time that DEA was notified by FDA and the effective date of the DEA scheduling (i.e., marketing approval). A delay of this magnitude can adversely impact a new product’s life cycle. While PDRC can do nothing to alter these requirements, an early consultation with PDRC can help drug makers plan for them.