For most drugs, that FDA press release announcing approval signals the start of commercialization: the last tollgate before open marketing and sales. But products that need Drug Enforcement Administration scheduling have a second toll gate and are finding that getting DEA clearance is less deadline driven and is taking an increasingly long time.
The frustration building around post-FDA-approval marketing delays was a key theme at a March 28 Food & Drug Law Institute conference on controlled substances regulation. With two drugs currently awaiting...