When a new therapy with abuse potential is approved by the Food and Drug Administration (FDA), the sponsors may not commercially market the drug until it has been scheduled by DEA and labeled within the controlled substance schedule. FDA provides a recommended schedule to the DEA based on the extensive medical and scientific research performed on the medication during the approval process. The recommended schedule is designed to ensure patients with legitimate health needs have access to necessary medications, while making it hard for people who could abuse them to gain access to these medications. Upon receiving the FDA’s recommendation for scheduling, the DEA then undertakes its own review. Before passage of H.R. 639, this review was unpredictable and often lengthy. There was no formal deadline or requirement that a timeline for agency action be provided to patients or physicians.
Without apparent cause or justification, the time period between initial drug approval by FDA and final scheduling by DEA has been increasing over the years. Between 1997-1999 and 2009-2013, the average time between FDA approval and DEA's final scheduling increased from an average of 49.3 days to an average of 237.6 days, an almost five-fold increase. DEA has always adopted the FDA recommended schedule, and must rely on the science provided by FDA when conducting its review. Patients cannot access these new FDA-approved therapies while they are under DEA review. In addition, the sponsoring company continues to lose time on their product's data exclusivity and patents, and the uncertainty at the end of the drug approval process could lead to a decrease in innovation and investments in new epilepsy therapies. H.R. 639 will improve the transparency and consistency of the DEA review of new FDA-approved medications and bring these medications to patients faster.