On January 17, 2017, just in time to evade the President’s Regulatory Freeze Memorandum, FDA announced the availability of a final guidance entitled “Assessment of Abuse Potential of Drugs.” The guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their drug product has abuse potential. Specifically, FDA’s guidance provides recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs. The guidance finalizes a draft guidance issued under the same name on January 27, 2010.
The final guidance adds more detailed discussion about key questions and decision points to consider during drug development that will likely determine the appropriate studies for sponsors and applicants to conduct to address the abuse potential of their new drug, inform appropriate labeling of the product upon its approval, and allow a thorough scientific and medical evaluation to support scheduling decisions in accordance with the Controlled Substances Act. Further, the guidance takes into consideration recently enacted legislation that altered the controlled substances scheduling process by, among other things, requiring DEA to issue an interim final rule scheduling a drug within 90 days of receipt of the later of (1) notification from FDA that a marketing application has been approved by FDA and (2) the scheduling recommendation of HHS with respect to the subject drug in the marketing application. See Improving Regulatory Transparency for New Medical Therapies Act of 2015 (Pub. L. 114-89) (2015). DEA’s interim rule now establishes “the effective date of approval for the drug product.” 21 USC 355(x); FDA, 82 Fed. Reg. 5582.
In summary, FDA’s guidance provides
- Definitions of drug abuse, abuse potential, and other related terminology;
- A discussion as to which studies FDA recommends be included in an abuse potential assessment for a CNS-active drug in order to satisfy the requirements of 21 CFR 314.50(d)(5)(vii), with recommendations for the battery of relevant studies that may be conducted in a logical sequence that builds on new data acquired during drug development;
- A discussion as to when to conduct the recommended abuse-related studies, and how to appropriately design them;
- General administrative recommendations for obtaining FDA advice, consistent with CDER’s 21st Century review policies and draft guidance for industry, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products;
- A discussion regarding the abuse-related components of a NDA, including a proposal (with justification) addressing whether the drug product should be scheduled under the CSA, and if so, a proposed schedule (see 21 CFR 314.50(d)(5)(vii)). A scheduling proposal may request any of the following: to control a substance in a particular schedule, to decontrol a substance, to transfer a substance to a new schedule, or to not control the substance.
If you have questions about this guidance or how it may apply to your products, please contact the authors of this blog post.