The New Science of Abuse-Deterrence Assessment of Pharmaceutical Products; FDA Proposed Guidance and Category 1 Laboratory Studies

Abstract

The problem of prescription drug abuse in the United States began more than 100 years ago and became epidemic in the last decade producing many tragic consequences with incredible societal costs. Drug overdoses have doubled over the last 10 years and now surpass deaths from motor vehicle accidents (DHHS, 2013). Congress reacted to this ongoing tragedy in 2012 by mandating the Food and Drug Administration (FDA) promulgate guidelines for the development of abuse-deterrent formulations (ADFs) for prescription opioid medications as one of the approaches to reducing this problem.The FDA responded in 2013 by issuing a draft guidance to industry for assessment of ADFs (FDA, 2013). The 2013 guidance expanded initial guidance proposed in 2010 (FDA, 2010).FDA is expected to issue final guidance for industry in the latter part of 2014.

The role of the pharmaceutical industry in the treatment of mental health disorders.

“…In response to such concerns, the FDA has required risk management programs and intensive postmarketing surveillance, including prescription drug monitoring, to more quickly and accurately detect problems (Dart, 2009;Dasgupta & Schnoll, 2009). The FDA has also incentivized the development of less abusable analgesic products by the pharmaceutical industry, including abuse deterrent formulations (Cone, Buchhalter, Henningfield, & Schnoll, 2014). Future efforts to offset the risks associated with prescription opioid abuse and dependence include expanded access to treatment on demand and medication-assisted therapies for opioid addiction (Volkow & Collins, 2017).…”