FDA Submissions

FDA announced a request for information in April 2014 entitled “Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics; Request for Comments; Establishment of a Public Docket.” [ref] This request follows up on FDA’s long-standing view that packaging and data analysis innovations are on a short list of safety interventions that may reduce the crisis of prescription drug abuse. [ref]

The links below allow users to download separate Vatex submissions to the Docket that focus on a single topic.

Title (click to download) Subject
Access Barriers to Medication Because Divert-X seeks to analyze unfettered medication-use behaviors exhibited by individuals, it is the only anti-diversion and anti-misuse system known that does not limit patient access to prescribed medications.
Care Access Patient access to Controlled Substances is severely limited because provider-patient trust has been lost and must be rebuilt.
Effectiveness and Acceptability The behavioral and economics literature are the genesis of the approach: Vatex leverages established behavioral science to reduce diversion and misuse.
Hardware Design Divert-X hardware is specifically engineered for its anti-diversion and anti-misuse tasks, but it will clearly be used in other therapeutic areas with drug-safety issues.
Industry Survey The competitive environment for technology-related approaches to combating opiate misuse is relatively un-populated. No contemporary approach has been meaningfully successful.
Management Survey Helping prescribers monitor for signs of abuse or diversion by facilitating effective patient management and follow-up is the core function of the Divert-X System. It provides actionable real-time information to cause discovery and integrate follow-up.
Patient Confidentiality Vatex-managed systems cannot identify patients because the systems never receive and thus cannot contain personally identifiable information.
Payer Incentives Innovative packaging that reduces opioid misuse can generate significant economic benefit by reducing the excess medical costs consequential to abuse and fraud. Outcomes improving financial returns for private and public healthcare payers will drive implementation of an evidence-based drug safety system.
Preventing Accidental Use Blister-based dispensing of Controlled Substances via Divert-X is safer than traditional bottle-based dispensing.
Safe Disposal Because the Divert-X System is a drug-safety system that establishes a closed loop of distribution that begins and ends at the pharmacy, strong incentives can be employed to cause the return of unused medications for destruction soon after dispensing.
System Incentives and Workflow Issues It is critical that packaging and medication management systems (a) are agnostic to dose, dosage form, and manufacturer; (b) do not force pharmacies to alter their supply chains and preferred vendor networks; and (c) need not be adopted by pharmaceutical manufacturers. Only in-pharmacy assembly can deliver a broad impact on the crisis.