Single Source Procurement: Expanded Access Investigational New Drugs Studies

Pursuant to New York State Finance Law § 163.10(b), The New York State Department of Health is presenting the following summary of relevant circumstances, and material and substantial reasons why a competitive procurement was not feasible.

The Department of Health requested and received approval to increase the budget of Contract #C030180 to include new costs for EKGs and menstrual diary checks that are now requested by the FDA for sites studying Epidiolex.

The Governor of the State of New York has announced his support for clinical research that would investigate the use of cannabidiol in children and young adults with medication-resistant epilepsies.

The Department is collaborating with the New York University School of Medicine that have the necessary experience, expertise and infrastructure to conduct clinical studies in accordance with accepted medical and regulatory standards. The NYS DOH has been collaborating with GW Pharmaceuticals PLC (GW), the developer of the investigational cannabidiol medication, Epidiolex®, which is currently being used to treat such children and young adults in physician-sponsored Investigational New Drug (IND) programs around the United States, and will be used in the studies conducted under these contracts.

The goal of these studies is to support clinical research that would investigate the use of cannabidiol in the treatment of children and young adults with medication-resistant epilepsies. The clinical study protocols have basic aims of safety (adverse side effects, EKG changes, menstrual cycle changes, blood work), and AED (antiepileptic drug) interaction with cannabidiol.

Procurement / Program Name	Expanded Access Investigational New Drug Studies
Contractor Name(s)	New York University School of Medicine
Contract Period	12/1/2014 – 11/30/16
Contract Number(s)	C030180