MSU HRPP Manual Section 7-4

7-4, Charging for Investigational Drugs

Charging by the sponsor for an investigational drug under an Investigational New Drug (IND) is not permitted without prior written authorization from the U.S. Food and Drug Administration (FDA) in compliance with 21 CFR 312.8. This includes investigational use of a sponsor’s approved drug under an IND. If the sponsor is proposing to charge for the investigational drug, the prior written authorization from the FDA must be submitted to the Institutional Review Board (IRB) as part of the initial IRB application. If the FDA withdraws authorization to charge for the investigational drug, the principal investigator must notify the IRB immediately and submit a revision to modify the IRB approved protocol.

Sponsors who obtain an approved drug from another entity not affiliated with the sponsor for use as part of the clinical trial evaluation (e.g. in a clinical trial of a new use of the approved drug, for use of the approved drug as an active control) are not subject to the requirements in 21 CFR 312.8 and prior written authorization from the FDA is not required. 21 CFR 312.8(a)(1).

The requirements under 312.8 also do not apply to clinical investigations exempt from IND requirements under 312.2(b).

For an investigational device, charging subjects or investigators a price larger than necessary to recover costs of manufacture, research, development, and handling is not permitted. 21 CFR 812.7(b). If a sponsor requests and receives approval for a waiver of 21 CFR 812.7(b), such approval should be provided to the IRB. For purposes of assisting the Centers for Medicare and Medicaid Services (CMS) in determining Medicare coverage, the FDA places all approved IDEs into one of two categories – Category A (experimental) or Category B (non-experimental). Medicare may cover certain items/services in Food and Drug Administration (FDA)-approved IDE trials. For trials approved by the FDA before January 1, 2015, the Medicare Administrative Contractors (MACs) approve IDE studies for coverage. For trials approved by the FDA after January 1, 2015, a list of approved studies may be found at: http://www.cms.gov/Medicare/Coverage/IDE/index.html

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 7-22-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 12-11-2015.

Related HRPP Manual Sections

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