FDA Issues Two New Guidance Documents

On June 1, FDA issued two new guidance documents: one addressing charging for investigational drug and the other discussing FDA’s categorization of investigational devices for CMS reimbursement.

The first guidance is a procedural guidance, “Charging for Investigational Drugs Under an IND“. Using a question and answer format, this guidance answers the questions most frequently asked FDA on obtaining FDA authorization to charge for investigational drug. Under 21 CFR 312.8 Sponsor of an IND must obtain FDA’s authorization in order to charge for an investigational drug for use under the IND. Sponsors do not need to seek FDA authorization to charge for an approved drug used 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) so long as the drug is obtained from an another, unaffiliated entity.

The second guidance is a draft guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions” (the “Coverage Decision” guidance) modifies the FDA’s current policy on categorizing investigational device exemption (IDE) devices. The FDAs categorization assists the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS.

The Coverage Guidance sets out the criteria the FDA intends to use to assign a device to a CMS Category A or B. The Coverage Guidance provides examples and includes a flowchart of the FDA’s decision making process. Generally, Category A devices are true “experimental” devices, those for which the initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type can be safe and effective. Category B devices will have existing evidence of safety and effectiveness for the device and/or the intended indication and use either through an existing authorization or clearance for the device or a similar device or there is sufficient non-clinical or clinical data on the device or a sufficiently similar device.