Jessica Huening

by Jessica Huening

FDA Publishes Three New Guidance Documents: A Good Move, Part 2

In part one of this series, I examined two new guidance documents released by the FDA in June related to Expanded Access. Here I will discuss the third guidance document.

Charging for Investigational Drugs Under an IND – Questions and Answers

This document provides information relating to processes and procedures for charging participants for investigational products.

The sponsor of the IND can request authorization from the FDA to charge for an investigational drug used as part of the clinical trial evaluation for the length of the trial, or expanded access for one year from the time of authorization.  Of note, the sponsor of an IND responsible to obtain FDA authorization may or may not be the same entity as the drug manufacturer.1

While the FDA is required to authorize charging participants for an investigational drug, they do not have the authority to direct how participants will be charged, though they anticipate this would be done by either directly charging the participant or through third-party payers, as available.

The guidance outlines regulatory requirements that must be satisfied to obtain authorization from the FDA to charge for investigational drugs, including sponsor obligations to demonstrate clinical benefit, essentialness of charging to the investigation, cost calculations, and that the cost of the drug would otherwise be extraordinary to the sponsor.2  The FDA acknowledges there may be difficulties in charging for investigational drugs in blinded clinical trials, as that may reveal the treatment arm, and recommends sponsors obtain advice in methods to preserve the blind in these instances as necessary from the FDA.3

Three new documents to improve research

The FDA addresses multiple points within each of these new documents and provides specific information and recommendations for researchers. On the whole, these guidance documents are informative and are likely to improve accuracy of submissions and help researchers focus on the conduct of the trial, rather than navigating administrative questions.

 

References

[1] See 21 CFR 312.8

[2] See 21 CFR 312.8(b)(1)(i) , 312.8(b)(1)(iii), 312.8(d), and 312.8(a)(3).  For a clinical trial, sponsors may only recover the direct costs of making the drug available to participants (21 CFR 312.8(d)(1)). Note, FDA authorization is not required to charge for the costs associated with drug delivery, including formulation, packaging, instrumentation, monitoring, disposables, setup, and nursing care.  For expanded access, sponsors may only recover the direct costs of making the drug available to the patient (21 CFR 312.8(d)), as well as costs of recovery and fees to third parties for administering an intermediate-size patient population in an expanded access IND or protocol or treatment IND or protocol.

[3] FDA recommends sponsors contact the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or from the review office in the Center for Biologics Evaluation and Research (CBER) for consultation on how to preserve the blind based upon the specific protocol facts. The appropriate CDER OND review divisions can be found on the following website: http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm429610.htm.

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