Charging for 
Investigational Drugs 
Under an IND 
Questions and Answers 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Office of Clinical Policy (OCLiP) 
Oncology Center of Excellence (OCE) 
 
 
February 2024 
Procedural 
Revision 1 
53685874fnlrv1.docx   
Charging for 
Investigational Drugs 
Under an IND  
Questions and Answers 
 
 Guidance for Industry 
 
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Food and Drug Administration 
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https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances     
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Office of Clinical Policy (OCLiP) 
Oncology Center of Excellence (OCE) 
 
February 2024 
Procedural 
Revision 1
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  QUESTIONS AND ANSWERS ....................................................................................... 3 
A.  General Questions Related to Charging for Clinical Trials and Expanded Access Use.......... 3 
B.  Charging in Clinical Trials ........................................................................................................... 4 
C.  Charging for Expanded Access Use ............................................................................................. 7 
D.  Cost Recovery Calculations .......................................................................................................... 8 
  Contains Nonbinding Recommendations 
Charging for Investigational Drugs Under an IND  
Questions and Answers 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page. 
 
 
 
 
I.  INTRODUCTION  
 
This guidance provides information for industry, researchers, physicians, institutional review 
boards, and patients about the implementation of FDAs regulations on charging for 
investigational drugs2 under an investigational new drug application (IND) for the purpose of 
either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect 
on October 13, 2009.3  Since 2009, FDA has received a number of questions concerning its 
implementation of the charging regulation.  As a result, FDA issued the guidance for industry 
Charging for Investigational Drugs Under IND  Questions and Answers (June 2016; revised 
draft August 2022) providing recommendations in a question-and-answer format, addressing the 
most frequently asked questions.   
 
This guidance finalizes the revised draft guidance issued in August 2022 and replaces the 2016 
guidance.  Significant changes to the 2016 version include additional recommendations related to 
(1) the need for submission of a statement by an independent certified public accountant under 
certain circumstances and (2) distribution of the manufacturing, administrative, or monitoring 
costs from the first year over the expected duration of the expanded access IND or protocol.   
 
 
1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research 
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER), the Office of Clinical Policy 
(OCLiP), and the Oncology Center of Excellence (OCE) and in consultation with the Center for Devices and 
Radiological Health (CDRH) at the Food and Drug Administration.   
 
2 In this guidance, the terms investigational new drugs, investigational drugs, drugs, and drug products refer to both 
human drugs and biological drug products regulated by CDER or CBER. 
 
3 Federal Register of August 13, 2009 (74 FR 40872). 
 
  1  Contains Nonbinding Recommendations 
In separate guidance documents, FDA provides answers to questions concerning regulations on 
expanded access to investigational drugs for treatment use (21 CFR part 312, subpart I)4 and 
discusses Form FDA 3926 (Individual Patient Expanded Access:  Investigational New Drug 
Application (IND)) and the process for submitting expanded access requests for individual 
patient INDs.5, 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND 
 
For many years, FDA authorized charging for an investigational drug under a regulation that was 
published in 1987 (the 1987 charging rule) (52 FR 19466, May 22, 1987).  In 2009, FDA revised 
its 1987 charging rule for three principal reasons:  (1) to take into account circumstances 
concerning charging for investigational drugs in a clinical trial that were not anticipated when the 
rule was written; (2) to set forth criteria for charging for investigational drugs made available 
under all categories of expanded access described in the expanded access regulations that were 
also revised in 2009; and (3) to specify the types of costs that can be recovered when charging 
for an investigational drug under an IND. 
 
The revised charging regulation provides the following:  
 
  General criteria for authorizing charging for an investigational drug ( 312.8(a))  
 
  Criteria for charging for an investigational drug in a clinical trial ( 312.8(b))  
 
  Criteria for charging for an investigational drug for an expanded access use under part 
312, subpart I ( 312.8(c))  
 
  Criteria for determining what costs can be recovered when charging for an investigational 
drug ( 312.8(d))  
 
 
4 See the draft guidance for industry Expanded Access to Investigational Drugs for Treatment Use:  Questions and 
Answers (November 2022).  When final, this guidance will represent FDAs current thinking on this topic.  We 
update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
 
5 See the guidance for industry Individual Patient Expanded Access Applications:  Form FDA 3926 (June 2016; 
updated October 2017) for the Agencys current thinking on this topic. 
 
  2  Contains Nonbinding Recommendations 
The questions and answers in this guidance are organized as follows:  (A) General Questions 
Related to Charging for Clinical Trials and Expanded Access Use, (B) Charging in Clinical 
Trials, (C) Charging for Expanded Access Use, and (D) Cost Recovery Calculations.  
 
III.  QUESTIONS AND ANSWERS 
 
A.  General Questions Related to Charging for Clinical Trials and Expanded 
Access Use 
 
Q1.   How much time does FDA have to review and respond to a sponsors request to 
charge for an investigational drug?  
 
The provision in  312.8 does not specify a time frame for FDA to respond to a request to charge 
for an investigational drug.  However, FDA intends to respond to charging requests within 30 
days of receipt when possible. 
 
Q2.  Under 21 CFR 312.8, who requests authorization from FDA to charge for an 
investigational drug for use under an IND?  
 
Section 312.8 permits only the sponsor of the IND to request FDAs authorization to charge for 
an investigational drug for use under the IND ( 312.8(a)).  Often the manufacturer of the 
investigational drug is the sponsor of the IND under which clinical studies of the investigational 
drug are conducted or under which the investigational drug is provided for treatment use under 
expanded access.  However, this is not always the case.  When the sponsor of an IND is a person 
or entity other than the manufacturer of the investigational drug (e.g., a physician), the IND 
sponsor, and not the drug manufacturer, must obtain FDAs prior written authorization to charge 
patients for the investigational drug under that IND ( 312.8(a)(3)).  See Q8 and Q9 for further 
information on charging for approved drugs for investigational use.6 
 
Q3.   Once FDA authorizes a request to charge, whom may the sponsor charge?  
 
Although FDA determines whether a sponsor may charge for an investigational drug used in a 
clinical trial or for expanded access, FDA does not decide how that charging is to be carried out.  
FDA anticipates that the sponsor would ordinarily charge a patient directly or would charge a 
third-party payor if reimbursement is available.  FDA notes that its authorities do not extend to 
reimbursement policy or reimbursement decisions for investigational drugs for which FDA has 
authorized charging, including those made by entities such as third-party payors.  For questions 
pertaining to third-party payor reimbursement, the third-party payor should be consulted.  FDA 
advises sponsors to ensure that charging for drugs in clinical trials or expanded access use does 
not create barriers to access that may exacerbate disparities in clinical trial participants or 
expanded access patients.  If participants in a clinical trial or patients being treated under 
expanded access will be charged for the investigational drug, this information must be disclosed 
 
6 In this guidance, the term approved drugs refers to drugs approved by FDA. 
 
  3  Contains Nonbinding Recommendations 
( 50.25(b)(3)) in the informed consent document (or a written summary if a short form7 is 
used).   
 
B.  Charging in Clinical Trials 
 
Q4.  When a sponsor uses its own investigational drug in a clinical trial, what 
requirements must the sponsor satisfy to charge for the drug? 
 
When a sponsor is using its own investigational drug, including an investigational use of its 
approved drug, in a clinical trial, a sponsor must do all the following to obtain authorization to 
charge for the drug:  
 
  Provide evidence to FDA that the drug has a potential clinical benefit that, if 
demonstrated in clinical investigations, would provide a significant advantage over 
available products in the diagnosis, treatment, mitigation, or prevention of a disease or 
condition ( 312.8(b)(1)(i)).  
 
  Demonstrate that the data to be obtained from the clinical trial would be essential to 
establishing that the drug is effective or safe for the purpose of obtaining initial approval 
or would support a significant change in the labeling of an approved drug (e.g., a new 
indication, inclusion of comparative safety information) ( 312.8(b)(1)(ii)). 
 
  Demonstrate that the clinical trial could not be conducted without charging because the 
cost of the drug is extraordinary to the sponsor ( 312.8(b)(1)(iii)) (see also Q5 regarding 
extraordinary cost). 
 
  Provide documentation to support its calculation for cost recovery, to the extent 
applicable, to show that the calculation is consistent with the requirements of  
 312.8(d)(1).  The documentation must be accompanied by a statement that an 
independent certified public accountant has reviewed and approved the calculation    
( 312.8(d)(3)). 
 
Sponsors must meet all these requirements and must obtain written authorization from FDA to 
charge before they begin to charge for an investigational drug ( 312.8(a)(3)).  
 
Q5.  What constitutes extraordinary cost?  
 
As noted in the answer to Q4,  312.8(b)(1)(iii) requires that the sponsor demonstrate that it 
could not conduct the clinical trial without charging for the investigational drug because the cost 
of the drug is extraordinary to the sponsor.  The cost of a drug may be considered extraordinary 
to a sponsor because of manufacturing complexity, scarcity of a natural resource, the large 
quantity of the drug needed (e.g., based on the size or duration of the trial), or some combination 
 
7 See the guidance for institutional review boards, clinical investigators, and sponsors Informed Consent (August 
2023) for the Agencys current thinking on this topic. 
  
  4  Contains Nonbinding Recommendations 
of these or other extraordinary circumstances (e.g., resources available to a sponsor)    
( 312.8(b)(1)(iii)). 
 
Q6.  Does FDA consider the financial resources available to a sponsor when determining 
whether the cost of providing its investigational drug in a clinical trial is 
extraordinary?  
 
Yes.  The provision in  312.8(b)(1)(iii) describes the reasons that the cost of a drug might be 
extraordinary to the sponsor, including the resources available to a sponsor.  For example, a cost 
that is considered extraordinary to a small start-up company may not be considered extraordinary 
to a large, established company. 
 
Q7.  What is an independent certified public accountant?  
 
An independent certified public accountant should be a certified public accountant who is 
qualified to make the required determinations for charging and not an employee of the company 
or institution seeking to charge for an investigational drug.  
 
Q8.  When a company is the sponsor of a clinical trial evaluating an unapproved use of 
its approved drug, is the company required to obtain authorization to charge for its 
drug?  
 
Yes.  In accordance with  312.8(b)(1), a sponsor of a clinical trial must obtain authorization to 
charge for its own drug, including investigational uses of its approved drug.  The sponsor can 
recover only the cost allowed under the regulations in  312.8(d)(1)that is, the direct cost of 
providing the drug for the investigational use for which FDA has authorized cost recovery.  The 
direct cost of providing the drug may not necessarily be the same as the market price of the 
approved product used for an approved indication (also see Q16 regarding direct cost). 
 
Q9.  If a sponsor (e.g., a physician-researcher who is a sponsor-investigator) purchases 
an approved drug from the company that markets the drug or from another 
commercial distribution entity (e.g., a pharmacy or a wholesaler) for use in a clinical 
trial, is the sponsor required to obtain authorization from FDA to charge for the 
approved drug?   
 
No.  If a sponsor is not the company that markets the approved drug and the sponsor must 
purchase the approved drug 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, or as 
concomitant therapy) the sponsor is not required to obtain FDA authorization to charge for the 
approved drug (see  312.8(a)(1)).  
 
Q10.  If a sponsors own approved drug is used as concomitant therapy for an approved 
use during a clinical trial intended to evaluate another drug, is the sponsor required 
to obtain authorization to charge for the drug used as concomitant therapy?  
 
  5  Contains Nonbinding Recommendations 
No.  In many clinical trials, approved drugs are used as concomitant therapy for subjects during 
the trials but are not part of the clinical trial evaluation.  For example: 
 
  Patients may be required by a protocol to take certain approved drugs as concomitant 
therapy before or during the trial (e.g., patients may receive antihistamines for immune 
response concerns in a clinical trial to study a recombinant protein, in order to mitigate 
potential risks of participation in the trial; or all patients may receive concomitant therapy 
before randomization to either the investigational drug or placebo).  
 
  Patients may be permitted by the protocol to continue taking certain approved drugs as 
concomitant therapy during the trial because such drugs are not likely to interact with the 
study drug or drugs or otherwise confound the results of the trial (e.g., pain medications 
for patients in a clinical trial to study a drug intended to treat cancer) or because 
discontinuing the drug might adversely affect the patient.  
 
In accordance with  312.8(b)(1), a sponsor must obtain prior authorization from FDA to charge 
for its investigational drugs, including investigational uses of its approved drugs.  However, FDA 
regulations do not require a sponsor to obtain prior authorization to charge for its own approved 
drug when that drug is used as concomitant therapy for an approved use and is not part of the 
clinical trial evaluation (i.e., the approved drug itself is not being evaluated for an investigational 
use). 
 
Q11.  Can a sponsor charge for its investigational drug in a blinded, controlled clinical 
trial without compromising the blind and, therefore, the integrity of the clinical data 
generated from the trial? 
  
FDA recognizes that charging for an investigational drug in a clinical trial may have the potential 
to compromise the blinding of study participants to which therapy they have received (e.g., in a 
situation in which participants who are in the treatment arm of the study are charged, and 
participants who are in the control arm are not charged).  When these situations arise, the sponsor 
may consult the appropriate review division in the Office of New Drugs (OND) in the Center for 
Drug Evaluation and Research (CDER) or from the appropriate review office in the Center for 
Biologics Evaluation and Research (CBER) on how to preserve the blind, based on the specifics 
of the given situation.   
 
  To find the appropriate CDER OND review division, see https://www.fda.gov/news-
events/expanded-access/fdas-expanded-access-contact-information.   
 
  For contact information for CBER, see https://www.fda.gov/about-fda/center-biologics-
evaluation-and-research-cber/cber-offices-divisions. 
 
  6  Contains Nonbinding Recommendations 
Q12.  How long may a sponsor charge for an investigational drug in a clinical trial after 
FDA authorizes the charging?  
 
Charging may continue for the entire length of the clinical trial unless FDA specifies a shorter 
duration ( 312.8(b)(2)).  Refer to Q14 for information about how long a sponsor may charge for 
an investigational drug for expanded access use. 
 
C.  Charging for Expanded Access Use  
 
Q13.  What requirements must a sponsor satisfy to charge for expanded access use?8 
 
The sponsor of an expanded access IND or protocol must do all the following to obtain 
authorization to charge for the drug:  
 
  Provide reasonable assurance to FDA that charging will not interfere with drug 
development ( 312.8(c)(1)).  
 
  Provide documentation in its charging request submission to show that its calculation of 
the amount to be charged is consistent with the requirements in  312.8(d), to the extent 
applicable.  This documentation must be accompanied by a statement that an independent 
certified public accountant has reviewed and approved the calculation ( 312.8(d)(3)).  
When the amount to be charged for a drug is simply the amount charged to the expanded 
access sponsor by a third party who provides the drug to the expanded access sponsor, 
such that there is no calculation of cost made by the sponsor to which the requirement 
under  312.8(d)(3) applies, the expanded access sponsor should provide a copy of the 
receipt or invoice from the source that provided the drug to the expanded access sponsor 
to justify the amount to be charged for the drug. 
 
For expanded access under  312.320 (treatment IND or treatment protocol), the reasonable 
assurance that charging will not interfere with drug development must include (1) evidence of 
sufficient enrollment in any ongoing clinical trials needed for marketing approval to reasonably 
assure FDA that the trial or trials will be successfully completed as planned; (2) evidence of 
adequate progress in the development of the drug for marketing approval; and (3) information 
submitted under the general investigational plan specifying the drug development milestones the 
sponsor plans to meet in the next year ( 312.8(c)(2)).  
 
Sponsors of expanded access INDs and protocols must meet these requirements and obtain 
written authorization from FDA before they begin to charge for an investigational drug  
( 312.8(a)(3)).  
 
 
8 The regulations regarding expanded access to investigational drugs for treatment use are in part 312, subpart I.  As 
explained in footnote 4, FDAs draft guidance for industry Expanded Access to Investigational Drugs for Treatment 
Use:  Questions and Answers provides information on expanded access (when final, this guidance will represent the 
FDAs current thinking on this topic). 
 
  7  Contains Nonbinding Recommendations 
Q14.  How long may a sponsor charge for an investigational drug for expanded access use 
after FDA authorizes the charging?  
 
Charging for an investigational drug for expanded access use may continue for 1 year from the 
time of FDA authorization unless FDA specifies a shorter period ( 312.8(c)(4)).  FDA 
periodically reassesses whether charging is interfering with development of a drug for marketing 
and believes that the 1-year anniversary is typically a reasonable point in time to reevaluate 
charging requests.  Additionally, FDA may reauthorize charging for an investigational drug for 
expanded access use for additional periods (typically a year or shorter based on the request and 
the circumstances) under  312.8(c)(4) if reauthorization is requested by the sponsor and all 
criteria are met.  If a sponsor wishes to continue charging beyond the expiration of the existing 
authorization, FDA recommends that the sponsor submit a request to reauthorize charging at 
least 60 days prior to the expiration of the existing authorization to charge for the investigational 
drug (see Q15). 
  
Q15.  What must a sponsor do to obtain authorization to continue charging for an 
investigational drug for expanded access use beyond the duration of its existing 
charging authorization (i.e., for additional periods)?  
 
If a sponsor wishes to continue charging beyond the duration of its existing charging 
authorization, the sponsor must submit a request to FDA for reauthorization to charge for the 
investigational drug ( 312.8(c)(4)).  The request must satisfy the same requirements as the 
initial request for charging authorization (see Q13).  It is also helpful for sponsors to specify 
whether any information from the original or previous request has changed.  The sponsor must 
receive written reauthorization from FDA before it can continue to charge for the investigational 
drug beyond the period previously authorized ( 312.8(a)(3)). 
 
D.  Cost Recovery Calculations  
 
Q16.  What costs can a sponsor recover when charging for an investigational drug in a 
clinical trial?  
 
A sponsor can recover only the direct costs of making a drug available to subjects in a clinical 
trialthat is, those costs that are specifically and exclusively attributable to providing the drug 
to clinical trial subjects for which FDA has authorized cost recovery ( 312.8(d)(1)).  These 
include costs to manufacture the drug, including manufacturing at the site of drug delivery (e.g., 
raw materials, labor, non-reusable supplies and equipment used to manufacture the drug in the 
quantity needed to conduct the clinical trial for which charging has been authorized), or costs to 
acquire the drug from another source, as well as direct costs to ship and handle (e.g., store) the 
drug ( 312.8(d)(1)(i)).  
 
Q17.  What costs can a sponsor recover when charging for an investigational drug for the 
different types of expanded access use under 21 CFR part 312, subpart I? 
 
When charging for individual patient expanded access (under  312.310) to an investigational 
drug, a sponsor may recover only its direct costs associated with making the drug available to the 
  8  Contains Nonbinding Recommendations 
patient (see Q16 and  312.8(d)).  For individual patient expanded access, the sponsor may not 
charge for administrative costs associated with providing an investigational drug 
( 312.8(d)(1)(ii)). 
 
When charging for an investigational drug used in an intermediate-size patient population 
expanded access IND or protocol (under  312.315) or a treatment IND or protocol (under  
 312.320),9 in addition to the direct drug costs, a sponsor may recover (1) the cost of monitoring 
the expanded access IND or protocol, (2) the cost of complying with IND reporting 
requirements, and (3) other administrative costs directly associated with the expanded access use 
( 312.8(d)(2)).  
 
Q18.  May the sponsor of an expanded access IND or protocol recover the cost of the fees 
the sponsor pays to a third party for administering an intermediate-size patient 
population expanded access IND or protocol or a treatment IND or protocol?  
 
Yes.  FDA interprets  312.8(d)(2) as permitting the sponsor of an expanded access IND or 
protocol to recover the cost of the fees paid to a third party for administering an intermediate-size 
patient population or treatment IND or protocol, including any profit for the third party that may 
be included in the fees.  The fees paid to the third party should be included in the calculation for 
cost recovery that the sponsor provides in its request to charge.  In addition, FDA recommends 
that the sponsor disclose to the patients any relationship it may have with the third party.   
 
Q19.  Does a sponsor need FDA authorization to charge for the costs of drug delivery, 
including the costs associated with reconstitution, packaging, instrumentation, 
monitoring, disposables, setup, and nursing care?  
 
No.  The provision in  312.8(d)(1) is intended to permit a sponsor to recover the direct costs 
incurred in making a drug available.  FDA authorization is not needed to recover costs incurred 
at a clinical trial site (e.g., a hospital or clinic), including pharmacy costs (e.g., the cost to 
reconstitute a drug for infusion), nursing costs (e.g., costs associated with administering a drug 
and monitoring study subjects), equipment costs (e.g., intravenous administration sets, infusion 
pumps), and costs for study-related procedures (e.g., chemistry labs, radiographic procedures) 
because these costs do not fall within the scope of  312.8.  
 
Q20.  What information is a sponsor required to submit to support its cost calculation?  
 
Under  312.8(d)(3), to support its calculation of recoverable costs, a sponsor must provide 
documentation to show that its calculation is consistent with the requirements of  312.8(d)(1), 
describing recovery of direct costs and, if applicable, the requirements of  312.8(d)(2), 
describing certain additional costs that may be recovered for intermediate-size patient population 
 
9 Intermediate-size patient population expanded access is access to an investigational drug for use by more than one 
patient but generally fewer patients than are treated under a typical treatment IND or protocol ( 312.315). Under a 
treatment IND or treatment protocol, FDA may permit an investigational drug to be used for treatment use by a 
large (widespread) population. ( 312.320).  For additional information about these two categories of expanded 
access, see the draft guidance for industry Expanded Access to Investigational Drugs for Treatment Use:  Questions 
and Answers.    
  9  Contains Nonbinding Recommendations 
expanded access uses or treatment INDs or protocols.  This documentation must be accompanied 
by a statement that an independent certified public accountant has reviewed and approved the 
calculations ( 312.8(d)(3)). 
 
Q21.  Is a sponsor of an expanded access IND who seeks to recover the cost incurred from 
obtaining an investigational drug from another source required to include in the 
charging request submitted to FDA a statement that an independent certified public 
accountant has reviewed and approved the calculation? 
 
No.  As discussed in the response to Q13, when the amount to be charged for a drug is simply the 
amount charged to the expanded access sponsor by a third party who provides the drug to the 
expanded access sponsor, such that there is no calculation of cost made by the sponsor for an 
independent certified public accountant to approve and to which the requirement under  
 312.8(d)(3) applies, the expanded access sponsor should provide a copy of the receipt or 
invoice from the source that provided the drug to the expanded access sponsor to justify the 
amount to be charged for the drug. 
 
Q22.  Can a sponsor of an intermediate-size patient population or treatment IND or 
protocol seeking to charge for the investigational drug distribute the costs associated 
with monitoring the program for the intermediate-size patient population or 
treatment IND or protocol and other administrative startup costs over the 
expected duration of the IND or protocol, rather than in the first year of the 
treatment? 
 
Yes.  The costs associated with monitoring the program for an intermediate-size patient 
population or treatment IND and other administrative startup costs may be higher in the first year 
and may be expected to decrease in subsequent years.  If all the additional costs in the first year 
are charged to the patients who will be receiving the drug in the first year, they may have to pay 
a higher price for the drug compared to patients receiving it in subsequent years.  The sponsor 
may prefer to distribute these costs to all patients who are expected to participate in the IND or 
protocol, rather than among first-year patients only, to reduce the per-patient cost difference 
between patients treated earlier and patients treated later.   
 
Such a plan to distribute costs to patients over multiple years may be authorized.  The cost 
amortization for such a cost distribution plan should be done in accordance with standard 
accounting practices, and the calculations for cost recovery must be reviewed and approved by 
an independent certified public accountant ( 312.8(d)(3)).  Regardless of whether an 
amortization plan is included in the request and approval to charge, the charging authorization 
still expires no later than 1 year from authorization, and sponsors must still submit a request to 
reauthorize charging if they wish to continue charging after the expiration of the initial 
authorization period ( 312.8(c)(4)).  
 
Q23.  Can a sponsor of an expanded access IND or protocol seeking to charge for the 
investigational drug distribute the costs associated with manufacturing the drug
which are typically higher in the first year compared to subsequent yearsover the 
duration of the IND or protocol, rather than in the first year of the treatment? 
  10  Contains Nonbinding Recommendations 
 
Yes.  The costs of manufacturing a drug in the first year are often expected to be higher 
compared to subsequent years.  If all the additional costs of setting up the manufacturing process 
in the first year are charged to the patients who will be receiving the drug in the first year, they 
may have to pay a higher price for the drug compared to patients receiving it in subsequent years.  
The sponsor may prefer to distribute one-time costs associated with setting up the manufacturing 
process among all patients who are expected to participate in the IND or protocol, rather than 
among first-year patients only, to reduce the per-patient cost difference between patients treated 
earlier and patients treated later.   
 
Such a plan to distribute costs to patients over multiple years may be authorized.  The cost 
amortization for such a cost distribution plan should be done in accordance with standard 
accounting practices, and the calculations for cost recovery must be reviewed and approved by 
an independent certified public accountant ( 312.8(d)(3)).  Regardless of whether an 
amortization plan is included in the request and approval to charge, the charging authorization 
still expires no later than 1 year from authorization, and sponsors must still submit a request to 
reauthorize charging if they wish to continue charging after the expiration of the initial 
authorization period ( 312.8(c)(4)).  
  11