PDUFA PILOT 
PROJECT 
 
PROPRIETARY NAME REVIEW  
 
 
CONCEPT PAPER 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
September 2008 
 
 
 
 
 
8455 FINALConcept Paper.doc   Concept Paper 
 
PDUFA PILOT PROJECT 
PROPRIETARY NAME REVIEW  
CONCEPT PAPER 
 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION..........................................................................................................................................1 
II.  BACKGROUND.............................................................................................................................................2 
A.  MEDICATION ERRORS.....................................................................................................................................2 
B.  2003 FDA PUBLIC MEETINGS ON DRUG NAMING...........................................................................................4 
C.  DECEMBER 2003 MEETING.............................................................................................................................5 
D.  JUNE 2008 MEETING.......................................................................................................................................5 
III.  PDUFA PILOT PROGRAMLOGISTICS................................................................................................6 
A.  WHAT ARE THE GENERAL LOGISTICS OF THE PILOT PROGRAM?....................................................................6 
B.  HOW WILL THE PILOT PROGRAM FUNCTION?.................................................................................................7 
C.  WHAT IF I WANT TO DEVIATE FROM THE PROCESS IN THE CONCEPT PAPER?.................................................7 
D.  WHY DO I HAVE TO MAKE TWO SUBMISSIONS?.............................................................................................8 
E.  WHAT HAPPENS TO MY SUBMISSION AND HOW WILL IT BE REVIEWED?......................................................8 
F.  WILL IND AND NDA/BLA SUBMISSIONS BE HANDLED DIFFERENTLY?........................................................9 
G.  WHAT WILL THE AGENCY REVIEW IN DETERMINING A PROPOSED NAME'S ACCEPTABILITY?.......................9 
H.  WHAT IF MY FIRST CHOICE NAME IS NOT ACCEPTABLE?..............................................................................9 
I.  WHEN AND HOW WILL THE PILOT PROGRAM BE ASSESSED?.......................................................................10 
IV.  ASSESSING PROPOSED PROPRIETARY NAMES IN PILOT PROGRAM......................................10 
A.  SAFETY REVIEW...........................................................................................................................................11 
1.  Preliminary Screening............................................................................................................................11 
2.  USAN Stem Search..................................................................................................................................13 
3.  Orthographic and Phonological Similarities..........................................................................................13 
4.  Computational Methods..........................................................................................................................15 
5.  Medication Error Data...........................................................................................................................16 
6.  Name Simulation Studies........................................................................................................................17 
7.  Failure Mode and Effects Analysis.........................................................................................................21 
8.  Nonprescription Drug Products Analysis...............................................................................................24 
B.  PROMOTIONAL REVIEW (OPTIONAL)............................................................................................................25 
1.  Participation in the Promotional Review Element of the Pilot Program................................................25 
2.   Evaluation...............................................................................................................................................26 
3.  Research Methodology............................................................................................................................26 
V.  WHAT WILL FDA CONSIDER WHEN EVALUATING PILOT SUBMISSIONS?............................30 
A.  STANDARDS..................................................................................................................................................30 
B.  ASSESSING THE DATA, METHODS, AND EVALUATION..................................................................................30 
C.  INCREASING TRANSPARENCY........................................................................................................................31 
APPENDIX A:  COMPUTERIZED RESOURCES...............................................................................................33 
APPENDIX B:   PROPOSED TEMPLATE FOR A PILOT PROGRAM SUBMISSION..............................36 
 
 
 
8455 FINALConcept Paper.doc    Concept Paper 
 
 
PDUFA Pilot 
Project 
Proprietary Name Review  
 
 
 
 
 
I.  INTRODUCTION 
On September 27, 2007, President Bush signed into law the Food and Drug Administration 
Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 823 (FDAAA)), which includes the 
reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA IV).  The 
reauthorization of PDUFA significantly broadens and strengthens the Food and Drug 
Administration's (FDA) drug safety program, facilitating more efficient development of safe and 
effective new medications for the American public.  As part of the reauthorization of PDUFA 
IV, FDA committed to certain performance goals in its goals letter.1  As one of these goals, FDA 
stated that it would use user fees to implement various measures to reduce medication errors 
related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, 
dose designations, and error-prone label and packaging designs.   
In addition, FDA agreed to develop and implement a pilot program to enable pharmaceutical 
firms participating in the pilot to evaluate proposed proprietary names and to submit the data 
generated from those evaluations to the FDA for review.2  In accordance with these goals, FDA 
has developed and will implement such a pilot program.  Using best practices when carrying out 
their own proprietary name reviews and providing FDA with the data that result from those 
reviews may help pharmaceutical firms choose appropriate proprietary names for their products 
before application submission.  The goals of the program are to minimize the use of names that 
are misleading or that are likely to lead to medication errors, to make FDA's application review 
more efficient, and to make regulatory decisions more transparent.  At the end of the pilot, FDA 
will evaluate the results to determine whether the model of industry conducting reviews, 
submitting the results to FDA, and FDA reviewing the data is feasible and a better model than 
FDA conducting de novo reviews of proprietary names. 
                                              
1 See goals letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the 
House of Representatives, as set forth in the Congressional Record, at http://www.fda.gov/oc/pdufa4/pdufa4goals.html. 
 
2 For more on FDAAA, PDUFA 4, and the goals letter, see http://www.fda.gov/oc/pdufa/default.htm. 
 
 
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FDA has identified the following goals for the pilot program as part of the process of fulfilling 
the provisions of the goals letter: 
 
1. Hold a public technical meeting (held June 2008) to discuss the planned pilot program and 
the reviews that will be completed as part of the pilot program  
2. Make available by the end of FY 2008 a concept paper describing the pilot and the 
proprietary submissions that will be made as part of the pilot (this concept paper)   
3. Begin enrollment into the pilot program by the end of FY 2009  
4. Evaluate the pilot program by the end of FY 2011 (or subsequent to accruing two years of 
experience with pilot program submissions) to determine whether it is feasible and 
efficient to have applicants perform their own name analysis and submit resulting data to 
FDA 
 
II.  BACKGROUND 
 
During the past two decades, FDA has considered the role of names and naming processes in 
medication errors as part of the Agency's focus on the safe use of medical products.  FDA has 
developed internal procedures and processes that are part of its marketing application review 
process for evaluating the potential for a proposed product name (submitted as part of a new drug 
application (NDA), biologics license application (BLA), or abbreviated new drug application 
(ANDA)) to cause or contribute to medication errors.  The goal of this pilot program is to test a 
process that could enable pharmaceutical manufacturers to carry out proprietary name reviews of 
their products prior to submitting marketing applications to FDA, so that the FDA review of 
proprietary names would be more efficient.    
 
The following discussion reviews briefly how naming can contribute to medication errors and 
what recent activities have lead to current efforts to involve product sponsors in the drug name 
review process.   
 
A.  Medication Errors 
 
The FDA uses the definition of a medication error as set forth by the National Coordinating 
Council for Medication Error Reporting and Prevention (NCC MERP).  Specifically, a 
medication error is any preventable event that may cause or lead to inappropriate medication 
use or patient harm while the medication is in the control of the healthcare professional, patient, 
or consumer.  Such events may be related to professional practice, healthcare products, 
procedures, and systems, including prescribing; order communication; product labeling, 
packaging, and nomenclature; compounding; dispensing; distribution; administration; education; 
3
monitoring; and use.   It is important to note that some medication errors might be preventable 
                                              
3 National Coordinating Council for Medication Error Reporting and Prevention (Definition of Medication Error) at 
http://www.nccmerp.org/aboutMedErrors.html. 
 
 
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events and that the risk of these errors might be detected in the premarket stage of product 
development using appropriate evaluation  methods.   
 
Medication use errors may occur due to sound-alike or look-alike names, unclear labels, or 
4
poorly designed packaging.   In the U.S. healthcare system, healthcare practitioners rely on a 
products name as the critical identifier of the appropriate therapy in a market of thousands of 
products. Therefore, accurate interpretation of a product's name is essential to ensure that the 
correct product is procured, prescribed, prepared, dispensed, and administered to the patient.  
Product names that look or sound alike can lead to medication errors and, potentially, to patient 
harm by increasing the risk of a healthcare practitioners misprescribing or misinterpreting the 
correct product name, dispensing and/or administering the wrong product, or dispensing it 
incorrectly. 
 
Because product name confusion can occur at any point in the medication use process, FDA 
considers the potential for confusion throughout the entire U.S. healthcare system, including 
product procurement, prescribing/ordering, dispensing, administration, and monitoring the 
effects of a medication.5   
 
Medication use within a healthcare organization can be viewed as a system, with several 
components and processes: inputs (patient and drug therapy information), throughputs (care 
6
provided), and outputs (effective, efficient, and safe treatment).   Depending on the setting and 
organization, there are many variables potentially interacting within this system.  Such variables 
may include, but are not limited to:  
 
  Different processes and procedures 
  Different types of healthcare practitioners involved 
  Different patients 
  Different products 
  Different storage and dispensing conditions 
  Different available technologies 
  Different environmental conditions such as lighting, distractions, and workload 
 
Because of the many potential interactions among the system elements, multiple opportunities 
for medical care-related confusion and medication errors exist.   
 
This concept paper explains how an applicant who chooses to participate in the pilot program 
could assess a proposed proprietary name for safety (i.e., potential for medication errors), and, at 
the applicant's option, for promotional implications,  before application approval and subsequent 
                                              
4 Institute of Medicine, To Err is Human  Building a Safer Health System (1999). 
5 Institute of Medicine, Preventing Medication Errors.  
6 Joint Commission on Accreditation of Healthcare Organizations, Medication Use:  A Systems Approach to 
Reducing Errors. 
 
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marketing of a product in the United States and submit the results of the assessment for review 
under the planned program, as outlined in the goals letter.     
 
As described more fully in the next section, the evaluation of proprietary names has been 
discussed numerous times in the past. 
 
B.  2003 FDA Public Meetings on Drug Naming 
 
In June 2003, the FDA, together with the Institute for Safe Medication Practices (ISMP) and the 
Pharmaceutical Research and Manufacturers of America (PhRMA), held a public meeting to 
discuss the proper approach to proprietary name evaluation.  This meeting was the first public 
discussion of current methods to screen potential proprietary drug names for similarities to 
names of currently marketed drugs.  Much of the information on the FDAs name evaluation 
process presented at the meeting is available on the FDA Web site.7  Specific topics discussed at 
the June 2003 meeting included: 
 
  The size, qualifications, and best use of internal expert teams to evaluate proprietary 
names 
  Challenges in designing questionnaires for the assessment of proprietary names 
  The methodology for conducting a Failure Mode and Effects Analysis (FMEA) 
  Handwritten prescription and medication requisition recognition techniques 
  Use of computational linguistic methods and string matching to identify sound-alike or 
look-alike proprietary names 
  Sampling frames and methods to identify name evaluation study participants 
  Use of computer-assisted decision analysis tools   
 At the June 2003 public meeting, many meeting participants offered these views:  
 
  Prescription and order simulations should reflect actual situations as much as possible.  
  Simulations should replicate medication order situations with known error vulnerabilities.   
  The risk of a medication error can be increased or reduced, depending upon how 
medication orders are communicated (e.g., oral, written, physician order entry, or 
electronic prescribing).   
  Simulations should include not only the product name, but also the strength, route of 
administration, quantity to dispense, directions for use, and patient age and weight (for 
pediatric patients).   
  Nonprescription (over-the-counter or OTC) drug products should also be subject to the 
same proprietary name testing standards as prescription drug products. 
                                              
7 See http://www.fda.gov/cder/meeting/drugNaming.htm. 
 
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More global issues were also discussed at the meeting.  Specifically, stakeholders in the drug 
application process indicated that they consider the current proprietary name testing approach to 
be only qualitative in nature.  The processes and outcomes of the Agencys proprietary name 
review were perceived as inconsistent across reviews and FDA approval units, and most of the 
current approaches to proprietary name reviews could not be validated or reproduced.  Because 
of these issues, the stakeholders and FDA expressed the opinion that there is no gold standard 
for testing proprietary drug product names to assess the risk of error.  However, all of the 
methods discussed were considered to offer value in the name testing process and, in the absence 
of a gold standard, participants stated that multiple tests should be conducted complementarily 
with a systematic approach, and standardized tools should be applied.   
 
C.  December 2003 Meeting 
 
In December 2003, FDA held a meeting of its Drug Safety and Risk Management Advisory 
Committee (DSARM).  At that meeting, the June 2003 public meeting results were reviewed, 
additional topics in proprietary name evaluation testing were presented, and public comments 
were elicited.  Materials from the December 2003 meeting are available on the FDA Web site.8  
 
At the December meeting, the DSARM concluded that, although the current name testing 
approaches appeared logical and were under refinement, a scientifically valid, outcomes-based, 
data-driven approach to analyzing proprietary drug product names still did not exist. 
 
D.  June 2008 Meeting 
 
A third public meeting was held June 5 and 6, 2008, which focused on subsequent developments 
in the science and practice of proprietary name analysis since the 2003 meetings, the strength of 
evidence for the current approaches to name review for both prescription and nonprescription 
products as discussed in the draft of this concept paper, the elements of best practice in testing in 
the absence of a gold standard, and on details of how the planned pilot program should be 
structured and evaluated.   Comments on the proposed pilot were also filed in Docket number 
FDA-2008-N-0281 after the public meeting.   
All of the proposed evaluation methods were judged by individual experts participating in the 
public meeting to be complementary and considered to offer value in the name testing process. 
One new method was proposed, Socio-Technical Probabilistic Risk Assessment (STPRA), as an 
emerging tool for consideration.9  Many commenters encouraged FDA to incorporate consumers 
as well as frontline practitioners in every name evaluation. Many commenters also recommended 
that OTC proprietary names be screened using both consumer and healthcare-based testing 
because many of these products are recommended by healthcare practitioners and are used in 
inpatient and long-term care settings.   
This concept paper incorporates changes made in response to the comments made at the public 
meeting or submitted to the related docket.  This concept paper contains: 
                                              
8 See http://www.fda.gov/ohrms/dockets/ac/03/slides/4007s1.htm. 
9 See http://www.fda.gov/ohrms/dockets/ FDA-2008-N-0281. 
 
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(1) A summary of plans and logistics to date on the proposed pilot program  
(2) Recommendations, based on FDA's current review processes, on how applicants who 
choose to participate in the pilot program can assess a proposed proprietary name for 
safety (i.e., potential for medication errors) and provide that information to FDA. 
(3) Recommendations on how pilot participants, may also, at their option, assess and 
provide information regarding promotional implications of the proposed proprietary 
name.  
(4) A discussion of how the Agency will evaluate the pilot project submissions 
   
Some general information on data sources is provided in the Appendix.  
 
 
III.  PDUFA PILOT PROGRAMLOGISTICS 
 
As outlined above, one of FDAs performance goals under PDUFA IV is to develop and 
implement a pilot program that would enable participating pharmaceutical firms to evaluate 
proposed proprietary names and submit the data generated from those evaluations to the FDA for 
review.  Using best practices when carrying out their own proprietary name reviews and 
providing FDA with the resulting data may help ensure that pharmaceutical firms are able to 
choose appropriate proprietary names for their products before submitting their applications 
(e.g., not misleading or likely to lead to medication errors), thus making FDA's application 
review more efficient and transparent and reducing the likelihood of rejection.   
 
FDA intends the following general plans for the pilot project.   
 
A.  What Are the General Logistics of the Pilot Program? 
 
Although procedures for registration for participation in the pilot program are still being 
developed, FDA expects that enrollment in the pilot program for proprietary name analysis will 
begin by the end of FY 2009 (September 30, 2009).  Participation in the pilot program will be 
voluntary for applicants, though the FDA expects that many applicants will be interested in 
participating.  To help manage workload, as described below, applicants will be asked contact 
FDA and register before making their proprietary name submissions. Notice of the procedures 
will be published and a date for registration to begin will be established.     
 
The FDA hopes that during the two-year enrollment period, 25 to 50 proposed proprietary name 
submissions will be received and reviewed under the pilot program.  To achieve this goal and 
manage workload within the PDUFA IV timelines, the FDA plans to accept on average one or 
two submissions per month. The FDA will strive to include a cross-section of applicants that 
represent large, medium, and small companies.  We recognize that some companies may contract 
this work out to third party vendors.  We welcome these submissions.  As FDA does not control 
the selection of these vendors, the pilot program has no mechanism to ensure a wide number of 
 
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vendors will be represented in this program.  The FDA expects that enrollment will last for two 
years, after which the FDA will evaluate the pilot program.  
 
For applicants not participating in the pilot program, proposed name submissions will be 
analyzed and evaluated using FDAs traditional approach to the review of proposed proprietary 
names.  
 
B.  How Will the Pilot Program Function? 
 
Applicants can submit a proprietary name analysis to the FDA (i.e., CDER or CBER) either 
during the investigational new drug application (IND) process, or as part of the initial submission 
of the NDA, BLA, or ANDA.  Submissions during the IND phase will be accepted only for 
products that have completed phase 2 of clinical development.   
 
As soon as an applicant has determined that it would like to participate in the pilot program and 
has selected a specific proprietary name that it desires to evaluate and submit, the applicant 
should contact FDA to register and indicate the approximate date of the intended submission. 
This will enable FDA to manage workflow under the pilot program.  . Applicants should then 
contact the appropriate center 120 days prior to the intended date of the proposed proprietary 
name submission to discuss specific details of the planned submission.   
 
Applicants can communicate with FDAs project managers regarding questions about their 
proposed submissions.  If necessary, the applicants will be asked to submit their questions in 
writing; in some cases, a face-to-face meeting to discuss the planned submission may be 
appropriate.   
 
C.  What If I want to Deviate from the Process in the Concept Paper? 
 
Although participation in the pilot program is entirely voluntary, all pilot participants are 
expected to provide information evaluating the safety (potential for medication error) presented 
by their proposed proprietary name.  Applicants can still participate in the pilot program if they 
plan to deviate from the proposed proprietary name safety evaluation process outlined in this 
concept paper and instead use additional or alternative methods.  Applicants can also participate 
in the pilot program without submitting any information to evaluate the promotional implications 
of their proposed proprietary names (see section IV.B). However, the pilot program will not 
accept applications that include only an evaluation of the promotional implications of a proposed 
proprietary name. 
 
For prescription products, applicants should inform the appropriate center at the 120-day pre-
submission discussion (recommended above) if they plan to use alternative or additional methods 
to evaluate the safety of their proposed proprietary name.  However, the FDA does not have the 
resources and, therefore, does not intend to review proposed alternative methodologies with the 
intent of coming to agreement with an applicant on the appropriateness of these alternative 
methodologies prior to submission.  In such cases, the FDAs review of the alternative 
methodologies will occur during the review of the actual submission.  Consideration will be 
 
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given to the strengths and limitations of the alternative method(s) in addition to assessing the 
adequacy of the data submitted in support of the proposed alternative.   
 
For nonprescription products, FDA encourages sponsors to discuss with the Agency different 
protocols that could be used for their specific products prior to submission of the proprietary 
name (see section IV.A.8). 
 
D.  Why Do I Have to Make Two Submissions?   
 
For purposes of the pilot program, applicants will be asked to submit two separate sets of drug 
name-related information to enable the FDA to conduct parallel reviews.  The first set should 
include the applicants comprehensive evaluation of the proposed proprietary name as described 
in Section IV of this paper (a recommended template has been provided in Attachment B).  The 
second submission should include the information applicants submit under the Agency's current 
practice.10  These two sets of materials will enable  FDA to perform two separate, independent 
reviews in parallel and compare the results as described below.  
 
The first review will evaluate an applicants proprietary name using the data submitted by the 
applicant obtained from the test methods outlined in this paper.  The second review will 
independently analyze the proposed proprietary name using the FDAs traditional approach to 
review of proposed proprietary names.  The two reviews will be conducted by two different 
reviewers, who will not share with each other any details of the data or other findings during the 
review process.  At the end of the review process (i.e., when each reviewer has come to a 
conclusion regarding the acceptability of the proposed proprietary name), the two reviewers, 
along with other FDA experts in proprietary name review, will meet to discuss the data and their 
conclusions.  At that time, the two reviewers will note any differences in the data, findings, and 
conclusions between the two analyses and reviews.  Discussion will focus both on the 
differences in the outcomes of specific analyses, as well as on differences in the overall 
conclusion regarding the acceptability of the proposed proprietary name.  The FDA will exercise 
its scientific judgment in determining the overall acceptability of the proposed name based on all 
available data.  All noted differences in the specific analyses and conclusions will be shared with 
the applicant once a final decision has been made. 
  
E.  What Happens To My Submission and How Will It Be Reviewed? 
 
Once the FDA receives a proprietary name submission under the pilot program, it will determine 
if the submission contains the comprehensive information essential for evaluation of the 
proposed name.  A comprehensive submission is one that contains: 
 
  At least one proposed proprietary name 
  Identification of the first-choice proprietary name, if more than one name is submitted 
                                              
10 FDA is developing guidance on the contents of a  complete submission for the evaluation of proprietary names, to address the 
materials recommended to support review under its current approach.  
 
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  Data-driven analyses of the acceptability of the proposed proprietary name, including a 
clear description of the methods, the data sources, and the raw data   
  Information needed to evaluate the proprietary name under the traditional review process 
(i.e., proposed name, product profile, labels, and labeling)  
 
The FDA will encourage applicants to submit proprietary name evaluations based on the 
methods set forth in the concept paper.  However, an applicants completion and submission of 
these evaluations is not necessary for the FDA to consider a submission complete.  Applicants 
can submit alternative evaluations. If, on their face, these evaluations are data-driven, the FDA 
will accept the submissions.  Review of the alternative methodologies will occur during the 
review of the actual submission.   
 
If the FDA determines that a submission of a proprietary name evaluation is incomplete, it will 
inform the applicant promptly.   
 
F.  Will IND and NDA/BLA Submissions Be Handled Differently? 
 
When the FDA receives a submission of a proposed proprietary name evaluation under the pilot 
program during the IND phase, it will aim to complete its two independent reviews and arrive at 
a decision within the review performance goal timelines stipulated under PDUFA IV (180 days 
from receipt of complete submission, i.e., submission of information needed to evaluate the 
proprietary name, in 50 percent of cases in FY 2009 and 180 days in 70 percent of cases in FY 
2010).  When the FDA receives a submission of a proposed proprietary name evaluation under 
the pilot program at the time an NDA or BLA is submitted, it will aim to complete its two 
independent reviews and arrive at a regulatory decision within the review performance goal 
timelines stipulated in PDUFA IV (90 days in 50 percent of cases in FY 2009 and 90 days in 70 
percent of cases in FY 2010).  Proprietary names submitted as part of an ANDA are not subject 
to the performance goals stipulated in PDUFA IV, but will be reviewed with a goal of 180 days.  
 
G.  What Will the Agency Review in Determining a Proposed Name's Acceptability? 
 
Once the FDA determines that a submission of a proprietary name evaluation contains the 
comprehensive information essential for substantive review, the parallel reviews will begin.  The 
FDA will assess and review the adequacy of the data from the applicants analysis and from the 
FDAs independent analysis.  A regulatory decision on the acceptability of a proposed 
proprietary name will be based on review of all available data (i.e., the applicants evaluation and 
FDAs independent analysis).  In addition, the FDA will use the data to evaluate the overall pilot 
program.  
 
H.  What If My First Choice Name is Not Acceptable? 
 
Under the pilot program, the FDA will continue its long-standing practice of reviewing the first-
choice name.  If the FDA determines that the first-choice name is acceptable, the FDA will not 
review the second-choice name.  If the FDA determines that the first-choice name is not 
 
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acceptable, the proprietary name review clock established under the goals letter11 will be 
stopped. At that time, the FDA will notify the applicant, in writing, of its decision regarding lack 
of acceptability of the proposed first-choice name.  The proprietary name review clock will not 
re-start until the applicant either has informed the FDA, in writing, that it would like its 
originally submitted second-choice name reviewed, or until FDA receives an applicant's 
submission of an alternative second-choice name along with the comprehensive information 
described below in section III F.   At that time, the FDA will begin review of the second-choice 
name.  In the latter scenario, if an applicant has submitted a complete proprietary name analysis 
for the second-choice name, the responsible center will use discretion to determine whether to 
review the applicants analysis in addition to conducting its own analysis using the traditional 
approach.  Although the FDA would ideally review the applicants completed proprietary name 
analysis for the second-choice name, factors such as staffing and timelines will be used in 
making this determination.  
 
I.  When and How Will the Pilot Program Be Assessed? 
 
At the end of FY 2011, or subsequent to accruing two years of experience with pilot program 
submissions, the FDA will evaluate the pilot program to determine whether to have applicants 
perform their own name analysis and submit resulting data to FDA for review.  The FDA 
anticipates that evaluation of the program will focus primarily on a comparison of the 
conclusions the FDA has reached after review of applicants analyses of proposed proprietary 
names to those the FDA reaches after its own analyses.  In addition, the FDA intends to examine 
patterns, if any, of differences between its analyses and those performed by applicants and 
between its interpretation of the results of specific applicant analyses, applicants interpretations 
of the same results, and the ultimate regulatory decision that was made.  The FDA expects that 
these evaluations will be largely qualitative.  Any quantitative evaluations will be descriptive.  
The results of this pilot program and recommended additions and changes to methods based on 
the reported results will be discussed in a future public meeting. Following this meeting, draft 
guidance will be published describing the best test methods for proprietary name evaluation.  
 
 
IV.  ASSESSING PROPOSED PROPRIETARY NAMES IN PILOT PROGRAM 
 
In the following sections, proposals and recommendations about how to assess proprietary names 
reflect the Agency's thinking and processes as currently practiced.  The goals in Section IV are 
two fold: (1) explain and clarify what the Agency's current assessment involves and (2) 
recommend approaches pharmaceutical manufacturers should use when performing their 
assessments under the pilot program.  
 
 
                                              
11 See section IX.A. of the goals letter, establishing review performance goals for proprietary names. This proprietary name 
review clock is distinct from the review performance goal clock for the underlying NDA/BLA submission, addressed in 
section I.A. of the goals letter. 
 
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FDA review of proprietary names includes consideration of both safety and promotional aspects.  
FDAs primary consideration when evaluating the acceptability of a proposed proprietary name 
is avoiding the risk of medication errors.  This safety review is based on the findings of a Failure 
Modes and Effects Analysis (FMEA) of the proprietary name.  In its safety review, FDA not 
only considers the potential for a name to be spelled similarly and/or sound similar to the name 
of a currently marketed product or one that is in the approval pipeline, but also considers the 
potential for the proposed name to inadvertently function as a source of error for other reasons, 
such as by suggesting a dosage form or route of administration. Consideration is given to the 
proposed product's characteristics (including its intended use, dosage form, strength, and route of 
administration) because the product characteristics provide a context for communication of the 
product name and ultimately determine the use of the product in the usual clinical practice 
setting.  FDA believes that no single test is sufficient to reach a conclusion that a proprietary 
name is acceptable.  FDA emphasizes that the best approach has proved to be the use of a 
combination of tests to evaluate name appropriateness.  
 
The promotional review of proposed names considers whether the name functions to overstate 
the efficacy, minimize the risk, broaden the indication, or make unsubstantiated superiority 
claims for the product, or is overly fanciful" by misleadingly implying unique effectiveness or 
composition . (See 21 U.S.C  321(n), 352(a) & (n); see also 21 CFR  201.10 (c)(3), 
202.1(e)(5)(i) &(e)(6)(i).).   
 
The following sections provide a more detailed snapshot of the Agency's proprietary name 
review.  Please note that the promotional assessment of a proposed proprietary name as 
described in this paper will be optional for applicants participating in the pilot program.  If 
applicants choose not to participate in the promotional review component of the pilot program, 
the Agency will conduct the promotional review using its traditional approach.  
 
A.  Safety Review 
 
FDAs safety review of a proprietary name involves methods that generate a list of names that 
could be confused with the proposed proprietary name as well as methods to test the likelihood 
of confusion between these names and the proposed proprietary names. 
 
1.  Preliminary Screening 
 
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Names often fail FDAs screening process for readily identifiable reasons.  Box 1 lists four 
naming characteristics that when incorporated into a proprietary name, may cause or contribute 
to medication errors. If a proposed name fails the preliminary screening, it is unlikely to be a 
viable candidate for a proprietary name.  FDA recommends that applicants carefully consider the 
factors listed in Box 1 in conducting a preliminary screening of their proprietary name for 
acceptability prior to testing.  
Box 1:   Naming Characteristics Known to Cause or Contribute to Medication Errors  
 
Dosing Interval 
The FDA discourages proprietary names that incorporate or suggest a dosing interval (e.g., NameBID).  Drug 
product characteristics and/or drug release characteristics are subject to change over time with approval of new 
dosing intervals, thus possibly rendering the original proprietary name misleading.  
 
Dosage Form/Routes of Administration 
Generally, the FDA discourages the use of proprietary names that incorporate or suggest a particular dosage 
form (e.g., Nametabs, Namecaps) or route of administration (e.g., Nameoral).  Avoiding the suggestion of a 
dosage form or route of administration in the name will enable a company to use the same proprietary name for 
future dosage forms of the product without making the proprietary name misleading.   
 
Medical And/Or Product Name Abbreviations 
The use of common medical abbreviations and coined abbreviations in a proprietary name may be 
misinterpreted and therefore should generally be avoided.  Abbreviations commonly used for 
prescription communication, especially abbreviations recognized as error-prone and potentially 
dangerous by the Institute for Safe Medication Practices 
(www.ISMP.org/tools/errorproneabbreviations.pdf) and the National Coordinating Council on 
Medication Error Reporting and Prevention (www.nccmerp.org), should be avoided.   
 
Names That Include or Suggest the Composition of the Drug Product  
Generally, proprietary names that include or suggest the composition of a drug product may be considered 
misleading if the proprietary name includes or suggests the name of one or more, but not all, of its ingredients 
(21 CFR 201.6(b)).  In addition, a proprietary name would generally be considered misleading if it includes or 
suggests the name of an ingredient that is not included in the drug product.  
 
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2.  USAN Stem Search  
 
In its review of drug names, the FDA screens proposed proprietary names against the stem list 
created by the United States Adopted Names (USAN) Council.  The purpose of the Council is to 
serve the health professions in the United States by selecting simple, informative, and unique 
nonproprietary names for drugs products. Selections are made by establishing logical 
nomenclature classifications based on pharmacological and/or chemical relationships. 
 
The USAN Council (tri-sponsored by the American Medical Association (AMA), the United 
States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA)) 
works closely with the International Nonproprietary Name (INN) Programme of the World 
Health Organization (WHO) and various national nomenclature groups to achieve global 
standardization and unification of drug nomenclature and related rules with the goal of ensuring 
that drug information is communicated accurately and unambiguously. 
 
Because the USAN stems are intended to indicate a pharmacological or chemical trait of a drug,  
a single stem will be applicable to multiple drug products.  Use of these stems in proprietary 
names, even when used consistently with the USAN meaning, can result in multiple similar 
proprietary names and proprietary names that are similar to established names, thus increasing 
the chance of confusion among those drugs. To reduce the potential for confusion, USAN stems 
should not be incorporated into proprietary names, and FDA recommends that applicants screen 
potential proprietary names against the USAN stem list, and eliminate those that would 
incorporate USAN stems. 
 
In evaluating a potential proprietary name against the USAN stem list, the position of the letters 
that compose the USAN stem is important.  For example, the letter sequence Gli- only 
functions as a USAN stem when used as a prefix as defined by the USAN Council.  An example 
of an unacceptable proprietary name including the USAN stem Gli- is Glidrug.  Conversely, 
if the same letter sequence that makes up the USAN stem appears in an alternate position in the 
proposed name, it may be acceptable.  An example of a proprietary name including the letter 
sequence Gli- without implicating a confusing use of a USAN stem is Druggli.  FDA 
recommends that all proprietary name submissions made under the pilot include a statement 
indicating that the name does not contain a USAN stem of any size (e.g., does not contain the 
letter sequence in the position designated as a stem by USAN) and the date on which this 
information was searched on the USAN list. 
 
3.  Orthographic and Phonological Similarities 
 
When reviewing a proposed proprietary name, the centers consider the spelling of the name, 
pronunciation of the name when spoken, and appearance of the name when scripted throughout 
the medication use system (e.g., prescribing, dispensing, administering).  The staff compare the 
spelling of the proposed proprietary name with the proprietary and established names of existing 
and proposed drug products because similarly spelled names may have greater likelihood to 
sound similar to one another when spoken, or look similar to one another when scripted.  
 
 
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In addition, the centers will examine the orthographic appearance of the proposed name using a 
number of different legible handwriting samples.  Handwritten communication of product names 
has a long-standing association with product name confusion, often leading to medication errors.   
 
The centers apply expertise gained from root-cause analysis of such medication errors to identify 
sources of ambiguity within the name that could be introduced when scripting (e.g., T may 
look like F, lower case "a" looks like a lower case "u," a capital A may look like Ci or 
Cl, a lowercase en may look like ar, in, or ea), along with other orthographic 
attributes that determine the overall appearance of the product name when scripted (see detail in 
Table 1 below).  Additionally, since spoken communication of medication names is common in 
clinical settings, the centers compare the pronunciation of the proposed proprietary name with 
the pronunciation of other product names, accounting for the potential for phonological error due 
to predictable phonological variance.   
 
The majority of names with similarity to the proposed proprietary name can be identified through 
database searches.  A variety of publicly available databases and resources containing product 
names can be used to identify similar names.  The FDA uses such databases, the Internet, and 
other printed and electronic drug product resources to search for orthographic and phonological 
name similarities.  
 
The FDA proposes that applicants also conduct an extensive search to identify any existing 
names that are similar to the proposed proprietary name or names with orthographic and 
phonological similarity to the proposed proprietary name.  The examples in Table 1 should be 
useful in this search.  It is recommended that applicants search a variety of sources and, at a 
minimum, search the publicly available databases listed in Appendix A.  We recognize that 
applicants do not have access to proposed proprietary names that are in the FDA review pipeline.  
Such a limitation will be documented in FDAs final review. 
 
The FDA proposes that applicants submit the following information with their applications: 
 
  All search queries 
  The system parameters used for each search (e.g., letter substitution) 
  The precise databases searched 
  Any thresholds imposed on the output (e.g., top 100, top 200, etc.) 
  The date the search was conducted or the last update of the database that was searched 
  Pooled results with source citation and full product characteristics of each name identified as 
a possible source of confusion with the proposed name. 
 
 Note:  Although such searches generate many names that may be ruled out under further 
analysis, we request that applicants submit all names originally identified as potentially similar to 
the proposed name.  
 
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Table 1:  
Criteria Used to Identify Product Names that Look or Sound Similar to a  
Proposed Proprietary Name 
  Considerations when searching the databases 
Type of  Potential causes of  Attributes examined to   Potential Effects 
similarity   product name  identify similar product 
similarity  names 
  Similar spelling  Identical prefix  Names may appear similar in 
    Identical infix  print or electronic media and lead 
  Identical suffix  to product name confusion in 
  Length of the name  printed or electronic 
  Overlapping product  communication 
Look-alike  characteristics   
Names may look similar when 
scripted and lead to product name 
confusion in written 
communication 
Orthographic  Similar spelling  Names may look similar when 
similarity  Length of the name  scripted, and lead to product 
Upstrokes   name confusion in written 
Downstrokes  communication 
Cross-stokes 
Dotted letters 
Ambiguity introduced by 
scripting letters  
Overlapping product 
characteristics 
Sound-alike  Phonological  Identical prefix  Names may sound similar when 
similarity   Identical infix  pronounced and lead to product 
  Identical suffix  name confusion in spoken 
Number of syllables  communication 
Stresses  
Placement of vowel sounds 
Placement of consonant 
sounds 
Overlapping product 
characteristics 
 
4.  Computational Methods 
 
To complement the above-delineated process, FDA may use a computerized method to identify 
any phonological and orthographic similarities between product names.  FDA recommends that 
applicants use such a program.  Although these computerized methods are useful in hypothesis 
generation (i.e., developing the list of possible names that could be confused with the name 
under review), they should not be used for the more complex task of hypothesis testing (i.e., 
evaluating which names have potential for error and harm).  No single method can evaluate all 
dimensions of similarity, nor will any single measure perform as well an intelligently assembled 
combination of measures (e.g., one that integrates measures of orthographic, phonological, and 
semantic similarities). 
 
 
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There are reasons why computerized methods and algorithms are not useful for hypothesis 
testing. First, programs that use String-edit distance and Bigram pairs do not fully evaluate the 
similarity of names, particularly with respect to orthographic appearance.  Predictions based on 
computerized measures of similarity will occasionally yield both false positive predictions (i.e., 
saying a pair is confusing when it is not) and false negative predictions (i.e., saying a pair is not 
confusing when it really is). 
 
Although the computerized methods and algorithms provide reproducible measures of similarity 
or dissimilarity, these measures are difficult to interpret when the scores reveal moderate 
similarities or dissimilarities between the names.   
 
The FDA proposes that applicants use computerized methods and algorithms that can detect the 
similarity of product names from a phonological perspective, orthographic perspective, or both. 
In submitting computational data, the FDA recommends that applicants provide the following 
information: 
 
  The measure of similarity/distance used 
  The values assigned to any adjustable parameters 
  The manner in which non-name attributes (e.g., strength, dosage form, route of 
administration) were handled 
  If a weighting scheme was used, describe how the different elements were weighted 
  The precise database searched (e.g., Orange Book, including or excluding discontinued 
products, USPTO (what class), Multum Lexicon). 
  If a cutoff or threshold was used to narrow or widen the search results, the cutoff or 
threshold, and how and why it was chosen 
  Testing output 
 
5.  Medication Error Data  
 
FDA believes that data obtained from case reports of medication errors help to inform the 
analysis of a proposed proprietary name and overall product design (e.g., packaging, labels, and 
labeling).  The FDA searches databases containing medication error reports with the goal of 
identifying relevant information about potential errors before approval.  
 
FDA recommends that when a proposed product contains an active ingredient that is marketed 
domestically or abroad, all available information relevant to medication error cases associated with 
that active ingredient be identified and submitted to the FDA.  Applicants can obtain medication 
error report information from their own safety databases.  Medication error report data also can be 
obtained from published literature, and any other relevant databases (e.g., data collected by other 
regulatory authorities as set forth in Appendix A).   
 
Relevant information would include any error reports related to the product nomenclature 
(established and proposed proprietary name), product design, label, and labeling.  This 
information should be identified and reported to the FDA in line listings with a narrative as 
described in Box 2.  
 
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Box 2:  Format for Submitting Relevant Information 
 
  The FDA recommends that applicants submit a line listing and narratives of the medication error 
case reports identified in the postmarket period for marketed products with the same active 
ingredient as the product under review. 
  The applicant should cite the source of the report along with any analysis conducted by the 
applicant.   
  Applicants should submit the full text of any article published on medication errors associated 
with the product.   
  Applicants should also categorize these errors by type (e.g., incorrect product, incorrect route of 
administration) using the NCC MERP taxonomy.   
  Applicants should review these cases to identify factors that contributed to the medication errors 
and to ascertain whether these risks apply to the proposed proprietary product name.  All 
medication error data should be integrated into the FMEA. 
 
 
 
6.  Name Simulation Studies 
 
FDA performs limited internal simulation studies to test the response of healthcare practitioners 
to proposed names.  FDA believes that applicants should consider the following elements when 
planning the use of simulation studies.  
 
a.  General description 
 
Generally, name simulation studies test the response of practitioners to a proposed name by 
asking them to use the name in simulated real-world conditions.  The more closely the simulation 
approximates real use conditions, the more valuable the simulation.  At a minimum, certain 
characteristics of real use conditions are easily simulated and should be present (e.g. in the use of 
lined paper, prescription pads, and telephone orders to approximate inpatient written, outpatient 
written and outpatient verbal prescribing, respectively, and the use of background noise, different 
handwriting samples, different color inks, directions for use, and different voices/accents to 
mimic the diverse prescribing conditions).  Additionally, the simulation study should present the 
name with the corresponding product characteristics (e.g., strength, route, dosing, and frequency) 
that are likely to be used to communicate prescriptions and orders for the proposed product.  
 
b.  Study design 
 
A simulation study designed to detect close to a zero percentage error rate with statistical 
significance would require an extremely large sample size (e.g., a sample of ~26,000 would be 
 
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12
required to detect an error rate of 0.001 at the 0.05 significance level ).  We recognize that a 
study of this magnitude is not realistic.  However, we may be able to understand how a proposed 
name might perform in real world conditions through a well-designed parallel group 
observational study.  In such a study, each group represents different prescribing scenarios based 
on all of the potential prescribing conditions for the proposed product (e.g., for an inpatient 
written order, an order written by a physician using lined paper, transcribed and entered into a 
computer by a unit clerk, read and dispensed by a pharmacist, read and administered by a nurse).  
When performing simulation testing, both quantitative and qualitative data should be collected.  
Both types of data can be collected anywhere in the medication use system.  For example, 
quantitative data might document how many times a participant interpreted a prescription 
correctly and how many times it was misinterpreted.  The qualitative data would include any 
concerns or problems the participants thought of or encountered while going through the process 
(e.g., no error occurred but a participant felt that there could have been an error in a different 
situation). 
 
c.  Participants 
 
All participants in name simulation studies should be active practitioners, such as prescribers, 
transcribers, dispensers, or administrators of drugs in the proposed prescribing condition for the 
product, and should be representative of the full range of persons involved, including physicians, 
physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, ward clerks, 
and other relevant individuals..  All settings (e.g., community pharmacy, ambulatory care, 
hospital, long-term care) where the product could be used should be considered.  For example, if 
a product will be prescribed by private practice oncologists, the participants should include, but 
not be limited to, private practice oncologists, nurses working in this private practice setting, and 
other individuals who might call in a prescription from this setting.  If the product will be 
dispensed in an inpatient setting, the participants should include, but not be limited to, inpatient 
pharmacists, pharmacy technicians, ward clerks and nurses.  Consideration should be given to 
including primary care practitioners, pharmacists, and nurses even when evaluating names of 
specialty drugs to probe what medication names outside the specialty might cause error. These 
stakeholders will bring experience from different workflow and practice environments.  
 
Patients should be included in Failure Mode and Effects Analysis for all products (see section 7).   
However, the FDA does not generally consider it necessary to include patients in a name 
simulation study for a prescription product that is simulating use in an inpatient setting because 
patients are not involved in the prescribing, dispensing, and administration of medications in this 
setting of care.   
 
   
                                              
12  This calculation was made to determine whether the error rate differs from 0.001 at a 0.05 significance level and 
80% power, assuming the medication error rate of the sample is 0.0005. 
 
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d.  Number of scenarios 
 
The FDA recommends that a minimum of 20 scenarios representing each possible prescribing 
condition for the proposed drug be performed to provide an adequate descriptive assessment 
(e.g., communication from physician to ward clerk to pharmacist to nurse). Participants involved 
in a name simulation study can participate in the testing of an unlimited number of proposed 
proprietary names.  However, to minimize bias, a name should not be tested by the same 
participant more than once. The number of participants in each simulation scenario should reflect 
the actual number of participants in an actual clinical scenario.  Generally, these scenarios will 
involve 2 to 5 participants (e.g., physicianward clerkpharmacistnurse).  Table 2 provides 
20 scenarios that could be used for an inpatient setting.  We estimate that approximately 70 
participants will be needed because not all scenarios will involve the same number of 
participants (e.g., physicianpharmacist). 
 
Each possible prescribing condition for the proposed drug should be tested several times giving 
consideration to all modes of communication (e.g., spoken, written, computer order entry, 
computer selection and selection of drug from drop down menu) (see examples Table 2 below).  
For example, for a drug that is administered only intravenously in an inpatient setting, an 
outpatient simulation using a handwritten prescription may not be helpful because this product 
would not be typically used in this setting of care.  A simulation for an orally administered drug 
that could be dispensed in both in- and outpatient settings should contain all possible inpatient 
and outpatient scenarios.  Table 2 shows example scenarios for an orally administered drug.  
These example scenarios should be revised to reflect the likely setting(s) of care for the product 
and be specific to how the applicants product will be prescribed, transcribed, dispensed, and 
administered in the real-world condition.   
 
Applicants should consider embedding the test name in a list of two or three other test names of 
marketed drugs in the simulated prescriptions, or consider other simulated prescription formats 
that are designed to mimic the results of real-world settings.  Spoken orders should include 
several scenarios with an unaided pronunciation and several scenarios with a pronunciation 
based on how the applicant proposes to pronounce the name when marketed (e.g., Kaletra is 
pronounced by some as Kuh-let-ra and the applicants pronunciation is Kuh-lee-tra).  
  
Table 2: 
Example Scenarios for Name Simulation Study for an Orally Administered Drug 
Scenario  Prescribing Condition  Participant Group 
Number 
1  Inpatient: Written order on lined paper  physician A - ward clerk A  nurse A - 
pharmacist A - nurse B 
2  Inpatient: Written order on lined paper  physician assistant A - ward clerk B  nurse C 
- pharmacist B  nurse D 
3  Inpatient: Written order on lined paper  physician B  nurse E  pharmacist C  nurse F 
4  Inpatient: Written order on lined paper  physician C - ward clerk C  nurse G -
pharmacist D  nurse H 
5  Inpatient: Spoken order transcribed to a  physician D  nurse I - ward clerk D 
written order unaided pronunciation  pharmacist E  nurse J 
 
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Table 2: 
Example Scenarios for Name Simulation Study for an Orally Administered Drug 
Scenario  Prescribing Condition  Participant Group 
Number 
6  Inpatient: Spoken order transcribed to a  physician assistant B  nurse K - ward clerk E 
written order unaided pronunciation   pharmacist F  nurse L 
7  Inpatient: Spoken order transcribed to a  physician E  nurse M  pharmacist G  nurse 
written order pronunciation as intended by  N 
applicant  
8  Inpatient: Spoken order transcribed to a  physician F  nurse O - ward clerk F 
written order pronunciation as intended by  pharmacist H  nurse P 
applicant 
9  Inpatient: Direct computer entry  physician G - pharmacist I - nurse Q 
10  Inpatient: Direct computer entry  physician assistant C - pharmacist J - nurse R 
11  Inpatient: Direct computer entry  physician H - pharmacist K - nurse S 
12  Inpatient: Direct computer entry  nurse practitioner A - pharmacist L - nurse P 
13  Outpatient: Written prescription    nurse practitioner B - pharmacist M 
14  Outpatient: Written prescription    physician I - pharmacist N 
15  Outpatient: Written prescription    physician J - pharmacist O 
16  Outpatient: Written prescription    physician assistant D - pharmacist P 
17  Outpatient: Spoken prescription left on  nurse practitioner C - pharmacist Q 
voice mail unaided pronunciation  
18  Outpatient: Spoken prescription left on  physician K - pharmacist R 
voice mail unaided pronunciation 
19  Outpatient: Spoken prescription left on  nurse practitioner D - pharmacist S 
voice mail pronunciation as intended by 
applicant 
20  Outpatient: Spoken prescription left on  nurse practitioner E  pharmacist T 
voice mail pronunciation as intended by 
applicant 
21  Outpatient:  Electronic generated  physician L  pharmacist U 
prescription 
22  Outpatient:  Electronic generated  physician M  pharmacy technician A  
prescription  pharmacist V 
23  Outpatient:  Electronic generated  physician assistant E  pharmacist W 
prescription 
Total Participants  70 
 
 
 
Each participant should be interviewed at the end of the simulation using nonleading scripted 
follow-up questions.  Responses should be recorded verbatim.  All qualitative data derived from 
follow-up questioning should be coded and analyzed based on verbatim responses from the 
participants (Table 3).  When the results are submitted to FDA for review, the raw data should 
include the coded responses as well as all the verbatim data.  
 
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 Table 3: 
Examples of Coded Responses to Follow-up Questions 
Follow-up Questions  Coded responses   Participants with 
coded response  
Do you think this name looks like  Yes  8 
any other drug name?  No  52 
If yes which drug?  Brand X  3 
Brand Y  5 
Do you think this name sounds like  Yes  8 
any other drug name?   No  52 
If yes, which drug?  Brand X  8 
   
Do you think this name looks like  Yes  0 
any medical terms or laboratory  No  60 
tests? 
If yes, what terms or tests? 
Do you think this name sounds like  Yes  0 
any medical terms or laboratory  No  60 
tests? 
If yes, what terms or tests? 
Describe your overall impression of  There are many drug names on  12 
the name.  These comments do not  the market that seem to start   
necessarily have to be related to  with ___.   
safety.    Good name does not appear to  35 
be a problem   
The name seems to conflict with  13 
what the drug is suppose to treat 
 
Transparency of the study process is essential.  Applicants should submit, and the FDA will 
review, all methodology associated with the simulation studyincluding but not limited to how 
participants were chosen and the composition and qualifications (e.g., current roles in clinical 
practice) of participants. 
 
7.  Failure Mode and Effects Analysis  
 
Failure Mode and Effects Analysis (FMEA) is a systematic prospective method the FDA uses to 
examine the nomenclature, labeling, and packaging for possible ways in which a failure (i.e., an 
 
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error) can occur.13  Postmarket experience has shown that the nomenclature and design of the 
label/labeling and packaging of a product directly contributes to the occurrence and the 
likelihood of medication errors.   
 
FMEA capitalizes on the predictable and preventable nature of medication errors and enables the 
identification of failure modes prior to approval, when actions to overcome these issues are 
easier to implement than remedies available in the postapproval phase.  When performing a 
FMEA of a proposed product, the FDA considers the use of the product at all points in the 
medication system.  Applicants should do the same.  Because the proposed product is not yet 
marketed, the applicant should anticipate the use of the product under the proposed prescribing 
conditions by considering the intended indication and product characteristics.  The applicant 
should then consider the proposed product in the context of the usual practice setting and work to 
identify potential failure modes and the effects associated with the failure modes.   
 
a.  Identifying failure modes 
 
To identify potential failure modes, the applicant should compare the proposed proprietary name 
to all of the names gathered during the safety review.  The applicant should consider the 
vulnerability of the proposed name to misinterpretation and confusion and ask the following 
questions:  
 
  Could the similarity of this proposed proprietary name to other proprietary names cause 
the names to be confused with one another at any point under the proposed prescribing 
conditions?  As a guide to answering this question, one should consider the similarity or 
dissimilarity of the names in question in their entireties as to spelling, appearance, sound, 
connotation, and commercial impression. 
Are there other aspects of the proposed proprietary name, unrelated to the orthographic 
and phonological similarity that could be potentially misleading and cause confusion at 
any point under the proposed prescribing conditions?  Such errors may not necessarily 
involve confusion between the proposed drug and another drug product.  For example, the 
FDA has learned that a proposed name for a multi-ingredient product that represents only 
one of the active ingredients contained in the product14; names that may encode a 
frequency or route of administration inconsistent with the actual product characteristics; or 
names that look or sound like other medical terms, diagnostic tests, and abbreviations are 
name characteristics that could cause confusion and lead to medication errors.  
 
An applicant should support a no answer to either or both of these questions by providing FDA 
with its raw data and a summary of the basis for its conclusion that the name is not confusingly 
similar to any other names or will not otherwise cause medication error; however, for a no 
answer,  the applicant need not go on to conduct the analysis described in next section of this 
                                              
13 Joint Commission Resources, Root Cause Analysis in Healthcare 201 (3d ed, 2005). 
14 See  21 CFR 201.6(b), establishing that labeling may be misleading if the name of the drug includes or suggests the name of 
one or more but not all of its ingredients. 
 
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paper.  A response of yes to either of the above questions indicates a failure mode and 
represents the potential for a proposed proprietary name to lead to confusion and 
misinterpretation.   In the case of a yes answer, the applicant should proceed to conduct the 
evaluation described in the following section. 
 
b.  Identifying failure effects 
 
If the answers to the either of the aforementioned questions is yes, the next step in the FMEA 
is to evaluate all potential failure modes.  The potential failure modes are evaluated to determine 
the likely effect of the confusion, by asking the following question: 
 
  Could this confusion result in medication errors in the usual practice setting?   
 
The answer to this question is a central component of the FDAs overall risk assessment of the 
proposed proprietary name.  If the FMEA determines that the source of confusion is unlikely to 
ultimately cause medication errors under the proposed prescribing conditions, the proposed name 
and findings should be submitted to the FDA for further review.   
 
If the FMEA determines that the proposed proprietary name could be a source of confusion that 
could cause medication errors under the proposed prescribing conditions, an alternate proprietary 
name should be evaluated.  
 
In certain instances, the FMEA findings may suggest other risk-reduction strategies, such as 
product reformulation to avoid an overlap in strength or an alternate modifier designation that 
may reduce the risk of medication errors resulting from product name confusion.  Alternatively, 
the applicant may try to justify why the finding might not lead to a medication error or why the 
risk of medication error with the proposed name is less than risks associated with other 
alternative nomenclature options. 
 
c.  FMEA team 
 
Selection of the FMEA team is a critical step in the FMEA process.  The team should be 
multidisciplinary to ensure that different perspectives and viewpoints are brought to the process.  
The team should include a representative sample of practicing health professionals of varying 
clinical backgrounds, disciplines, and experience who would be procuring, prescribing, 
dispensing, and administering the product under evaluation as described in Section IV.A.6.c. 
above.  If a product will be dispensed in an outpatient setting, the team should also include a 
patient.  The FMEA team should include health professionals with experience in actual-use 
settings and members with expertise in the field of medication error prevention.  FMEA teams 
typically consist of 8 to 12 members.15  
                                              
15  Joint Commission on Accreditation of Healthcare Organizations, Failure Mode and Effects Analysis in Health 
Care: Proactive Risk Reduction 27 (2005).  
 
 
 
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The FDA will review the methodology associated with the FMEA including how the team was 
chosen, the composition of the team and qualifications (e.g., current roles in clinical practice) of 
its members, the failure modes identified, and any proposed risk mitigation strategies.   
 
The step-by-step FMEA analysis, conclusions, and rationale should be submitted to the FDA as 
part of any proposed proprietary name submission under the pilot program. 
 
8.  Nonprescription Drug Products Analysis  
 
The proposed proprietary names of nonprescription drug products (also known as over-the-
counter (OTC) drugs) submitted for approval under an NDA or ANDA are assessed prior to 
approval of the drug, as part of the review of the complete product labeling (see 21 CFR 
314.125(b)).   Consumer safety issues are given particular consideration in the labeling 
evaluation of these products.  Under the pilot program,  OTC product names should be assessed 
using the methods described in Sections 1-7 above, taking into account the following 
considerations. 
 
(cid:121)  OTC drugs are routinely selected and purchased by consumers and often recommended 
by name to consumers by a  healthcare practitioner. For these reasons, names for OTC 
drugs should be evaluated using simulation studies designed to test both consumer and 
healthcare professional understanding of proposed proprietary names. It may be 
important to evaluate whether participants can interpret written and oral communication 
of the name to safely select the proposed product. 
 
(cid:121)  FDA regulations (21 CFR 201.60, 201.61 and 201.62) outline the type of information 
that is required on the principal display panel of an OTC drug product. This information 
is important so the consumer can accurately self select and use the product, and as such, 
should not be misleading.   
 
(cid:121)  Although some packages may adhere to these regulations regarding the content of the 
principal display panel, in addition to the proprietary name, the presentation of 
information on the package may be inadequate and lead to consumer confusion, 
resulting in medication errors.  
 
(cid:121)  Concerns include, but are not limited to: information may be presented in a confusing 
manner; the package may lack necessary information for proper use; or there may be a 
failure to present the information so a consumer can differentiate the product from other 
similar products and use it correctly. 
 
(cid:121)  When a proprietary name is the name of a family of products, with multiple product 
names differing only by the suffix, it is even more important that the information on the 
principal display panel enable the consumer to differentiate products at the point of 
purchase.  Even distinguishing information elsewhere on the outer carton labeling may 
be overlooked.   
 
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(cid:121)  There are a number of examples to illustrate potential problems.  Companies have used 
the same proprietary name for single ingredient and combination products containing 
different active ingredients, or the same name for different combinations, causing 
consumers to purchase the wrong product.   
 
(cid:121)  FDA is also aware of consumer confusion resulting from  the use of proprietary names 
that differ only by the suffix attached to them  to designate a variety of  combination 
drug products, containing up to four ingredients (e.g., OURDRUG PM, OURDRUG. 
Cough and Cold formula.) When the same proprietary name is used for products 
containing different active ingredients, studies should be conducted to determine 
whether consumers are able to differentiate these products with the same proprietary 
name, with or without a suffix, based on the other information on the principal display 
panel.  
 
It is difficult to design a single study that could address all possible scenarios.  Thus, FDA 
encourages sponsors to meet with the Agency to discuss different protocols that could be used 
for their specific products prior to submission of the proposed proprietary name.  We recognize 
that the design of the studies may need to differ depending on the issues affecting a proposed 
product.   
 
The following general principles should be applied when testing a proprietary name of an OTC 
drug product in consumer and healthcare professional populations: 
  The evaluation should assess whether or not a proprietary name exaggerates the safety or 
effectiveness of the product or is otherwise confusing or misleading.  Aspects to consider  
include whether or not a proprietary name implies an indication or use,  active 
ingredient, dosing frequency, population, route of administration, and duration of effect 
that is inconsistent with the proposed dosing frequency, population, route of 
administration, and duration of effect of the product. 
  Evaluation questions should be nonleading and filter questions should be incorporated 
into the questionnaire (e.g. Does the name tell you what the product is used for?, yes 
or no.  If yes, what does it tell you it is used for?) 
 
B.  Promotional Review (Optional) 
 
The FDA evaluates proposed proprietary names to determine if they are overly fanciful, so as to 
misleadingly imply unique effectiveness or composition,  as well as to assess whether they 
contribute to overstatement of product efficacy, minimization of risk, broadening of product 
indications, or making of unsubstantiated superiority claims. See 21 U.S.C  321(n), 352(a) & 
(n); see also 21 CFR  201.10 (c)(3), 202.1(e)(5)(i) &(e)(6)(i).    
 
1.  Participation in the Promotional Review Element of the Pilot Program 
 
 
8455 FINALConcept Paper.doc 25    Concept Paper 
 
As previously noted, an applicant who chooses to participate in the pilot program may do so 
without submitting information regarding the promotional implications of its proposed 
proprietary name; pilot participation requires only the submission of safety review information.  
FDA will conduct its customary promotional review whether or not an applicant submits its own 
promotional review. Sponsors who choose to participate in the promotional review aspect of the 
proprietary name pilot program  may do so either (1) as part of an initial proposed proprietary 
name submission made under the pilot, or (2) as part of a response to FDAs rejection of a 
proposed proprietary name submitted under the pilot (where the initial submission addressed 
only safety review).   
 
2.   Evaluation 
 
 If an applicant chooses to conduct a promotional review, the promotional and safety reviews 
should be performed independently from one another so as to minimize bias in either review.  
The promotional review should focus on avoiding names that overstate product efficacy or 
safety, expand product indications, suggest superiority without substantiation, or that are of a 
fanciful nature that misleadingly implies unique effectiveness or composition .  It would be 
desirable for the promotional evaluation to involve personnel from marketing, regulatory affairs, 
social scientists with expertise in consumer psychology, and legal staff to determine whether a 
proposed proprietary name contains misleading implications.  The companys evaluation team 
should include persons versed in the regulations that govern prescription product advertising and 
promotion, with experience in the process of reviewing proposed promotional materials and 
proposed proprietary names.16  The analysis of sound empirical data, if available, should be 
given prominence in the evaluation of proposed proprietary names.   
 
To increase transparency and predictability in the review of proposed proprietary names from a 
promotional perspective, the FDA has proposed a quantitative evaluation method.  The design 
and methodology of studies used for this evaluation should be valid and reliable.  To facilitate 
collective evaluation at the end of the pilot program, it would be helpful for these studies also to 
use the same measures.  Although development of standardized, validated questionnaire 
measures (i.e., standard questions to be used across all studies) is thus desirable, it is beyond the 
17
scope of this concept paper.  One possible study methodology and some sample questions are 
included below.  These question samples are designed to guide sponsors in the development of 
outcome measures in their studies but are not intended to be an exhaustive list.  Sponsors are 
encouraged, but not required, to seek advisory comments from the Agency on their proposed 
study methodology, questionnaire, and analysis plan prior to data collection. 
 
3.  Research Methodology 
 
                                              
16  A companys internal process for selecting among potential names is not intended to be part of the submission. The 
companys submission should address only section B.3. Methodology. 
17
 
 Frameworks for designing a study to examine the potential promotional implications of proposed proprietary 
names are available.  See, for example, Whitley, Jr., B.E. (1996).  Principles of research in behavioral science.  
Mountain View, CA: Mayfield Publishing Company.  
 
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The FDA recommends an experimental approach to evaluate promotional implications of 
proposed names because this method enables interpretation of causal relationships between 
variables.  That is, by controlling all other experimental factors besides the drug name, 
researchers can be confident that the name itself caused particular responses.  Box 3 provides one 
possible approach for such an evaluation.  Other approaches may be appropriate. 
 
The approach described in Box 3 should be especially helpful in gathering information about 
how a name influences attitudes and behaviors of practicing healthcare practitioners.  If 
participants are only asked what they think about the proposed name, it will be difficult to 
determine how accurately their responses reflect their actual thoughts or likely behaviors because 
participants may state what they think they should state or what they think the investigators want 
to hear.  By comparing the responses to the proposed name with responses to the neutral control 
name, however, it could be determined whether the proposed name actually does influence these 
thoughts and intended behaviors.   
 
a.  Design of Questions 
 
A combination of open-ended and closed-ended questions, arranged from more general to more 
specific, should be used.  Questions should be designed so as to avoid leading questions, yea-
18
saying and other forms of bias.   Initial questions in the study should be asked before 
participants have any information about the product so that the answers will not be influenced by 
knowledge of product characteristics.  Subsequent questions would be asked after receiving 
indication information for the product but no other identifying information.  Because IND studies 
themselves form the basis of ultimate determinations about the efficacy and risk of a drug 
product seeking approval, the specifics may not be known at the time the proprietary name is 
proposed and undergoing testing.  Thus, there should be a measure of participant response when 
they have only minimal information.  
                                              
18 For a brief discussion of questionnaire bias in label comprehension studies, see Morris, L.A., Lechter, K., 
Weintraub, M., and Bowen, D. (1998).  Comprehension testing for OTC drug labels: Goals, methods, target 
population, and testing environment.  Journal of Public Policy and Marketing, 17(1), 86-96. 
 
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Box 3: Possible Evaluation Design 
The FDA proposes a crossover design in which the proposed proprietary name is evaluated in the context of both a 
neutral control name and an extreme control name.  This involves splitting the sample into two groups, both of whom 
will evaluate the proposed proprietary name but in a different order from each other. 
 
Before testing the proposed proprietary name, two control names should be established through pretesting: 
 
A neutral control name that is pretested to ensure that it makes no representations at all (i.e., it is neutral from a 
promotional standpoint) should be established.   
 
An extreme control name that is pretested to ensure it makes clear misrepresentations should be established 
 
The entire sample will respond first to questions about the neutral control name, described above.  Next, half of the 
sample responds to the proposed name and then to the extreme control name described above.  The other half of the 
sample responds to this extreme control name first and then to the proposed name.   
 
The study questions used as outcome measures should cover  perceptions elicited by the proposed name that are of a 
promotional nature (e.g., product safety, efficacy, indication, superiority), as well as questions designed to elicit 
aspects of behavioral intent (e.g., likelihood to prescribe).  The comparison of interest is participant responses to the 
proposed name compared with responses to the neutral control name.  The extreme name serves as a positive control 
to ensure that individuals can identify names that make representations about efficacy, safety or other promotional 
aspects.   
 
The FDA suggests that the neutral and extreme names be fictitious in nature to control for participants prior 
experience and attitudes.  Existing names could be acceptable as neutral or extreme controls if they are pretested and 
shown to possess the desired experimental qualities outlined above. 
 
Sponsors may choose to select different neutral and extreme control names for each study or they may choose to use 
the same neutral and extreme control names for multiple studies.   Respondents should be exposed to the neutral 
control name only once across studies: that is, sponsors that choose to use the same neutral name in more than one 
study should choose a new test sample for that study to ensure that participants have not previously responded to the 
neutral name.   
 
 
 
Examples of questions include:   
 
  You have just learned of a new product named DRUG X.  What, if anything, does the 
name DRUG X say or suggest to you about the product? (open-ended question) 
 
  Based on this name, which of these conditions do you think DRUG X treats? (please 
choose the best answer) (closed-ended question) 
    -  Condition 1 
    -  Condition 2 
    -  Condition 3 
    -  Condition 4 
 
  Based on this name, how effective or ineffective would you say DRUG X is? 
 
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    -  Very effective   
    -  Somewhat effective 
    -  Somewhat ineffective 
    -  Very ineffective 
 
  Based on this name, how safe or unsafe would you say DRUG X is? 
    -  Very safe   
    -  Somewhat safe 
    -  Somewhat unsafe 
    -  Very unsafe 
 
  Now you learn that the product DRUG X is used to treat CONDITION Y.  What does 
this name mean to you in this context? 
 
  Based on this name, how safe or unsafe would you say it is to use DRUG X to treat 
CONDITION Y? 
    -  Very safe   
    -  Somewhat safe 
    -  Somewhat unsafe 
    -  Very unsafe 
 
  Based on this name, how effective or ineffective would you say DRUG X is to treat 
CONDITION Y? 
    -  Very effective   
    -  Somewhat effective 
    -  Somewhat ineffective 
    -  Very ineffective 
 
  If DRUG X were available, how likely would you be to prescribe DRUG X for 
CONDITION Y? 
-  Not at all likely 
-  Somewhat likely 
-  Moderately likely 
-  Very likely 
 
  On a scale from 1 to 5 where 1 equals Strongly Disagree and 5 equals Strongly Agree, 
please indicate your agreement or disagreement with the following statement: 
 
This name makes superiority claims over other products with the same indication. 
 
b.  Sampling 
 
Note: these are general comments.  A statistician should be consulted before making definitive 
determinations about sample size and sampling design.  The size of the sample should be 
adequate to detect differences.  The sample should represent the relevant prescribing population 
 
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and be generalizable to this population.  In addition, applicants should also consider testing a 
sample of consumers.  Although this group does not have prescribing authority, consumers 
should and do participate actively in treatment decisions.  The product name may play a role here 
through direct-to-consumer (DTC) advertising.   
 
c.  Submission to FDA 
 
Sponsors choosing to participate in the promotional review component of the pilot program 
should submit to the appropriate center for evaluation all research methodology used to support a 
proposed proprietary name. This includes a description of participant demographics; the product 
profile provided to study participants; the complete study questionnaire; the coding scheme used 
to analyze open-ended questions; complete study results (both positive and negative), including 
results of pretests; and  any other information given to the study participants regarding the drug 
approval process (e.g., copies of FDA regulations given to study participants).   
 
 
V.  WHAT WILL FDA CONSIDER WHEN EVALUATING PILOT SUBMISSIONS?  
 
This section describes the kinds of things the FDA will consider as it reviews manufacturers' 
submissions as part of the pilot program.   
 
A.  Standards  
 
The ultimate goal of FDA's safety review of a proposed proprietary name is avoiding medication 
errors. The FDA will evaluate the safety and promotional implications of a name under the pilot 
program using the same methods the Agency currently uses to evaluate proposed proprietary 
names.  If a proprietary name demonstrates vulnerability to confusion in the testing stage, the 
FDA will not recommend its approval for use in the market and will request the applicant 
propose an alternate name for evaluation.  There is no apparent health benefit from using one 
name rather than another.  From a public health perspective, then, any preventable risk of 
medication error that can be identified prior to drug approval should be addressed by selection of 
an alternative name if necessary and sufficient to avoid similar risk..  The FDA will examine 
both the process used and the reasoning and conclusions reached in an applicants determination 
that the name it puts forth is safe, and, if addressed by the applicant, that the name does not have 
impermissible promotional implications. 
 
B.  Assessing the Data, Methods, and Evaluation 
 
Under the pilot program, the FDA will assess the adequacy of the data collected and submitted to 
support the safety and promotional analysis, including any data derived from alternative 
methods.  We will also identify medication error safety concerns that will need attention prior to 
approval.  Because the FDA will also evaluate the safety and promotional aspects of the 
proposed name using our traditional proposed drug name review, we intend to evaluate and 
document the differences in the data, findings, and conclusions between the centers and 
applicants analyses and reviews. 
 
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At the end of the pilot, FDA will evaluate the results to determine if the methods described in 
this paper are reliable, if methods should be changed or added, and if the model of industry 
conducting reviews, submitting the results to FDA, and FDA reviewing the data would be a 
better model than the current model. FDA will present these findings in a public meeting in FY 
2013 or before. 
 
As a general guide, we plan to consider the following:  
 
1.  Did the applicant screen the proposed name with regard to the common errors listed 
previously (Box 1) to ensure acceptability for testing? 
2.  Did the applicant confirm that the proposed name does not contain a USAN stem; was the 
date of the search included? 
3.  Did the applicant conduct a thorough database search to identify existing similar names, 
using, at a minimum, those publicly available databases described in Appendix A?  Was the 
search methodology adequately described, and were all resulting similar names documented?  
4.  Did the applicant use appropriate computational methods to identify additional look-alike 
and sound-alike names?  Were the parameters adequately described? 
5.  Did the applicant consider all available medication error data related to the proposed 
proprietary name (e.g. for products with the same active ingredient marketed domestically or 
internationally)?   
6.  Did the applicant conduct a name simulation study that reflected all relevant real-use 
conditions (e.g., inpatient/outpatient, written/spoken)?  Were all resulting qualitative and 
quantitative data from the simulation provided in addition to a clear description of the testing 
protocol?  Was the appropriate range of practitioners included in the testing? 
7.  Was the composition of the FMEA team appropriate with respect to the number of people, 
healthcare expertise, and medication error experience? Was the FMEA analysis thorough and 
well-structured (e.g., were all relevant failure modes and associated effects identified, did the 
analysis consider all potential practice use settings, were product characteristics beyond the 
proprietary name considered)? 
8.  If alternate or additional testing methods were used,  were these well described and 
documented? 
 
C.  Increasing transparency 
 
Although one objective of the pilot program is to increase transparency of the name evaluation 
and FDA review processes, in some cases FDA has access to information that is not publicly 
available to applicants.  The FDA will communicate with the applicant to the extent  permitted 
by law to describe the nature of this information.  Some examples of situations where FDA may 
have information that influences its assessment but was not known to applicants include: 
 
  Other names are in the review pipeline that, in the Agencys view, may cause confusion 
or possible medication error.  Under FDA's regulations, information in an unapproved 
 
8455 FINALConcept Paper.doc 31    Concept Paper 
 
application, including proposed proprietary names, is generally not publicly available 
(see 21 CFR   312.130, 314.430, 601.50 & 601.51). 
  FDA is aware of postmarket experience or error risks that the applicant may have 
overlooked or to which the applicant did not have access. 
 
 
 
 
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APPENDIX A:  COMPUTERIZED RESOURCES 
 
In most cases, the computerized resources listed here are publicly available.  
 
Adverse Events Reporting System (AERS) 
 
AERS is a database application in CDER that contains adverse event reports for approved drug 
products and therapeutic biologics.  Manufacturers, for example, are required to send adverse 
event reports to FDA as specified in FDA regulations, and healthcare professionals and 
consumers are encouraged to voluntarily report possible errors to the FDA. The main utility of 
such a spontaneous reporting system is to identify potential postmarket safety issues.  There are 
inherent limitations to this system, however.  For example, there is underreporting and duplicate 
reporting; information received may be incomplete; for any given report, there is no certainty 
that the reported suspect product(s) caused the reported adverse event(s); and raw counts from 
AERS cannot be used to calculate incidence rates or estimates of drug risk for a particular 
product or used for comparing risk between products.  
 
Vaccine Adverse Event Reporting System (VAERS)  
 
VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and 
Prevention (CDC) and FDA (CBER).  VAERS is a postmarket safety surveillance program, 
collecting information about adverse events that occur after the administration of U.S. licensed 
vaccines.  The VAERS Web site provides a nationwide mechanism by which adverse events 
following immunization can be reported, analyzed, and made available to the public. The 
VAERS Web site also provides a vehicle for disseminating vaccine safety-related information to 
parents/guardians, healthcare practitioners, vaccine manufacturers, state vaccine programs, and 
other constituencies.  The majority of VAERS reports are sent in by vaccine manufacturers and 
healthcare practitioners.  However, these data are subject to limitations such as underreporting, 
simultaneous administration of multiple vaccine antigens (making it difficult to know to which 
of the vaccines, if any, the event might be attributed), reporting bias, and lack of incidence rates 
in unvaccinated comparison groups.  When evaluating data from VAERS, it is important to note 
that for any reported event, no cause and effect relationship has been established.  The report of 
an adverse event to VAERS is not documentation that a vaccine caused the event.  
 
Micromedex Integrated Index  
 
This reference contains a variety of databases covering pharmacology, therapeutics, toxicology, 
and diagnostics.  This information may be useful for naming because it contains a large number 
of product names marketed both domestically and abroad. 
 
Phonological and Orthographic Computer Analysis (POCA) 
 
This application was designed by the FDA.  As part of the name similarity assessment, proposed 
names are evaluated via a phonological/orthographic algorithm.  The proposed proprietary name 
is converted into its phonemic representation before it runs through the phonological algorithm.  
Likewise, an orthographic algorithm exists that operates in a similar fashion.  The source code 
 
8455 FINALConcept Paper.doc 33    Concept Paper 
 
and supporting technical documentation for this tool will be available for public use by the end 
of FY 2008. 
 
Drug Facts and Comparisons, online version, St. Louis, MO  
 
Drug Facts and Comparisons, a part of Wolters Kluwer Health, is a compendium developed for 
health professionals.  The compendium is organized by therapeutic class; contains monographs 
on prescription and nonprescription products, with charts comparing similar products.  
(http://online.factsandcomparisons.com/index.aspx?)  
 
Drugs@FDA 
 
Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/) is an FDA Web site that 
catalogs most of the drug products approved in the United States since 1939.  The majority of 
labels, approval letters, reviews, and other information are available for drug products approved 
from 1998 to the present.  Drugs@FDA contains information about FDA-approved brand name 
and generic drugs and therapeutic biological products prescription and over-the-counter human 
drugs and therapeutic biologicals, and discontinued drugs. 
 
CBER Products 
 
The CBER Products Web site catalogs most of the biologic products currently reviewed by 
CBER.  Many of the labels, approval letters, reviews, and other information are available for 
products approved from 1996 to the present (http://www.fda.gov/cber/products.htm). 
 
 Electronic online version of the FDA Orange Book  
 
This Web site provides a compilation of approved drug products with therapeutic equivalence 
evaluations  (http://www.fda.gov/cder/ob/default.htm). 
 
United States Patent and Trademark Office 
 
This Web site provides information regarding marketed and pending patents and trademarks  
(http://www.uspto.gov). 
 
Clinical Pharmacology Online  
 
This resource, provided by Thomson & Thomsons SAEGIS TM Online Service, contains full 
monographs for the most common drugs in clinical use, plus mini monographs covering 
investigational, less common, combination, nutraceutical and nutritional products.  It provides a 
keyword search engine (www.thomson-thomson.com). 
 
The Pharma In-Use Search Database  
 
 
8455 FINALConcept Paper.doc 34    Concept Paper 
 
This database contains more than 400,000 unique pharmaceutical trademarks and trade names 
that are used in about 50 countries worldwide. The data are provided under license by IMS 
HEALTH.   
 
Natural Medicines Comprehensive Databases  
 
This Web site contains up-to-date clinical data on the natural medicines, herbal medicines, and 
dietary supplements used in the western world.  (http://www.naturaldatabase.com) 
 
Stat!Ref  
 
STAT!Ref, is a subscription-based, online medical reference library that contains full-text 
information from approximately 30 texts, including tables and references.  Among the database 
titles are: Handbook of Adverse Drug Interactions, Rudolphs Pediatrics, Basic Clinical 
Pharmacology and Dictionary of Medical Acronyms Abbreviations.  (http://www.statref.com) 
 
USAN Stems  
 
The USAN Council (tri-sponsored by the American Medical Association (AMA), the United 
States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA), 
aims for global standardization and unification of drug nomenclature and related rules to ensure 
that drug information is communicated accurately and unambiguously, working closely with 
the International Nonproprietary Name (INN) Programme of the World Health Organization 
(WHO), and various national nomenclature groups.  This Web site, managed by the AMA, 
contains lists of all of the recognized USAN stems.   
(http://www.ama-assn.org/ama/pub/category/4782.html) 
 
Red Book Pharmacys Fundamental Reference 
 
This reference contains prices and product information for prescription, over-the-counter drugs, 
medical devices, and accessories.  
 
Medical Abbreviations Book 
 
Various references on this topic are available.  These references contain commonly-used medical 
abbreviations and their definitions. 
 
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APPENDIX B:   PROPOSED TEMPLATE FOR A PILOT PROGRAM 
SUBMISSION 
 
I.  Table of Contents 
II.  Executive Summary 
Provide a summary of the overall findings of the proprietary name review including the 
rationale as to why the name is acceptable. 
III.  Introduction 
a.  Identify the primary and alternate proprietary name(s). 
b.  Provide information to support the FDAs traditional name review19 and/or 
provide the container label, carton labeling, and professional insert in an 
Appendix. 
IV.  Safety Review 
a.  Preliminary Screening 
Describe the methods used and considerations given to the proprietary name in 
the prescreening process.  If a proposed name fails the preliminary screening and 
is submitted to the FDA for evaluation, describe the rational for pursuing the 
name. 
b.  USAN Stem Search 
Include a statement that indicates the name(s) does not contain a USAN stem 
along with the date on which this information was searched on the USAN list. 
c.  Orthographic and Phonological Similarities 
Provide the following information: .  
  All search queries 
  The system parameters used for each search (e.g., letter substitution) 
  The precise databases searched 
  Any thresholds imposed on the output (e.g., top 100, top 200, etc.) 
  The date the search was conducted or the last update of the database that was 
searched 
  Pooled results with source citation and full product characteristics of each 
name identified as a possible source of confusion with the proposed name. 
 
                                              
19 FDA is developing guidance on the content of a complete submission for the evaluation of proprietary names. 
 
8455 FINALConcept Paper.doc 36    Concept Paper 
 
 Note:  Although such searches generate many names that may be ruled out 
under further analysis, we request that all names initially identified as a potential 
source of confusion be submitted.  
 
d.   Computational Methods 
 
Provide the following information on the computational method(s) used: 
 
  The measure of similarity/distance used 
  The values assigned to any adjustable parameters 
  The manner in which non-name attributes (e.g., strength, dosage form, route 
of administration) were handled 
  If a weighting scheme was used, describe how the different elements were 
weighted 
  The precise database searched (e.g., Orange Book, including or excluding 
discontinued products, USPTO (what class), Multum Lexicon). 
  If a cutoff or threshold was used to narrow or widen the search results, the 
cutoff or threshold, and how and why it was chosen 
  Testing output 
 
e.  Medication Error Data  
If your proposed product contains an active ingredient that is marketed 
domestically or abroad, all available information relevant to medication error 
cases associated with that active ingredient should be identified and submitted to 
the FDA.  Relevant information would include any error reports related to the 
product nomenclature, active ingredient, package, and/or the label and labeling.  
This information should be identified and reported to the FDA in line listings with 
a narrative as described in the box below.  
 
Format for Submitting Relevant Information 
 
  The FDA recommends that applicants submit a line listing and narratives of the medication error 
case reports identified in the postmarket period for marketed products with the same active 
ingredient as the product under review. 
  The applicant should cite the source of the report along with any analysis conducted by the 
applicant.  Applicants should submit the full text of any article published on medication errors 
associated with the product.   
  Applicants should also categorize these errors by type (e.g., incorrect product, incorrect route of 
administration) using the NCC MERP taxonomy.   
  Applicants should review these cases to identify factors that contributed to the medication errors 
and to ascertain whether these risks apply to the proposed proprietary product name.  All 
medication error data should be integrated into the FMEA. 
 
 
8455 FINALConcept Paper.doc 37    Concept Paper 
 
f.  Name Simulation Studies 
Describe all methodology associated with the simulation study including but not 
limited to how participants were chosen and the composition and qualifications of 
participants. 
g.  Failure Mode and Effects Analysis 
Provide the relevant information to demonstrate that the name will not lead to 
confusion.  Describe the methods associated with the FMEA (how the team was 
chosen, the composition of the team, qualification of its members, the failure 
modes identified, and any proposed risk mitigation strategies).   
V.  Promotional Review (if applicant chooses to participate in this aspect of pilot) 
Describe all research methodology used to support a proposed proprietary name,  including a 
description of participant demographics; the product profile provided to the study participants; 
the complete survey questionnaire;  the coding scheme used to analyze open-ended questions; 
complete results (both positive and negative), including results of pretests; and any other 
information given to the study participants regarding the drug approval process and the 
regulations regarding proprietary names.  
 
VI.  Alternative Methods 
If the methods used to assess the proposed proprietary name differ from those suggested in the 
concept paper for the PDUFA Pilot Project - Proprietary Name Review, submit the rationale for 
deviation, a full description of the methods, and all data generated and any analysis of this data 
from the alternative test method(s). 
 
 
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