PDUFA PILOT 

PROJECT

PROPRIETARY NAME REVIEW 

CONCEPT PAPER 

September 2008 

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 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 PROGRAM—LOGISTICS................................................................................................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

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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; 

monitoring; and use.”

3

 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 

poorly designed packaging.4 In the U.S. healthcare system, healthcare practitioners rely on a 

product’s 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 practitioner’s 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 

provided), and outputs (effective, efficient, and safe treatment).6 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 FDA’s 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 Agency’s’ 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 PROGRAM—LOGISTICS 

As outlined above, one of FDA’s 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 FDA’s 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 FDA’s 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 presubmission 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 FDA’s 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 applicant’s 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 applicant’s 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 FDA’s 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 applicant’s 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 applicant’s analysis and from the 

FDA’s 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 applicant’s evaluation and 

FDA’s 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 firstchoice 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 applicant’s analysis in addition to conducting its own analysis using the traditional 

approach. Although the FDA would ideally review the applicant’s 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. 

FDA’s 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 

FDA’s 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 FDA’s 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. 
 Concept Paper 

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 FDA’s 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 

similarity 

Potential causes of 

product name 

similarity 

Attributes examined to 

identify similar product 

names 

Potential Effects 

Similar spelling Identical prefix 

Identical infix 

Identical suffix 

Length of the name 

Overlapping product 

characteristics 

Names may appear similar in 

print or electronic media and lead 

to product name confusion in 

printed or electronic 

communication 

Names may look similar when 

scripted and lead to product name 

confusion in written 

communication 

Look-alike 

Orthographic 

similarity 

Similar spelling 

Length of the name 

Upstrokes 

Downstrokes 

Cross-stokes 

Dotted letters 

Ambiguity introduced by 

scripting letters 

Overlapping product 

characteristics 

Names may look similar when 

scripted, and lead to product 

name confusion in written 

communication 

Sound-alike Phonological 

similarity 

Identical prefix 

Identical infix 

Identical suffix 

Number of syllables 

Stresses 

Placement of vowel sounds 

Placement of consonant 

sounds 

Overlapping product 

characteristics 

Names may sound similar when 

pronounced and lead to product 

name confusion in spoken 

communication 

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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required to detect an error rate of 0.001 at the 0.05 significance level12). 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., physician—ward clerk—pharmacist—nurse). 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., physician—pharmacist). 

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 applicant’s 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 applicant’s pronunciation is Kuh-lee-tra). 

 

Table 2: 

Example Scenarios for Name Simulation Study for an Orally Administered Drug 

Scenario 

Number 

Prescribing Condition Participant Group 

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 

written order unaided pronunciation 

physician D – nurse I - ward clerk D –

pharmacist E – nurse J 

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Table 2: 

Example Scenarios for Name Simulation Study for an Orally Administered Drug 

Scenario 

Number 

Prescribing Condition Participant Group 

6 Inpatient: Spoken order transcribed to a 

written order unaided pronunciation 

physician assistant B – nurse K - ward clerk E 

– pharmacist F – nurse L 

7 Inpatient: Spoken order transcribed to a 

written order pronunciation as intended by 

applicant 

physician E – nurse M – pharmacist G – nurse 

N 

8 Inpatient: Spoken order transcribed to a 

written order pronunciation as intended by 

applicant 

physician F – nurse O - ward clerk F –

pharmacist H – nurse P 

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 

voice mail unaided pronunciation 

nurse practitioner C - pharmacist Q 

18 Outpatient: Spoken prescription left on 

voice mail unaided pronunciation 

physician K - pharmacist R 

19 Outpatient: Spoken prescription left on 

voice mail pronunciation as intended by 

applicant 

nurse practitioner D - pharmacist S 

20 Outpatient: Spoken prescription left on 

voice mail pronunciation as intended by 

applicant 

nurse practitioner E – pharmacist T 

21 Outpatient: Electronic generated 

prescription 

physician L – pharmacist U 

22 Outpatient: Electronic generated 

prescription 

physician M – pharmacy technician A – 

pharmacist V 

23 Outpatient: Electronic generated 

prescription 

physician assistant E – pharmacist W 

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 

any other drug name? 

If yes which drug? 

Yes 

No 

Brand X 

Brand Y 

8 

52 

3 

5 

Do you think this name sounds like 

any other drug name? 

If yes, which drug? 

Yes 

No 

Brand X 

8 

52 

8 

Do you think this name looks like 

any medical terms or laboratory 

tests? 

If yes, what terms or tests? 

Yes 

No 

0 

60 

Do you think this name sounds like 

any medical terms or laboratory 

tests? 

If yes, what terms or tests? 

Yes 

No 

0 

60 

Describe your overall impression of 

the name. These comments do not 

necessarily have to be related to 

safety. 

There are many drug names on 

the market that seem to start 

with ___. 

Good name does not appear to 

be a problem 

The name seems to conflict with 

what the drug is suppose to treat 

12 

35 

13 

Transparency of the study process is essential. Applicants should submit, and the FDA will 

review, all methodology associated with the simulation study—including 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 FDA’s 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-thecounter (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. 

y 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. 

y 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. 

y 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. 

y 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. 

y 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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y 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. 

y 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 

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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 FDA’s 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 company’s 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 

scope of this concept paper.

17

 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 company’s internal process for selecting among potential names is not intended to be part of the submission. The 

company’s 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, yeasaying and other forms of bias.18 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 applicant’s 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 center’s and 

applicant’s 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 Agency’s view, may cause confusion 

or possible medication error. Under FDA's regulations, information in an unapproved 

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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 

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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 & Thomson’s 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 

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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, Rudolph’s 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 Pharmacy’s 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 FDA’s 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. 

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 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. 

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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).