
[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Notices]
[Pages 28706-28710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14212]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0648]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; PDUFA Pilot Project 
Proprietary Name Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the collection of information by July 
17, 2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
the title ``PDUFA Pilot Project Proprietary Name Review.'' Also include 
the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

[[Page 28707]]


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

PDUFA Pilot Project Proprietary Name Review

    In the Federal Register of October 7, 2008 (73 FR 58604), FDA 
announced the availability of a concept paper entitled ``PDUFA Pilot 
Project Proprietary Name Review.'' The concept paper describes how 
pharmaceutical firms may evaluate proposed proprietary names and submit 
the data generated from those evaluations to FDA for review under a 
pilot program to begin by the end of fiscal year (FY) 2009.
    On September 27, 2007, the President signed into law the Food and 
Drug Administration Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 
823), which includes the reauthorization and expansion of the 
Prescription Drug User Fee Act (PDUFA IV). As part of the 
reauthorization of PDUFA IV, FDA committed to certain performance 
goals, including the goal of using user fees to implement various 
measures to reduce, among other things, medication errors related to 
look-alike and sound-alike product proprietary names. FDA also agreed 
to develop and implement a voluntary 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. The concept paper is intended to 
help pharmaceutical firms choose appropriate proprietary names for 
their drug and biological products before submitting marketing 
applications to FDA and describes how pharmaceutical firms may use 
``best practices'' to carry out their own proprietary name reviews and 
provide FDA with the data that result from those reviews. The goals of 
the concept paper and the voluntary pilot program are to minimize the 
use of names that are misleading or that are likely to lead to 
medication errors, to make FDA's marketing application review more 
efficient, and to make regulatory decisions more transparent. The 
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 marketing application approval and 
subsequent marketing of a drug or biological product in the United 
States, and how to submit the results of the assessment for review 
under the pilot program.
    The information described in the concept paper and the data 
collected may not be submitted to FDA until OMB has approved the 
information collection associated with the pilot program. After OMB 
approval, FDA will accept requests to register for the pilot program. 
FDA will announce OMB's approval and other details on participating in 
the pilot program in the Federal Register. FDA expects that the pilot 
program will begin by the end of FY 2009.
    The information collection that will result from the voluntary 
pilot program, as described in the concept paper, consists of the 
following:
    1. Applicants should contact FDA to register and indicate the 
approximate date of their proprietary name submission, as described in 
the concept paper and as will be described in more detail when FDA 
announces OMB's approval and the specific information on participating 
in the pilot program.
    2. Applicants should contact the appropriate FDA center 120 days 
prior to the intended date of the proposed proprietary name submission 
to discuss the specific details of the planned submission. Applicants 
should communicate with the Director in the Division of Medication 
Error Prevention and Analysis in the Office of Surveillance and 
Epidemiology in the Center for Drug Evaluation and Research, or the 
Branch Chief at the Advertising and Promotion Labeling Branch of the 
Division of Case Management in the Office of Compliance and Biologics 
Quality in the Center for Biologics Evaluation and Research, concerning 
any questions about their proposed submissions. For prescription 
products, applicants should inform the appropriate center at the 120-
day pre-submission discussion if they plan to use alternative or 
additional methods to evaluate the safety of their proposed proprietary 
name. For nonprescription products, sponsors should discuss with FDA 
different protocols that could be used for their specific drug products 
prior to the submission of the proprietary name.
    3. Applicants should submit two separate sets of product name-
related information to enable parallel reviews by FDA as follows: (a) A 
comprehensive evaluation of the proposed proprietary name including the 
information and data listed in Appendix B (``Proposed Template For A 
Pilot Program Submission'') of the concept paper; and (b) the 
proprietary name information that they would ordinarily submit under 
FDA's current practice. (Note: The proprietary name information 
ordinarily submitted under FDA's current practice is not included in 
the estimates in table 1 of this document because this information 
collection is already approved under OMB Control Numbers 0910-0001 and 
0910-0338).
    4. After review of the proprietary name submissions, and if FDA 
informs the applicant that the proposed first-choice proprietary name 
is unacceptable, the applicant should confirm in writing that it would 
like its originally submitted second-choice name reviewed, or the 
applicant should submit an alternative second-choice name along with 
the information described in the concept paper. At that time, FDA will 
begin review of the second-choice name. 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 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.

Comment and Related Issues

    In the Federal Register of December 23, 2008 (73 FR 78813), FDA 
published a 60-day notice requesting comments on the information 
collection. We received one comment, which raised the following issues:
    1. The comment stated that the focus of the Pilot Program should be 
on safety evaluations for drug products that will be marketed in the 
United States. The comment said that trademark clearance from both the 
legal and regulatory perspectives is often conducted by sponsors to 
support the geographic markets for the product and therefore often 
extends beyond the United States. The comment said it is not uncommon 
for pharmaceutical companies to develop trademarks that will be granted 
registrations from trademark offices in connection with approvals from 
health authorities in multiple countries with the goal of becoming 
global trademarks. Except for product names in foreign markets that are 
identical to the trademark under review, the comment recommended that 
FDA limit its requests for search data to clearance activities relating 
to trademarks that are in use or appear likely from public sources to 
be in use in the near future in the United States. The comment said 
that data from outside the United States can be voluminous and are not 
necessary for the proper performance of FDA's functions or for 
determining the

[[Page 28708]]

appropriateness of the name in the United States.
    The comment also expressed concern with ``FDA's proposed broad 
request for trademark search-related information insofar as they apply 
to all search queries.'' (The comment referenced bullet points on pages 
14 and 36 of the concept paper). The comment said that FDA 
underestimates the burden of collecting such information. At the early 
stages of trademark clearance, the comment noted that a sponsor 
generally begins with a list that could include hundreds of candidates, 
and that this list is typically narrowed in successive waves of more 
in-depth searches of candidates based on legal and regulatory concerns. 
The comment said that because a sponsor cannot determine in advance 
which of the candidates on the initial list will survive the clearance 
process, sponsors would have to maintain the records of the early-
stage, en masse searches relating to possibly hundreds of names on the 
list to comply with a request for all search queries. The comment said 
that sponsors should not be expected to maintain search query 
information for en masse search investigations on name candidates, 
especially those which had been eliminated previously and well before 
submission to FDA as proposed trademarks. It also asserted companies' 
entitlement to maintain applicable legal privileges for information and 
communications developed in the course of trademark availability 
assessment.
    2. The comment also said that medication errors can be caused by 
any number of system failures or other causes at any one or more stages 
in the process of prescribing, dispensing, and administering 
medications, and that medication errors are the result of multiple 
causes. The comment said that there is no scientifically valid and 
reliable method for measuring the extent to which pharmaceutical 
proprietary names might contribute to the risk of such errors or 
whether such methods could ever adequately take into account the 
subjectivity and complexity of human perception. It also stated that 
the agency's proprietary name review process must be guided by the 
first amendment.
    3. The comment noted that the burden of the collection of 
information should be minimized by using various automated collection 
techniques and other forms of information technology, and referred to 
the computerized databases listed in Attachment A of the concept paper. 
The comment said that some of the databases listed have limited value 
because they are substantially redundant with the collective content of 
the remaining databases, are not amenable to automated searching, or 
have more limited automated searching capabilities than others. The 
comment also noted that some sponsors may not have the resources to 
subscribe to many databases and will have to rely on the search 
capabilities of vendors, and questioned whether vendors that offer 
search services include all of the sources listed on Attachment A of 
the concept paper.

FDA Response

    To evaluate the proposed information collection, FDA believes it is 
important to recall that the information collection not only supports 
the agency's statutory mandates to ensure that drugs are safe and 
effective and are not misbranded, but also that it is part of a 
voluntary pilot program intended to make FDA's regulatory decisions 
more transparent and to explore ways to make FDA's application review 
more efficient. As indicated in the concept paper, FDA committed to 
this program in conjunction with the reauthorization of PDUFA IV, after 
extensive discussion with industry, to support the goals of reducing 
medication errors related to look-alike and sound-alike proprietary 
names, unclear label abbreviations, acronyms, dose designations, and 
error-prone label and packaging designs.
    The pilot program is intended not only to minimize the use of names 
that are misleading or that are likely to lead to medication errors, 
but also to provide a basis for FDA to determine whether in the future, 
it would be feasible and preferable for FDA to achieve these goals 
through review of analyses of proprietary names conducted and submitted 
by applicants, as many applicants have suggested, rather than 
conducting its own analyses, as is the current practice. To this end, 
the proposed information collection recommended in the pilot program is 
largely modeled on the information that FDA itself currently generates 
and analyzes in evaluating proposed proprietary names, in accordance 
with its statutory authorities and the first amendment. FDA requests 
that these elements be submitted by pilot program participants because 
of its own direct experience supporting the utility of such 
information, but as the pilot program concept paper makes clear, 
applicants can still participate in the pilot program if they plan to 
deviate from the proposed proprietary name safety evaluation methods 
recommended in the concept paper and instead use alternative or 
additional methods. Also, to the extent that the comment also suggests 
that the information collection for the pilot program should also be 
limited to information related to safety concerns, we note that 
applicants can participate in the pilot program without submitting any 
information to evaluate the promotional implications of their proposed 
proprietary names.

With Regard to the Specific Elements of the Comment

    1. FDA does not seek to expand the burden of collecting trademark 
search-related information, and is not requesting that sponsors submit 
broad trademark search queries or other search-related screening 
information about any preliminary or early-stage proprietary name 
candidates which the sponsor eliminated from consideration and 
therefore did not submit to FDA for review as part of the proprietary 
name pilot program.
    FDA is interested in collecting all search queries that are 
specific to the proposed proprietary name a sponsor submits to the 
pilot program for review, including all existing, publicly available 
drug names initially identified as a potential source of confusion with 
respect to the proposed name. Specifically, FDA requests that a sponsor 
submit all of the search queries that were generated only for the 
specific proposed proprietary name submitted to FDA. For each query, 
the results are dependent upon how each data source was searched.
    Thus, in order for FDA to evaluate the strength of the results, 
information pertaining to each query, such as--the system parameters 
that were used for each search; the precise databases that were 
searched; any thresholds imposed on the output; the date the search was 
conducted or the last update of the database searched; the pooled 
results with source citation and full product characteristics of each 
name identified as a possible source of confusion with the proposed 
name--should be provided on the proposed name submitted to FDA for 
evaluation. Providing FDA with all of the search queries relevant to 
the proposed name and associated tests, including the Failure Mode and 
Effects Analysis, will permit FDA to understand and evaluate the basis 
for the sponsor's conclusions that existing drug names that are 
identical or potentially similar to the proposed proprietary name would 
not be likely to cause confusion and medication errors. By submitting 
this information, the sponsor would be supporting the goals of the 
concept paper and the voluntary pilot program.

[[Page 28709]]

Such goals include not only minimizing the use of names that are 
misleading or that are likely to lead to medication errors in the 
clinical setting (due to look-alike and sound-alike proprietary names), 
but also include allowing FDA to evaluate whether to have applicants 
perform their own name analysis and submit resulting data to FDA for 
review.
    At the conclusion of the pilot program, FDA will be evaluating what 
information would be most useful as the basis of those industry-
conducted proprietary name reviews. These evaluations will be largely 
qualitative. The results of the pilot program and recommended additions 
and changes to methods based on the reported results will be discussed 
in a future public meeting. With regard to the comment addressing legal 
privilege related to trademark evaluations, as noted previously, 
applicants can participate in the voluntary pilot program even if they 
deviate from the proposed proprietary name safety evaluation methods 
recommended in the concept paper, and therefore may determine for 
themselves how to submit useful information without compromising legal 
privileges related to trademark.
    FDA also acknowledges that ``search data'' for trademark clearance 
activities collected from outside the United States can be voluminous, 
particularly if sponsors are seeking to register a single global 
trademark for their drug in multiple countries. As already indicated 
FDA is not seeking broad trademark clearance search data but is 
interested in information specifically relevant to assessing the 
potential for medication error related to the specific proprietary name 
proposed for the United States. For this purpose, FDA agrees that the 
most relevant information includes information identifying product 
names in foreign markets that are identical to the name proposed for 
the U.S. market, regardless of active ingredient or other product 
characteristic.
    In addition, FDA agrees that it is important to collect information 
regarding phonological or orthographic similarities between the 
proposed name and foreign drug names that are in use or appear likely 
from public sources to be in use in the near future in the United 
States; such names should be considered in the same way as the names of 
any other drug products also in use in the United States.
    FDA believes that in certain circumstances, however, it is in the 
interest of public health for sponsors to provide the agency with other 
data that they may possess that indicates close similarities in 
spelling and pronunciation between the proprietary name proposed for 
the U.S. and foreign drug names. For example, patients in the United 
States may experience medication errors related to confusion of the 
names of a drug marketed in the United States and one obtained from a 
foreign country, either while the patient was abroad or through other 
means, whether or not the foreign drug is intended for the U.S. market 
by the manufacturer. This potential situation presents a particular 
public health risk where a drug product is currently marketed in a 
foreign country under a proprietary name which is identical or very 
similar to the proposed proprietary drug name under FDA review, but the 
drugs contain a different active ingredient. FDA therefore believes it 
is useful and supportive of the agency's drug safety mandates to 
encourage the submission of such data in the pilot program.
    2. Concerning the comment that there is no scientifically valid and 
reliable method for measuring the extent to which pharmaceutical 
proprietary names might contribute to the risk of medication errors, 
FDA agrees that medication errors can be caused by any number of system 
failures or other contributing factors at any one or more stages in the 
medication use system, and that medication errors may be the result of 
multiple causes, many of which are not easily controllable. However, 
proprietary product names have been widely recognized as one important 
contributing source of medication errors, and one that is amenable to 
control. 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. Although review of 
proprietary names will not eliminate all medication errors, it can help 
reduce the risk of such errors by identifying and eliminating a 
contributing factor prior to drug approval. The Institute of Medicine 
(IOM) has repeatedly recognized that medication use errors may occur 
due to sound-alike or look-alike names, unclear labels, or poorly 
designed packaging and are pivotal causes of these system-wide problems 
(To Err is Human--Building a Safer Health System (2000) and Preventing 
Medication Errors (2006)). (See section II.A. of the concept paper for 
a brief summary of pertinent IOM conclusions). In 2007 Congress 
responded to these IOM findings, and as part of the reauthorization of 
PDUFA IV, mandated FDA's collection and use of user fees for, among 
other things, the review of drug applications and drug safety 
activities, in support of which FDA committed to meet performance 
goals, several of which highlighted the importance of considering 
proprietary names as a potential source of medication errors. These 
PDUFA IV goals, communicated to Congress, include FDA's commitment to 
implement this pilot program as one measure to help reduce medication 
errors related to look-alike and sound-alike proprietary names.
    FDA has acknowledged in three public meetings on proprietary drug 
review (held in June 2003, December 2003, and June 2008) that there is 
no gold standard for testing proprietary drug product names to assess 
the risk of medication error. At the public technical meeting held in 
June 2008, topics included subsequent review of 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 prescription and nonprescription products, and in the 
absence of a gold standard, the elements of best practices in testing. 
At the June 2008 public meeting, all of the proposed evaluation methods 
were judged by individual experts participating in the public meeting 
to be complementary and were considered to offer value in the name 
testing process. As discussed in section IV of the concept paper, in 
the absence of a gold standard, FDA emphasizes that the best approach 
has proved to be the use of a combination of tests to evaluate name 
appropriateness. The concept paper contains FDA's current thinking on 
the logistics and name testing and evaluation under the pilot program. 
However, docket number FDA-2008-N-0281 remains open for comment during 
the pendency of the pilot program and FDA invites comments on human 
factors testing. In addition, after accruing 2 years of experience with 
pilot program submissions, including reviewing applicants' name 
analyses that use alternative methodologies, FDA is committed to 
publish draft guidance on best test practices for proprietary name 
review following public consultation with industry, academia, and 
others from the general public. Thus, the pilot program, in which 
participants are free to propose and provide results of alternate 
methodologies for name assessment, is in part intended to help inform 
potential future program modifications and changes in information 
collected to help prevent medication error.
    3. Concerning the comment that some of the databases listed in the 
concept paper have limited value because of redundancy with the 
collective content

[[Page 28710]]

of the remaining databases, and because they are not amenable to 
automated searching or have more limited automated searching 
capabilities than others, FDA understands that there may be some 
overlap across some of the databases and/or some limitation to 
automated search capabilities. However, as discussed in section IV.A.3. 
of the concept paper, the majority of names with similarity to the 
proposed proprietary name can be identified through database searches, 
and a variety of publicly available databases and resources containing 
product names can be used to identify similar names. FDA itself uses 
databases, the Internet, and other printed and electronic drug product 
resources to search for orthographic and phonological name 
similarities. The concept paper recommends that applicants search a 
variety of sources and, at a minimum, search the publicly available 
databases listed in Appendix A of the concept paper ``Computerized 
Resources'' because these databases are ones that FDA itself uses and 
considers the information in these references useful screening tools if 
properly searched. If a name appears in more than one database, it is 
acceptable to list the name once and list the sources along with the 
identified name. In addition, in most cases, the computerized resources 
listed in Appendix A are publicly available, including the Phonetic 
Orthographic Computer Analysis (POCA) software (see FDA's notice of 
availability in the Federal Register of February 17, 2009 (74 FR 7450). 
As part of the pilot program, FDA encourages sponsors to identify any 
new databases or those databases which are more amenable to automated 
searching.
    FDA estimates the burden of this collection of information in table 
1 of this document. The ``Hours Per Response'' is for all of the 
submissions and notifications to FDA described previously under 
paragraphs 1 to 4 in this document, and is based on information 
provided by industry as well as FDA's familiarity with the time 
required for this information collection as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Number of       Number of Responses       Total Annual
                                                Respondents         per Respondent          Responses       Hours Per  Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Project Proprietary Name Review                       20                      1                   20                  480                    9,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14212 Filed 6-16-09; 8:45 am]
BILLING CODE 4160-01-S


