[Federal Register Volume 73, Number 92 (Monday, May 12, 2008)]
[Notices]
[Pages 27001-27002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0281]


Pilot Program to Evaluate Proposed Name Submissions; Concept 
Paper; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting; request for comments.

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SUMMARY:  The Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) of the Food and 
Drug Administration (FDA) are announcing a public technical meeting in 
preparation for a pilot program to enable pharmaceutical firms to 
evaluate proposed propriety names and submit the data generated from 
those evaluations to FDA for review. The purpose of the public 
technical meeting is to discuss a concept paper that describes the 
logistics of the pilot program, proposed recommendations for carrying 
out a proprietary name review, and the way FDA intends to review 
submissions made under the pilot program. FDA plans to formally issue 
the concept paper by the end of fiscal year (FY) 2008 and expects to 
begin enrollment in the pilot program in FY 2009.

DATES:  The public meeting will be held on June 5 and 6, 2008, from 
8:30 a.m. to 5 p.m. each day. Register to make a presentation at the 
meeting by May 23, 2008. See section III of this document for 
information on how to attend or present at the meeting. Submit any 
written or electronic comments regarding the concept paper and pilot 
program by July 7, 2008.

ADDRESSES:  The public meeting will be held at the Crowne Plaza Hotel, 
877 Georgia Ave., Silver Spring, MD 20910 (Metro: Silver Spring Station 
on the Red Line). Submit written or electronic requests to make a 
presentation at the meeting to Lana Pauls (see FOR FURTHER INFORMATION 
CONTACT). A draft concept paper will be available soon.
    Comment Submissions: Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Lana Pauls, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301-796-
0518, FAX: 301-847-8753, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Institute of Medicine (IOM) in its 2006 report ``Preventing 
Medication Errors'' noted that ``[i]n particular, drug names that look 
or sound alike increase the risk of medication errors.'' FDA also has 
determined that many of the medication errors reported to the agency 
result from proprietary names that look or sound like the names of 
other medical products. Reducing the potential for medication errors 
due to proprietary name confusion is part of FDA's ongoing medical 
product risk management effort. In 2003, FDA held two public meetings 
that explored many of the issues involved in proprietary name review:
     The June 26, 2003, public meeting on ``Minimizing 
Medication Errors--Methods for Evaluating Proprietary Names for Their 
Confusion Potential,'' Docket No. 2002N-0201 (68 FR 32529, May 30, 
2003). Information about the meeting is available at http://www.fda.gov/cder/meeting/drugNaming.htm.
     The December 4, 2003, meeting of the Drug Safety and Risk 
Management Advisory Committee (68 FR 65075, November 18, 2003). 
Transcripts, presentations, and materials from the meeting are 
available at http://www.fda.gov/ohrms/dockets/ac/cder03.html#DrugSafetyRiskManagement.
    FDA reviews proprietary names from both promotional and safety 
perspectives. The promotional review of proposed names considers 
whether the name functions to overstate the efficacy, minimize the 
risk, broaden the indication, make unsubstantiated superiority claims 
for the product, or is overly fanciful. The safety review of a proposed 
name is based on the findings of a Failure Modes and Effects Analysis 
of the proprietary name, and is focused on the avoidance of medical 
errors. FDA not only considers the potential for a name to be spelled 
similarly and/or sound similar to 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 
reasons other than look and sound-alike name confusion, for instance 
whether the abbreviation for the drug would be similar to the 
abbreviation of another drug product.
    Consideration also is given to the proposed product's 
characteristics including its intended use, dosage form and 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. In addition, because product-name confusion can occur at any 
point in the medication use process, FDA considers the potential for 
confusion throughout the process, including product procurement, 
prescribing and ordering, dispensing, administration, and monitoring 
the impact of the medication.
    Currently, the data generated to access this information is 
internal to FDA. However, there have been a number of calls for 
industry to become involved in the name testing process including

[[Page 27002]]

IOM's 2006 report, IOM's 1999 report ``To Err is Human,'' 
Recommendation 238 from the HHS Advisory Committee on 
Regulatory Reform's November 21, 2002 report, and, most recently, in 
the Prescription Drug User Fee Act (PDUFA IV) performance goals.
    In Title I of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Public Law 110-85), Congress reauthorized and expanded 
the Prescription Drug User Fee program for FY 2008 through FY 2012 
(PDUFA IV). As part of the performance goals and procedures set forth 
in an enclosure to the letter from the Secretary of the Health and 
Human Services referred to in section 101(c) of FDAAA, FDA agreed to 
publish a concept paper on and implement a pilot program to enable 
pharmaceutical firms participating in the pilot to evaluate proposed 
proprietary names and submit the data generated from those evaluations 
to FDA for review. This process is consistent with other areas of drug 
review in which FDA evaluates data generated by firms rather than 
producing such data independently. FDA intends the concept paper to 
provide transparency to the FDA review processes, as well as to provide 
a consistent, scientific approach to the review of proprietary names 
data. FDA agreed to conduct a public meeting to discuss the content of 
the concept paper, which will describe the logistics of the pilot 
program, proposed recommendations for carrying out a proprietary name 
review, and the way FDA intends to review submissions made under the 
pilot program. FDA is developing the concept paper, which contains its 
current thinking on the logistics of the pilot and name testing and 
evaluation under the pilot. The concept paper will be available at the 
Division of Dockets Management and on the Internet prior to the meeting 
(see ADDRESSES). FDA welcomes written and electronic comments on the 
draft concept paper before and after the public meeting (see section IV 
of this document).

II. Scope of Public Meeting

    At the public meeting, FDA will present its current thinking on 
proprietary name review testing and the proposed pilot program, and 
will solicit feedback from industry, patient safety groups, academics, 
health care professionals, other governmental agencies, and the public. 
The meeting will include panel discussions and individual and/or joint 
presentations. Some of the key questions that will be considered at the 
meeting include, but are not limited to, the following:
    1. What are best practices in safety and promotional testing of 
proprietary names? What are the limitations of current methods and how 
may they be overcome?
    2. What combination of tests should be undertaken and what data 
should be submitted by sponsors participating in the pilot? Discussion 
of testing procedures should focus on advances in the field of name 
testing since the 2003 public meetings (e.g., improvements in test 
design, accuracy, and validation, as well as use of practitioner input 
in the range of clinical settings in which drugs are procured, 
prescribed, prepared/dispensed, administered, and monitored).
    3. How should testing be standardized to achieve valid, reliable 
results across studies?
    4. What criteria should FDA consider in evaluating the testing done 
and the data submitted?
    5. How should the pilot program be structured and evaluated?
    6. Are there any public health concerns raised by the pilot program 
and how should they be addressed?
    Speakers who wish to present material in the public meeting must 
register before the meeting (see section III of this document). Time 
will be allowed for questions and answers after each panel discussion.
    Information gathered from the meeting and from comments submitted 
to the docket will be used to develop the final concept paper. FDA 
intends to publish the final concept paper by the end of FY 2008 and 
expects to begin enrollment in the pilot in FY 2009.

III. Attendance and Registration

    There is no fee to attend the meeting, and attendees who do not 
wish to make an oral presentation do not need to register. Seating will 
be on a first-come, first-served basis.
    If you would like to make an oral presentation during the meeting, 
you must register and provide an abstract of your presentation by close 
of business on May 23, 2008. You must provide your name, title, 
business affiliation (if applicable), address, telephone and fax 
numbers, and e-mail address to Lana Pauls (see FOR FURTHER INFORMATION 
CONTACT). You should identify the topic or section of the draft concept 
paper you wish to address in your presentation, whether you wish to 
address comments on day one or day two, and the approximate time 
requested for your presentation. FDA has identified topics of special 
interest in section II of this document and is posting a draft concept 
paper and agenda on the Internet (see ADDRESSES). The Centers may 
change the time allotted depending on the number of people requesting 
to present. Individuals and organizations with common interests are 
urged to consolidate or coordinate their presentations and to request 
time for a joint presentation. Persons registered to make an oral 
presentation should check in before the meeting. If you need special 
accommodations because of disability, please contact Lana Pauls (see 
FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding issues and 
questions presented in the concept paper or at the meeting. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. 
It may be viewed at the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: May 6, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10513 Filed 5-9-08; 8:45 am]
BILLING CODE 4160-01-S