[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Notices]
[Pages 43751-43753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1008]


Exploring the Possibility of Proprietary Name Reservation for 
Drug Products; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to discuss issues related to reserving 
proprietary names for drug products. During the negotiations for the 
2007 reauthorization of the Prescription Drug User Fee Amendments Act 
(PDUFA IV), FDA agreed to several performance goals related to the 
review of drug and biological product proprietary names to reduce 
medication error. Among those goals, FDA and industry expressed an

[[Page 43752]]

interest in exploring the possibility of ``reserving'' proprietary 
names for companies once the names have been tentatively accepted by 
the Agency. Accordingly, FDA is initiating a public process to discuss 
issues around reserving proprietary names.

DATES: Submit electronic or written comments by October 27, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kellie Taylor, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301-
796-0157, [email protected]; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

A. Proprietary Name Review Activities Under PDUFA IV

    In conjunction with the 2007 reauthorization of PDUFA IV, FDA 
agreed to a number of performance goals related to the Agency's review 
of drug and biological product proprietary names to reduce medication 
error. For the first time, the Agency agreed to a process and timelines 
for notifying applicants of the tentative acceptance or nonacceptance 
of a proposed proprietary name. These proprietary name review 
performance goals and timelines are separate from the timelines for 
approval of underlying new drug applications and biologics license 
applications. These goals and timelines also permit sponsors or 
applicants to obtain such a notification as early as during the 
investigational new drug stage, any time after the completion of a 
Phase II study.
    Pursuant to related PDUFA IV goals, the Agency also undertook 
several other measures intended to provide additional transparency 
regarding the methods and tools that FDA uses in considering whether a 
proposed proprietary name is likely to contribute to medication error 
or otherwise render the drug misbranded. (See, for example, Guidance 
for Industry, Contents of a Complete Submission for the Evaluation of 
Proprietary Names, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075068.pdf PDUFA 
Pilot Project, Proprietary Name Review, Concept Paper, available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072229.pdf and 
http://www.gpo.gov/fdsys/pkg/FR-2009-02-17/pdf/E9-3170.pdf.) The 
guidance on Contents of a Complete Submission for the Evaluation of 
Proprietary Names also lays out the legal basis for FDA's review of 
drug proprietary names, derived from its authority over labeling and 
the requirements for product approval.
    In accordance with the performance goals described above, since 
fiscal year (FY) 2008, FDA has provided a mechanism for applicants to 
be notified that the Agency considers a proprietary name to be 
unacceptable before final approval of the underlying product 
application. This process enables applicants to plan more effectively 
for postapproval marketing, for example, by seeking reconsideration of 
a proposed proprietary name that FDA considers problematic or by 
proposing an alternative name. However, because the ultimate approval 
of a proprietary name comes as part of the approval of the drug 
labeling, and thus is not final until the approval of a marketing 
application, the positive outcome of a proprietary name review that is 
completed before application approval is limited to a tentative 
acceptance of that name. It is possible that a name judged tentatively 
acceptable may later be found unacceptable for a number of reasons, 
including, for example, the intervening entry into the U.S. market of 
another product with a confusingly similar name, changes in the 
product's characteristics during review, or new information about the 
likelihood of error arising from postmarketing data about another 
product.
    Stakeholders have indicated that the existing process does not 
provide applicants with sufficient certainty, prior to approval of 
their application, that a proposed proprietary name will be included in 
approved drug labeling. Some members of industry have suggested that 
they remain particularly concerned that a ``tentatively acceptable'' 
name may be subsequently rejected because of the intervening approval 
of another drug whose application was pending, but not public, at the 
same time as their own. In the documentation regarding its pilot 
program for proprietary name review, FDA acknowledged that it may be 
unable to disclose certain information to an applicant in connection 
with a proprietary name review. (See PDUFA Pilot Project, Proprietary 
Name Review, Concept Paper at 31-32, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072229.pdf.) (``[I]n some cases FDA has access to information that 
is not publicly available to applicants.'').
    In such cases, FDA will communicate with the applicant to the 
extent permitted by law to describe the nature of this information. One 
example of this is where other proprietary names are being considered 
by the Agency at the same time, and the Agency believes that the 
proposed names would be likely to cause confusion or medication error. 
Under FDA's regulations, information in an unapproved application, 
including proposed proprietary names, is generally not publicly 
available (see 21 CFR 312.130, 314.430, 601.50, and 601.51). In such 
situations, FDA generally notifies applicants that their proposed 
proprietary name could result in medication errors due to confusion 
with another product that is also under review and informs the 
applicant that acceptability of a proposed proprietary name may be 
affected by prior approval of the other product.

B. Current Action: Establishment of a Public Docket To Discuss Issues 
Around ``Reserving'' Proprietary Names for Drugs

    FDA is now establishing a public docket in furtherance of the 
following additional proprietary name review-related performance goal, 
contained in the PDUFA IV goals letter:
    ``FDA and industry are interested in exploring the possibility of 
``reserving'' proprietary names for companies once the names have been 
tentatively accepted by the Agency. By the end of FY 08, FDA will 
initiate a public process to discuss issues around ``reserving'' 
proprietary names.''
    In January 2009, staff from FDA met with representatives from the 
Pharmaceutical Research and Manufacturers of America (PhRMA) to discuss 
the proposed program. At that time, PhRMA offered to submit a draft 
guidance for comment. PhRMA did submit a draft guidance entitled 
``Early Review of Proprietary Names'' to FDA for consideration. FDA has 
placed PhRMA's proposed guidance document in the newly established 
public docket for information pertaining to a possible name reserve 
program, so that it is available to all interested members of the 
public.

[[Page 43753]]

II. Comments

    Interested persons may submit either written comments to the 
Division of Dockets Management (see ADDRESSES) or electronic comments 
to http://www.regulations.gov. It is only necessary to send one set of 
comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
    FDA invites comment on all matters relating to a potential program 
for reserving proprietary names for drug products. This request is not 
limited to comments on the proposal described in the submission by 
PhRMA. FDA is particularly interested in comments and information 
regarding the following:
     Are there examples of drug market launches being delayed, 
or of drugs being launched without a proprietary name, because FDA's 
determination that a proposed proprietary name would not be acceptable 
came too close to the date of product approval? If so, please provide 
details, including how far in advance of approval the applicant 
submitted the proposed name to the Agency, whether the proposed name 
had been tentatively accepted, and how long the launch was delayed or 
how long the product was marketed without a proprietary name.
     Potential approaches for reserving proprietary names that 
would create more certainty for applicants than the current ``tentative 
acceptance'' process. For each proposed approach, please describe the 
following:
    [cir] How the program would create certainty while balancing the 
need to avoid or minimize the risk of medication error.
    [cir] The parameters of the proposed program, including whether 
participation in the program should be voluntary or mandatory; what 
conditions should be met before a name is ``reserved''; and for how 
long a name may be ``reserved.''
    [cir] The procedural and legal framework for the proposed program.
    [cir] Whether the ``reservation'' of a proprietary name for one 
applicant would be binding, such that a similar or identical 
proprietary name for another applicant's drug would be rejected, even 
in situations in which such drug is ready for approval before that of 
the applicant for whom the name is ``reserved.''
    [cir] A discussion of the application of the program to over-the-
counter monograph products and drugs that are manufactured for a 
private label distributor, under an existing approved application.
     Data and information regarding:
    [cir] The number of applicants that would be interested in 
participating in a voluntary name reservation program.
    [cir] Whether applicants would be willing to participate 
voluntarily if ``reservation'' of a name is not guaranteed to prevent 
the use of the name by all other drugs that enter the U.S. market prior 
to the drug for which the name is ``reserved.''
     In the absence of a binding name reservation program, what 
measures could be used to provide greater predictability to applicants 
about the likelihood that a name found tentatively acceptable will 
subsequently be approved? Can industry address this without FDA 
involvement, for example, through a voluntary posting of proposed 
names?
     Under current FDA regulations, information in an 
unapproved application, including proposed proprietary names, is 
generally not publicly available (see 21 CFR 312.130, 314.430, 601.50 & 
601.51). What mechanisms could be used to provide notice to an 
applicant of possible confusion between its proposed proprietary name 
and other proposed proprietary names contained in pending applications?

    Dated: July 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17691 Filed 7-25-14; 8:45 am]
BILLING CODE 4164-01-P