Manual of Standard Operating Procedures and Policies

General Information - Review

Review of CBER Regulated Product Proprietary Names

SOPP 8001.4

Version #2

Date: November 24, 2008
  1. Purpose
    2.

    This document describes the policies, procedures, and performance goals used in the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) for the review and evaluation of proposed proprietary names for biological products. These procedures are intended to ensure that the requirements set forth for proprietary name reviews under the Prescription Drug User Fee Act (PDUFA IV) in the Food and Drug Administration Amendments Act of 2007 (FDAAA) are met.

    For products not covered by PDUFA, the procedures set forth in this document will be used; however, the performance goals will not apply. CBER will make every effort to respond to proprietary name reviews of non-PDUFA products as expeditiously as possible.

  2. Definitions
    3.

    Medication error - Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. See the web page for the National Coordinating Council for Medication Error Reporting and Prevention located in the reference section of this SOPP.

    Performance goal - Calendar day measurement of the time from the receipt date (stamp date) to the time that the applicant is notified by phone, fax, or letter on the acceptability of the proposed proprietary name. The current performance goals are 180 days for submissions received under an Investigational New Drug (IND) and 90 days for submissions received under a Biologics License Application (BLA) or New Drug Application (NDA). For the purpose of this Standard Operating Procedure and Policy (SOPP), BLA/NDA includes supplements. The performance goal clock is stopped if, upon preliminary review, the submission is incomplete. A new performance goal clock is started when the submission is deemed complete. The contents of a complete submission are provided in Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names.

    Proprietary name - The name that will be used by the applicant or other entity for the commercial distribution of the product. This is the name that will identify the applicant’s specific product in the marketplace following approval by FDA/CBER.

    Review Memorandum – For the purposes of this SOPP, a memorandum generated by the Advertising and Promotional Labeling Branch (APLB) to the product review office summarizing the review and evaluation, with a recommendation, on the acceptability of a proposed proprietary name.

    Tentative acceptance: For the purposes of this SOPP, a recommendation made prior to product approval is considered tentatively accepted when the review is conducted greater than 90 days prior to approval. Proposed proprietary names that are tentatively accepted should be re-evaluated within 90 days of approval to ensure that no new products have entered the marketplace that could give rise to confusion because of similarity in spelling or pronunciation.

  3. Background
    4.

    FDA authority to regulate proprietary names is based on the statute and regulations. The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section 321(n), states that a drug may be misbranded if “the representations made or suggested by statement, word, design, device, or any combination thereof” are misleading. FDA Code of Federal Regulations (CFR) at 21 CFR 201.10(c) states “The labeling of a drug may be misleading by reason … of … (3) The employment of a fanciful proprietary name for a drug or ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name.” … and … (5) Designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient."

    The July 20, 2006 Institute of Medicine (IOM) report “Preventing Medication Errors” cites confusion over the similarity of drug names for prescription, generic, and over-the –counter (OTC) products accounts for up to 25 percent of all errors reported to the U.S. Pharmacopeia. Labeling and packaging issues are cited as the cause of 33 percent of errors, including 30 percent of fatalities. The IOM recommends “Product naming, labeling, and packaging should be designed for the end user – the provider in the clinical environment and/or the consumer” and “Safety should always take precedence over commercial interests.”

    Additionally, in November 2002, the Secretary of Health and Human Services published a report titled Bringing common sense to health care regulation: report of the Secretary’s Advisory Committee on Regulatory Reform - November 21, 2002. This report recommended that FDA adopt safe labeling practices for all FDA-regulated products to improve patient safety and decrease avoidable adverse drug events.

    The prescription drug user fee program of 2007 (PDUFA IV) provides funding for the expedited review of proposed proprietary names to reduce medication errors related to look-alike and sound-alike proprietary names and factors such as unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design. The review of proposed proprietary names will be evaluated under specific performance goals as outlined under Section A: PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 Through 2012.

  4. Policy

    • The primary evaluation of proposed proprietary names is made by the Advertising and Promotional Labeling Branch (APLB) in the Division of Case Management (DCM) in the Office of Compliance and Biologics Quality (OCBQ). APLB is responsible for the review and evaluation of proposed proprietary names and provides recommendations about the acceptability of the proposed names to the product review office. The sponsor should propose at most 2 proprietary names at a time and should specify the primary name of choice. The alternate name will be evaluated only in the event the primary name is found unacceptable.
    • The product review office makes the final decision on the acceptability of the proposed proprietary name. If the product review office and APLB disagree about the acceptability of the proposed proprietary name then a timely joint meeting will be held to discuss their differences.
    • The performance goal for completing the review of proposed proprietary names submitted to an IND is 180 days from receipt at CBER’s Document Control Center (DCC) to the date of communication issuance and, for submissions to a BLA or NDA, it is 90 days. The performance review clock will not begin until a complete proprietary name submission that includes all required elements is received. The elements of a complete submission are provided in Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names.
    • If the proprietary name is found unacceptable, the applicant can request reconsideration by submitting a written rebuttal with supporting data or request a meeting within 60 days to discuss the initial decision. A meeting package is required as provided in Guidance for Industry, Formal Meetings With Sponsors and Applicants for PDUFA Products.
    • If the proprietary name is found unacceptable, the PDUFA IV review performance goals apply to written requests for reconsideration with supporting data or the submission of a new proprietary name. The performance goal for a reconsideration request submitted to an IND is 180 days; it is 90 days for a BLA or NDA.
    • A proprietary name review will be conducted during the NDA/BLA phase under the PDUFA IV review performance goals if the proprietary name was submitted previously (e.g., to the IND) and received tentative acceptance.
    • If a proposed proprietary name was tentatively accepted during the IND phase or beyond 90 days of approval during the BLA or NDA review cycle, APLB will re-evaluate the proposed name within 90 days of the product’s approval goal date to ensure that no new products have entered the marketplace that could give rise to confusion because of similarity in spelling or pronunciation.
    • The final decision on the acceptance of the proposed proprietary name occurs at the time of product approval.
    • Acceptance of a proposed proprietary name for one product does not mean that the name would be acceptable for another product. The proposed proprietary name must be resubmitted for evaluation. For example, a name may be acceptable for one product, but not another product because of different product characteristics such as route of administration, dosage form, and storage conditions.
    • A change to an existing proprietary name should be submitted as a prior approval supplement as described in 21 CFR 601.12(f)(1).
    • A change in ownership/license holder of an application with a subsequent change to the proprietary name requires the new owner/license holder to inform the FDA about the change in the product’s label to include a new proprietary name and should be submitted as a prior approval supplement as described in 21 CFR 601.12(f)(1) and 21 CFR 601.9.
  5. Responsibilities and Procedures
    6.

    Document Control Center (DCC)

    • DCC receives the proprietary name review (PNR) submission under an IND or BLA/NDA. The submission is date-stamped upon receipt and identified as a PNR. This receipt date starts the performance goal clock.
    • For paper PNR submissions, DCC will process and perform the initial routing to the product review office within 3 business days of the receipt date. For electronic submissions, DCC will process, load into CBER’s Electronic Document Room (EDR) and send the load notification to the product review office within 3 business days of the receipt date.

    The Product Review Office

    • Proposed Proprietary Name Reviews Submitted under an IND
    1. Processing and Routing - The product review office is responsible for the processing and routing of the submission.
      • The product review office receives the submission from DCC and promptly processes the submission. Submission refers to any materials submitted by the applicant regarding the proprietary name review, including responses to deficiency communications and proprietary name withdrawals.
      • Processing includes entering into the appropriate regulatory database whether the PNR request is Unknown, Complete, or Incomplete. This determination must be entered within 30 days of receipt.
        • The PNR request is entered as Unknown until APLB notifies the product office that the submission is Complete or Incomplete.
        • Entering a PNR request as Incomplete will stop the performance goal clock.
        • Entering a PNR request as Complete will start the performance goal clock on the receipt date.
    2. Discipline Review Notification - The product review office is responsible for promptly notifying the APLB Branch Chief of the PNR submission.
      The notification should include:
      • IND number, PDUFA goal dates, product review office goal dates
      • a copy of the PNR submission or a link to an electronic submission
      • all other relevant materials/information
    3. Product Review Office Concerns
      • APLB will consult the Medical Officer to determine if he/she has any significant concerns with the acceptability of the proposed proprietary name. The Medical Officer will promptly respond to APLB’s inquiry. The response will be documented in the administrative file of the appropriate submission.
      • If the product review office disagrees with APLB’s recommendations, the product review office will initiate a meeting with APLB staff to discuss the concerns. Additionally, the product review office will document in a memo to the file the reason(s) for not accepting APLB recommendations and will file the memo in the administrative file of the appropriate submission.
    4. Communication with sponsor
      1. The product review office is responsible for the coordination of all communication with the sponsor, including the communication of an incomplete submission and scheduling any external meetings, as necessary.
      2. If a submission is incomplete, the product review office will be notified of the deficiencies by APLB. The product review office will
        • promptly communicate the deficiencies to the sponsor using the letter-ready language that is provided by APLB and enter the communication into the appropriate regulatory database
        • send notification to APLB of the communication
        • reclassify the PNR request as Incomplete in the appropriate regulatory database
        • promptly forward to APLB all additional materials submitted by the sponsor in response to the deficiency communication
        • reclassify the submission from “Unknown” to “Complete” when the APLB reviewer notifies the product review office that the additional materials complete the PNR request submission. The performance goal clock begins on the receipt date of the submission of the additional materials that make the PNR request complete.
      1. If the sponsor withdraws the PNR request submission, the product review office will
        • acknowledge the withdrawal of the PNR request submission with a communication to the sponsor
        • reclassify the submission as “Withdrawn” in the appropriate regulatory database
        • notify APLB that the submission was withdrawn
      2. If the proposed proprietary name is acceptable, the product review office will communicate CBER’s decision on the tentative acceptability of the proposed proprietary name to the sponsor within the PDUFA specified timeframe. If the proposed proprietary name is rejected, the communication to the sponsor will include an explanation as to why the name was rejected. The product review office will notify APLB once the communication is issued. The product review office enters the date of the communication issuance into the appropriate regulatory database to stop the performance clock.
        • If a sponsor appeals the Agency’s decision that a proposed proprietary name is unacceptable and submits supporting data and/or arguments, the product review office will promptly forward the material to the APLB Branch Chief for evaluation. The PDUFA IV performance goals apply to this review process.
        • If a proposed proprietary name(s) is unacceptable and the sponsor submits alternative names (up to 2 names at a time will be accepted), the product review office will follow the same process as for an original PNR request submission. The PDUFA IV performance goals apply to this review process.
    5. Meeting Performance Goals - The product review office, in conjunction with APLB, is responsible for ensuring that the performance goal of 180 days from the DCC receipt date of a complete PNR submission to the date of communication issuance is met.
    6. Pre-BLA/NDA - The product review office will notify the APLB Branch Chief of upcoming End of Phase 2 or pre-BLA/NDA meetings and include the assigned APLB reviewer to the review team. The product review office and/or APLB will request that the sponsor submit a separate amendment to the anticipated marketing application for requesting review of a proposed proprietary name. This can be done at a meeting, (e.g., End of Phase 2 or pre-BLA/NDA, or informally by phone, fax, or e-mail).
  • Proposed Proprietary Name Reviews Submitted under BLA/NDA
    1. Processing and Routing - The product review office is responsible for promptly processing and routing the submission after receipt from DCC. The product review office will
      • log the request for proprietary name review into the appropriate regulatory database as a pending amendment to an original BLA/NDA or as a supplement to an existing (approved) BLA/NDA. If the request is submitted with the original BLA/NDA or a supplement, Proprietary Name Review is added to the Main Category tab.
      • ensure that the APLB Branch Chief assigned a reviewer
      • promptly route the submission to the Medical Officer, APLB, and others, as appropriate
      • contact the applicant on the status and anticipated submission date if the proprietary name review submission is not received within 14 days of the BLA/NDA submission
      • promptly route to APLB all additional materials submitted by the applicant regarding the proprietary name review, such as, responses to deficiency communications and proprietary name withdrawals.
    2. Discipline Review Notification - The product review office is responsible for promptly notifying the APLB Branch Chief of the PNR submission. The notification should include:
      • BLA/NDA number, Product Name, BLA/NDA PDUFA goal dates, product review office goal dates
      • A copy of the PNR submission or a link to an electronic submission
      • All other relevant materials/information
    3. Product Review Office Concerns
      • APLB will consult the Medical Officer to determine if he/she has any significant concerns with the acceptability of the proposed proprietary name. The Medical Officer will promptly respond to APLB’s inquiry. The response will be documented in the administrative file of the appropriate submission.
      • If the product review office disagrees with APLB’s recommendations, the product review office will initiate a meeting with APLB staff to discuss the concerns. Additionally, the product review office will document in a memo to the file the reason(s) for not accepting APLB recommendations and will file the memo in the appropriate application.
    4. Communication with applicant
      1. The product review office is responsible for scheduling any external meetings, as necessary.
      2. If the name is acceptable, the product review office will communicate CBER’s decision on the acceptability of the proposed proprietary name to the applicant within the PDUFA specified timeframe. If the name is rejected, the communication to the applicant will include a detailed explanation as to why the name was rejected. The product review office will enter the communication date into the appropriate regulatory database and notify APLB of the communication. The date of communication issuance stops the performance clock.
      3. If a proposed proprietary name(s) is unacceptable and the applicant submits an amendment with alternative names (up to 2 names will be accepted), the product review office will promptly forward the submission to the review team for evaluation. The PDUFA IV performance goals apply to this review process.
    5. Meeting Performance Goals - The product review office, in conjunction with APLB, is responsible for ensuring that the performance goal of 90 days from the DCC receipt date of a complete submission to the date of communication issuance is met.

    Advertising and Promotional Labeling Branch

    • Proposed Proprietary Name Reviews Submitted under an IND
      1. Receipt and Processing
        1. The Branch Chief will assign the PNR submission to an APLB reviewer and inform the product review office of the assignment.
        2. The APLB reviewer will promptly review the submission for completeness as provided in the Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names
        3. If the submission is incomplete, the APLB reviewer will prepare a deficiency Review Memo with letter-ready language
          • upload the deficiency Review Memo into the EDR and send a notification to the product review office
          • notify the product review office to reclassify the submission as complete when the applicant submits all of the documents, in response to the deficiency communication, that make the submission complete
        4. If the submission is deemed complete, the APLB reviewer will notify the product review office to reclassify the submission from “unknown” to “complete.”
      2. Review Process - The APLB reviewer will
        1. review and evaluate the proposed name(s)
        2. ask the Medical Officer if there are any significant concerns with the acceptability of the proposed proprietary name within 30 days of the APLB receipt date.
          • the Medical Officer’s response will be incorporated into APLB’s recommendation Review Memo
        3. consult with the Office of Biostatistics and Epidemiology to address any safety concerns
        4. prepare a recommendation Review Memo with letter-ready language regarding the acceptability of the proposed proprietary name and the requirement of a re-evaluation of the proposed proprietary name when the BLA/NDA is submitted
          • upload the recommendation Review Memo, with the Medical Officer’s response incorporated, into the EDR and send a notification to the review team
          • submit the Review Memo to the product review office in a reasonable time frame to provide ample time for the product review office to schedule internal meetings, if necessary, before the performance goal date
      3. Pre-BLA/NDA – Both the product review office and APLB reviewer will ensure that a request is made to the applicant to submit a separate amendment requesting a review of their proposed proprietary name within 14 days of submitting the original or supplemental marketing application. The request can be made at a milestone meeting, e.g., End of Phase 2 or pre-BLA/NDA, or informally by phone, fax, or e-mail.
  • Proposed Proprietary Name Reviews Submitted under BLA/NDA

    Note: If the proprietary name was previously submitted and received tentative acceptance, then a re-evaluation will be completed within 90 days of the product’s approval goal date (see 3. Re-evaluation of a tentatively acceptable proposed proprietary name below).

  1. Receipt and Processing
    1. The Branch Chief will assign the PNR submission to an APLB reviewer and inform the RPM of the assignment.
    2. The APLB reviewer will promptly review the submission for completeness. See Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, for required elements.
    3. If the submission is incomplete, the APLB reviewer will
      • prepare a deficiency Review Memo
      • issue the deficiency Review Memo to the applicant
      • enter the communication into the appropriate regulatory database to stop the performance goal clock
      • upload the deficiency Review Memo into the EDR and send notification to the review team
      • start a new performance clock when all of the documents are received from the applicant to deem the submission complete, in response to the deficiency communication, and notify the product review office
    4. If the submission is complete, the APLB reviewer will notify the product review office that the performance goal clock can continue.
    5. If the request for proprietary name review is withdrawn by the applicant, APLB will acknowledge the withdrawal of the PNR request submission with a communication to the applicant and enter PNR Withdrawn into the appropriate regulatory database to stop the performance goal clock.
  2. Review Process – The APLB reviewer will
    1. review and evaluate the proposed name(s)
    2. ask the Medical Officer if he/she has any significant concerns with the acceptability of the proposed proprietary name within 30 days of APLB receipt of the assignment
      • the Medical Officer’s response will be incorporated into APLB’s recommendation Review Memo
    3. consult with the Office of Biostatistics and Epidemiology to address any safety concerns
    4. prepare a recommendation Review Memo with letter-ready language regarding the acceptability of the proposed proprietary name and the requirement of a re-evaluation of the proposed proprietary name if the previous review was greater than 90 days before application approval
      • enter the Review Memo into the appropriate regulatory database
      • upload the recommendation Review Memo, with the Medical Officer’s response incorporated, into the EDR and send a notification to the review team
      • submit the recommendation Review Memo to the product review office within 60 calendar days of receipt in APLB or before the performance goal date
  3. Re-evaluation of a tentatively acceptable proposed proprietary name
    1. If the proprietary name has received tentative acceptance, and the last review was conducted greater than 90 days before application approval, APLB will re-evaluate the proposed proprietary name when the product is within 90 days of approval.
      • Proposed proprietary names reviewed under an IND will require a re-evaluation by APLB when the application is submitted under the BLA/NDA.
      • This 90-day re-evaluation is considered the final evaluation. The review is to be limited to a check for conflict with currently approved product names and performed prior to approval, if feasible.
      • The performance goals do not apply to the re-evaluation.
    2. The APLB reviewer will
      • re-evaluate the proprietary name within 90 calendar days before application approval if the review was conducted more than 90 calendar days before application approval
      • prepare a recommendation Review Memo on the continued acceptability of the proposed name or if the proposed name is no longer acceptable, include letter-ready language with reasons for why the proposed proprietary name is no longer considered acceptable
      • upload the recommendation Review Memo into the EDR and send a notification to the review team
      • a separate communication to the applicant is not required if the recommendation is continued acceptability of the proposed name
    Request for Reconsideration of a Recommendation
  • If the proprietary name is found unacceptable, the applicant may request reconsideration by submitting a written rebuttal with supporting data or request a meeting within 60 days to discuss the initial decision. A meeting package is required as provided in Guidance for Industry, Formal Meetings With Sponsors and Applicants for PDUFA Products.
  • The APLB reviewer will review the new information and forward the final recommendation with letter-ready language to the product review office. The PDUFA IV review performance goals apply to written requests for reconsideration with supporting data or the submission of a new proprietary name.
  1. References

Prescription Drug User Fee Act ; Section A: PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012.

Food and Drug Administration Amendments Act of 2007

Institute of Medicine (IOM) report “Preventing Medication Errors”, July 20, 2006

National Coordinating Council for Medication Error Reporting and Prevention

Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names

Guidance for Industry, Formal Meetings With Sponsors and Applicants for PDUFA Products

November 2002, the Secretary of Health and Human Services report: Bringing common sense to health care regulation: report of the Secretary’s Advisory Committee on Regulatory Reform - November 21, 2002.

  1. Effective Date
    2.

    November 24, 2008

  2. History

    3. Written/Revised Approved Approval Date Version Number Comment
    Catherine Miller Robert Yetter, PhD Sept 30, 2008 2 Revisions to content pursuant to FDAAA and PDUFA IV
    Mary Malarkey Robert Yetter, Ph.D. August 15, 2002 1 Original Document

 
Updated: November 26, 2008