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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8506: Management of Shortages of CBER-Regulated Products

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Version #2 

Effective Date: April 9, 2012 


 

  1. Purpose

    This Standard Operating Policy and Procedure (SOPP) establishes for the Center for Biologics Evaluation and Research (CBER) staff the procedures and policies for the receipt, evaluation and follow up to actual or potential product shortages and additional steps to be taken in the event of actual shortages of medically necessary products that can have significant public health consequences
     
  2. Scope
     
    This SOPP applies to all products regulated by CBER.

  3. Background
     
    1. Actual or potential shortages may be reported to CBER by a variety of persons, including:
      1. Medical professionals
      2. Consumers/patients
      3. Manufacturers
      4. Other government offices
      5. Patient advocacy groups
      6. Media sources, and others
         
    2. Reports may come to CBER through:
      1. The CBER Shortage email account at CBERshortage@fda.hhs.gov
      2. The CBER Biological Product Shortages dedicated phone line at (301) 827-4239
      3. CBER’s Office of Communication, Outreach and Development (OCOD)
      4. Media reports or inquiries from the FDA's Press Office
      5. Industry through CBER’s Product Offices
      6. Patients/consumers individually or through associations
      7. Agency surveillance and enforcement
      8. Healthcare provider reports filed in the:
        1. Drug Quality Reporting System
        2. Med Watch
        3. Vaccine Adverse Event Reporting System (VAERS)
      9. CBER Biological Product Deviation Reporting System
         
    3. Product shortages can arise for a variety of reasons and can be broadly classified as compliance-related or related to other events.
       
    4. Product shortages related to other events can occur as a result of distribution or production changes, unavailability of component materials, changes in release procedures, expanded use indications, modifications in promotional campaigns, increased demand, business decisions, and catastrophic events.
       
    5. Compliance-related product shortages can occur as a result of implementation of corrective measures to assure that a product is safe, pure, potent, and labeled in conformance with the firm's approved application.
       
    6. Typically a product shortage exists when the total supply of all versions of the approved product available at the market level from either the same manufacturer or an approved alternative manufacturer will not meet the current or projected market demand for the medically necessary use(s).
       
  4. Definitions
     
    1. Product Shortage - A product shortage occurs when a product is not commercially available in sufficient quantity to meet the demand.
       
    2. Medically Necessary Product - A product is considered medically necessary when it is used to treat, cure, mitigate, prevent, or diagnose a serious disease or medical condition and there is no adequate alternative product available for that use. Note: Patient inconvenience alone is an insufficient basis to classify a product as a medical necessity.
       
    3. RMS/BLA: Regulatory Management System/Biologics License Applications – the regulatory database used for managing CBER’s biologics licensing processes.
       
  5. Policy
     
    1. It is FDA policy to consider the best interest of the public health when assessing actions related to shortages of medically necessary products.
       
    2. The appropriate CBER Product Office - Office of Blood Research and Review (OBRR), and/or the Office of Cellular, Tissue, and Gene Therapy (OCTGT), and/or the Office of Vaccine Research and Review (OVRR) - will identify and gather all necessary information about products for which there is a report of an actual or potential shortage, and determine if the product is medically necessary.
       
    3. The Office of Compliance and Biologics Quality (OCBQ) processes regulatory action recommendations. One of the many considerations in deciding on the appropriate action to take is the overall effect of the action on the availability of the products that are manufactured by the company that is the subject of the potential action.
       
    4. In matters of enforcement that would potentially result in shortages of medically necessary product(s), OCBQ will consult with CBER Product Offices and the Office of Regulatory Affairs (ORA) Field Offices prior to concurring with any recommended regulatory action(s).
       
    5. Where agency actions may impact the supply of medically necessary products, CBER carefully considers the alternatives. In an event where agency action may impact the supply of medically necessary products, CBER carefully considers whether to exercise enforcement discretion in taking regulatory action.
       
      1. A decision on whether or not to take enforcement action is based on careful consideration of the impact of the violations on the quality of the product, the medical risks associated with the violations, and any other factor(s) that CBER may deem relevant. 
      2. If CBER determines that the shortage of a medically necessary product is not compliance related, (e.g., manufacturing facility destroyed by fire, facility closed for renovations), special actions may be taken by CBER to help alleviate the shortage. Special actions may range from discussions with industry to acceleration of review activities or lot release. 
      3. If CBER determines that the shortage of a medically necessary product is compliance-related (e.g., approved product does not meet any or all of the specification(s) in the license):
        1. CBER may consider whether or not to modify enforcement actions to address the impact on the availability of medically necessary products. (In some circumstances, the agency may exercise enforcement discretion or facilitate an expedited review.)
        2. CBER may decide to modify enforcement actions based on careful consideration of the impact of the violation(s) on the quality of the product, the risks to the public that would result from use of the product versus inability of the public to use the product, and other factors CBER may deem relevant.
        3. CBER may include input from CBER Product Offices, Office of the Chief Counsel (OCC), and Office of CBER Director (OD).
        4. CBER may also consider taking special actions deemed relevant to the individual situation to help alleviate the shortage.
           
  6. Responsibilities
     
    1. CBER Product Shortage Coordinator (PSC) - Office of Compliance and Biologics Quality (OCBQ), Immediate Office of the Director (IOD).

      1. Receives all reports of potential or actual product shortages.
      2. Evaluates each potential or actual product shortage.
      3. Communicates each actual product shortage information to product offices so that the product offices can evaluate the status of each new shortage report and, when necessary, determine medical necessity of the product in shortage.
      4. Ensures that product shortage information posted on the CBER Biologic Product Shortage Web page is accurate and current.
      5. Ensures that updated public information is posted on the CBER Biologic Product Shortage Web page as soon as possible.
      6. Enters and tracks the submission in RMS-BLA.
    2. CBER Product Offices (with product review responsibilities) - OBRR, OCTGT, and OVRR

      1. Designates one or more Office Product Shortage Representative(s) whose responsibility will be to evaluate the status of each new shortage report and, when necessary, determine medical necessity of the product in shortage.
      2. Regulatory Project Management (RPM) Branch Chief within the CBER Product Offices (if there is no Product Shortage Representative):
        1. Serves as the Office representative for the purposes of triaging the report.
        2. Forwards the report to the appropriate review personnel within the Office.
    3. CBER Office of Communication, Outreach and Development (OCOD)

      1. Forwards all reports and inquiries received by OCOD concerning product availability to the PSC.
      2. Posts the information concerning confirmed product shortages on the CBER Biologic Product Shortage Web page.
    4. CBER Office of Biostatistics and Epidemiology (OBE)
      1. Forwards all Med Watch and VAERS reports concerning actual or potential product shortages to the PSC at CBERshortage@fda.hhs.gov
      2. Assists the Product Offices and the PSC as necessary in assessing such reports.
    5. FDA Office of Regulatory Affairs (ORA)

      District Offices will:

      1. Forward all information concerning CBER product shortage situations that do not involve compliance issues directly to the PSC via the product shortage email account at CBERshortage@fda.hhs.gov or via phone call at (301) 827-4239.
      2. Alert the OCBQ’s PSC to all product shortage situations involving compliance issues at CBERshortage@fda.hhs.gov or at (301) 827-4239.
      3. Work with CBER as necessary in determining the nature and scope of all product shortage situations.
         
  7. Procedures

    1. Forward all reports or inquiries, including MedWatch and VAERS reports, concerning actual or potential product shortages to the CBER Product Shortage Coordinator (PSC) in OCBQ. [CBER Product Office(s) (OBRR, OCBQ, OCTGT, OVRR), OBE, OCOD, ORA and/or RPM’s from Product Offices]
       
      1. If there is an emergency that requires immediate attention, the CBER staff member receiving the report will attempt to contact the PSC by phone at (301) 827-4239.
      2. If the situation is not urgent, the person receiving the report/inquiry will promptly send it to CBERshortage@fda.hhs.gov
    2. Forward each report of new shortage to the appropriate CBER Product Office contact person. [PSC]

    3. Assign number in RMS-BLA per SOPP 8416: CBER Initiated Second Level STNs. [PSC]

    4. Forward to appropriate review personnel within Office. [RPM Branch Chief]

    5. Evaluation of the actual or potential product shortage. [CBER Product Office(s)]

      The evaluation will include:
       
      1. Data identifying manufacturers of similar versions of the shortage product as well as data showing total units of product distribution in the United States (U.S.).
      2. Inventory data of product available at the manufacturer(s) and major wholesalers throughout the U.S.
      3. Reports of the 30-day back order status of the manufacturer.
      4. Reports from health care personnel, consumers, trade or patient groups regarding current and projected product availability and demand.
      5. A determination if the product in shortage is medically necessary or not.
        1. Typically, if an alternative product compliant with FDA's current Good Manufacturing Practice regulations (cGMPs) exists, is in adequate supply, and could be used to treat the same serious disease or medical condition as the shortage product then the product may not be considered to be medically necessary.
        2. If there is not an alternative product available then the product may be considered to be medically necessary.
        3. In certain instances when the decision about whether or not the product is medically necessary is particularly complex, the Product Office Representative will consult with CBER management.
      6. A determination if the medically necessary product in shortage is or is not compliance related.
        1. If CBER determines that the shortage of a medically necessary product is not compliance related, (e.g., manufacturing facility destroyed by fire, facility closed for renovations, natural disaster), special actions may be taken by CBER to help alleviate the shortage.
           
    6. Within five (5) working days of receipt of the report by the Product Office enter completed evaluation in RMS-BLA and import into the EDR. Send an email to the CBER PSC at CBERshortage@fda.hhs.gov notifying the PSC that the evaluation is completed and in the EDR. [CBER Product Office POC]

    7. Submit public product shortage information to OCOD for posting on the CBER Biologic Product Shortages Web page and ensure posted information remains current. [CBER PSC]

      The information to be supplied to OCOD for posting should include:

      1. Product brand name;
      2. Product trade name;
      3. Manufacturer name;
      4. Reason for shortage;
      5. Date shortage began;
      6. Manufacturer recommendation(s) or additional information (if provided by the manufacturer) intended for public use (e.g. weblinks, phone numbers, etc);
         
    8. All meetings, telecons, etc will be documented and included in RMS-BLA and imported into the EDR. [CBER PSC, RPM, Product Reviewer]

  8. Appendix
     
    N/A

  9. References
     
    1. Web links to the references below can be found in the list following the History Table
      1. Draft Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (February 2012)
         
  10. History 
     

Comment/Revision
Approved By
Approval Date
Version Number
Comment
J. Manik, A. Richardson, OCBQ Robert Yetter, Ph.D.  March 29, 2012 2Revised to include new procedures 
M. Knippen, J. Davis (OCBQ)Robert Yetter, Ph.D.January 2, 20041Original