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U.S. Department of Health and Human Services

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2004 Annual Report

Background

The Ombudsman position was established in the Center for Veterinary Medicine (CVM) in November of 1999. The CVM Ombudsman 1) handles complaints and helps to resolve disputes involving science and policy issues for products regulated by CVM and 2) is a point of contact for response to inquiries and requests for general information and for information on specific issues involving science, policy and procedures or for referral to the appropriate resource within the Center. Additionally, the Ombudsman advises the Office of the Center Director (OD) concerning any trends in the reoccurrence of specific issues or problems that may have an impact on Center policy and makes recommendations for change or improvement.

The purpose of this report is to provide an overview of the Ombudsman’s activities for the calendar year 2004.

General Categories and Subjects

The issues handled by the CVM Ombudsman during 2004 can be categorized generally as 1) complaints concerning Adverse Drug Experiences (ADEs) for specific important products regulated by CVM, 2) complaints/comments about the implementation and interpretation of updated and new FDA/CVM policies, 3) inquiries and questions about FDA policy regarding specific issues/products, and 4) requests for general information on the review/approval process. These categories covered the following subjects/areas:

  • Adverse Drug Experience (ADE)
  • User Fees and Waivers
  • Animal Research
  • Aquaculture
  • BSE Issues
  • Center Contacts/Direct Referrals
  • Marketing Status
  • Compounding
  • Dietary Supplements
  • Drug Import/Export
  • Extra-label Use
  • Food Additives
  • Freedom of Information (FOI) requests
  • INAD/NADA/ANADA Process
  • Internet Pharmacies
  • Illegal Marketing Unapproved products
  • Manufacturing Issues
  • Media Related Inquiries
  • Minor Species
  • Pet Food/Products
  • Veal Calf Implants
  • Veterinary Biologicals
  • Veterinary Devices
  • Veterinary Practice Ethics
  • Veterinary Medicine Advisory Committee (VMAC)

There were a total of 165 complaints and inquiries handled by the CVM Ombudsman during the 2004 calendar year. The majority (98%) of these originated outside the Center from consumers, scientists and other professionals, private industry and other Offices/Centers within FDA. Only 2% of the inquiries originated from inside CVM. A small number (3%) of the complaints or inquiries were referred to the Ombudsman either from another Center Ombudsman or the Office of the FDA Ombudsman (OO). The Ombudsman was generally contacted directly by e-mail and by telephone.

Science and Policy

As stated above, the Ombudsman handles science and/or policy issues related to products regulated by CVM. The complaints and inquiries received during 2004 for the subjects/areas listed above, involved one or both issues as follows:

  • New Animal Drug det./data requirements
  • Code of Federal Regulations (CFR)
  • Regulatory Discretion
  • ADE Reporting Procedures/Data base
  • Personal Import Policy
  • Animal Medicinal Drug Use and Clarification Act (AMDUCA)
  • Animal Drug User Fee Act (ADUFA)
  • Dietary Supplement Health and Education Act (DSHEA)
  • Export Certificates
  • Food Additive Petition (FAP)/Informal Opinion
  • Medically Necessary Veterinary Product (MNVP)
  • Minor Use Minor Species (MUMS)
  • CVM Product Jurisdiction
  • CVM Guidance for Industry Documents
  • Ombudsman Function/Dispute Resolution procedures
  • CVM Program Policy and Procedures (P&P) Manual
  • Research Studies Criterion
  • Import Detention
  • Freedom of Information Act (FOIA)
  • AAFCO Standards
  • Agency Good Manufacturing Practice (cGMP) Initiative
  • Animal Supplement Labeling
  • Antimicrobial Resistance
  • VMAC Information
  • CVM Compliance Policy Guides (CPG)
  • Drug Product Listing
  • Drug Residue Tolerances
  • Freedom of Information Act (FOIA)
  • GMP Inspections
  • Good Laboratory Practices (GLP)
  • Federal Food, Drug and Cosmetic Act
  • BSE Feed Ban Rule
  • Rx/OTC Classification
  • Other

The complaints and inquiries handled by the Ombudsman involved the Offices in CVM directly or indirectly as follows:

OSC (includes referrals from OMAC/OD/CDER/OO62%
ONADE9%
OD19%
Other (outside CVM)10%

The types of complaints/concerns (49% of total) received that were related to the science or policy issues were as follows:

Adverse Drug Experiences (ADEs)/Reports31%
Feed/Food safety23%
Timeliness in review/response to submissions, letters, phone calls or e-mails11%
Internal CVM policy/decisions9%
Availability of important veterinary drugs5%
Delays in release of detained products5%
Illegal marketing/use of drugs5%
Issues with CVM employee/staff4%
High cost of vet drugs/services3%
Public information post-inspection3%
Direct-to-consumer advertising1%
GMP issues1%

Resolution of Complaints and Inquiries

Of the 165 complaints and inquiries received by the Ombudsman ninety-seven percent (97%) were resolved or referred and three percent (3%) of which are still pending or unresolved as follows:

Handled directly by the Ombudsman61%
Handled with referral to Center staff for follow-up9%
Referred directly to CVM staff, other Center/Agency30%
Still pending2%
Unresolved1%

Systemic Issues

Overall, the complaints and inquiries received/handled by the Ombudsman reflected primarily three issues as follows:

  1. Adverse Drug Experience (ADE) Issues

    There were more concerns and complaints about the reporting of adverse events, how CVM evaluates the reports and the availability of the evaluations on individual cases. Concerns were also expressed with regard to the Center’s follow-up action on specific products where the ADEs were perceived as serious and numerous. The Center’s staff and the CVM website provided the procedures for reporting ADEs and for requesting the evaluation of individual reports under the Freedom of Information Act (FOIA). Additionally, explanations were provided on the purpose of the ADE database system, the evaluation process, how to interpret the information in the database and how CVM monitors that information.

    Recommendation: The Center should consider providing information on ADE reporting in a reader friendly format such as a “Information for Consumers” flier.

  2. CVM’s Implementation/Interpretation of Updated and New Policies

    The Center’s implementation and interpretation of updated and new policies (e.g. Compounding CPG and Animal Drug User Fee Act) were questioned andchallenged procedurally and from the standpoint of their the impact on specificstakeholders. These issues were responded to utilizing the dispute resolution process and addressed to the complainants in follow-up action directly by CVM or indirectly through another FDA office. Also the appropriate CVM staff have been designated as the Center’s contacts for information and guidance on these issues.

  3. Timeliness in response to submissions, phone calls and e-mails

    This issue is a carryover from previous annual reports. The complainants requested the Ombudsman to intervene on their behalf due to persistent or unexplained delays in the review of submissions or no response to inquiries made via phone calls or e-mails on the status of information submitted for review. The Ombudsman exercised shuttle-diplomacy to obtain and provide the status of the submissions and to advise the complainants as to when to expect a response/action on their specific issues.