About FDA

2002 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 2002.

General Categories and Subjects

The issues handled by the CVM Ombudsman during 2002 can be categorized generally as 1) complaints concerning the availability of specific important products regulated by CVM, 2) complaints/comments about the interpretation or implementation of existing 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 Experiences (ADE)
  • Animal feeds
  • Animal research
  • Aquaculture
  • Center contacts/direct referrals
  • Compliance issues
  • Contract research organization
  • Current legislation
  • Dietary supplements
  • Dispute resolution
  • Drug importation
  • Drug withdrawal/restricted use
  • EIR information
  • External requests for “Ombud” input
  • Extra-label use
  • Food safety/hygiene
  • Green Book
  • INAD/NADA process
  • International inquiry
  • Internet pharmacies
  • Manufacturing issues
  • Minor species
  • Neutraceuticals
  • Pet food/products
  • Proprietary trade names
  • Quality assurance
  • Veterinary biologicals
  • Veterinary devices
  • Veterinary research
  • VMAC

There were a total of 104 complaints and inquiries handled by the CVM Ombudsman during the 2002 calendar year which is a 16% increase over the number for the year 2001. The majority (91%) of these originated outside the Center from consumers, scientists and other professionals, private industry and other federal agencies. Only 9% of the inquiries originated from inside CVM. Several (14%) of the complaints or inquiries were referred to the Ombudsman either from within CVM, 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 2002 for the subjects/areas listed above, involved one or both issues as follows:

New Animal Drug det./data requirements 12%
Center resources for specific issues 12%
Regulatory discretion 10%
ADE reporting procedures/database 6%
Personal import policy 6%
AMDUCA 5%
MNVP 5%
Ombudsman function 5%
Product jurisdiction 4%
CVM research data 4%
Appeal/Mediation procedures 3%
Animal research criterion 2%
CVM/AVMA policy 2%
Drug expiration data extension 2%
AAFCO standards 1%
Agency cGMP initiative 1%
Animal supplement labeling 1%
Antimicrobial resistance 1%
Archived VMAC information 1%
Carcinogens 1%
Compounding 1%
Cloned animals 1%
Drug product listing 1%
Drug residue tolerances 1%
EIR information 1%
Freedom of Information Act (FOIA) 1%
GMP inspection request 1%
1% Good Laboratory Practices (GLP) 1%
Labeling 1%
Marketing unapproved product 1%
Pasteurized mild ordinance 1%
Other 10%

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

OSC (includes referrals from OMAC/OD/ONADE/CDER/OO 61%
ONADE4 20%
OD 12%
Other (outside of CVM) 8%

The types of complaints/concerns (47% of total) received in relation to the science or policy issues were as follows * :

Timeliness in review/response to submissions, letters, phone calls, or e-mails 16%
Adverse reactions in approved/unapproved (reg. discretion) drugs 16%
Communication problems (internal and external) 14%
Availability of important veterinary drugs 12%
Internal CVM policy/decisions 10%
Food safety/hygiene 6%
CVM/AVMA policy 4%
Human drug withdrawal/restricted use issues 4%
Accuracy of information in ADE reports 2%
Ban on medically necessary drug 2%
Drug price increases 2%
Facility inspection delay 2%
High cost of vet drugs inside versus outside the U.S. 2%
Illegal extra-label drug use 2%
Legality of drug use beyond expiration date 2%
Marketing of unapproved product 2%

* One of the cases accounted for two separate complaints

Resolution of Complaints and Inquiries

Of the 104 complaints and inquiries received by the Ombudsman ninety-two percent (92%) were resolved or referred and eight percent (8%) of which are still pending or unresolved as follows:

Handled directly by the Ombudsman 56%
Follow-up action by Center staff 19%
Referred directly to CVM staff, other Center/Agency 25%
Still pending 7%
Unresolved 1%
Systemic Issues

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

  1. Timeliness in response to data submissions, letters, phone calls or e-mails
    This issue is a carry-over from the year 2001 and has increased from 8% to 14%. The complainants requested the Ombudsman’s assistance when there was no response to repeated requests for submission status or after specific stated timeframes had past. Complainants were especially concerned if there was no response or acknowledgement when they considered their request to be an emergency.

    Recommendation: A follow-up response should be made to the complainant to acknowledge receipt of and to explain Center procedures for handling their pending letter, submission package, e-mail, etc. Emergency requests should be given the appropriate priority status.

  2. Adverse Drug Experience (ADE) Issues
    There were more concerns and complaints about potential and reportable adverse reactions occurring in drugs currently under regulatory discretion status than for approved drugs. This is a change from the previous trend (CVM Ombudsman 2001 Annual Report) which focused more on the process involved in making these drugs available for veterinary use. The Center’s staff and the CVM website provided adequate information on the ADE database system and procedures on how to report ADEs.
  3. Communication Problems
    The Ombudsman was requested to intervene for parties both inside and outside the Center due to difficulties encountered in communicating with a rude or difficult employee or outside caller. For these situations the Ombudsman exercised shuttle diplomacy or handled the administrative aspects of case with follow-up by the appropriate Center staff.
  4. Quality of Information Dissemination (QID) Issues
    The FDA Information Quality Guidelines became effective on October 1, 2002. The guidance describes the type of information disseminated by FDA and explains FDA’s standards, policies, and procedures for ensuring the quality of that information. It also explains the Agency’s administrative complaint procedures that are in place to enable persons to seek and obtain correction of information that they believe does not comply with the OMB and HHS guidelines and the FDA guidance.

    In 2002 there were 3 challenges to information disseminated by CVM that fit under the QID guidelines:

    1. the accuracy of the information in the ADE database
    2. the availability of certain “public” information on the home page
    3. CVM’s interpretation of the personal import policy

    Recommendation: In light of the new QID guidelines, the Center may want to consider adding a statement(s) regarding public availability/accessibility of specific information posted on the home page. The most frequent inquiries received by the Ombudsman in 2002 regarding information on the home page were about accessing CVM research reports followed by the ADE database.

 

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