Animal & Veterinary
CVM Ombudsman Annual Report 2002
by Marcia Larkins, D.V.M.
FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4
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 information presented in this article is a summary of the CVM Ombudsman’s Annual Report for 2002. The complete detailed report will soon be available on the CVM Home Page.
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. Nine percent (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.
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
- Animal Feeds
- Animal Research
- Center Contacts/Direct Referrals
- Compliance Issues
- Contract Research Organization
- Current Legislation
- Dietary Supplements
- Dispute Resolution
- Drug Importation
- Drug Withdrawal/Restricted Use
- Establishment Inspection Report (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
- Pet Food/Products
- Proprietary Trade Names
- Quality Assurance
- Veterinary Biologicals
- Veterinary Devices
- Veterinary Research
- Veterinary Medicine Advisory Committee (VMAC)
Overall, the complaints and inquiries received/handled by the Ombudsman reflected primarily four systemic issues as follows:
- 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.
- 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.
- 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 diplomacy and/or assisted in handling the administrative aspects of case with follow-up by the appropriate Center staff.
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 three challenges to information disseminated by CVM that fit under the QID guidelines:
- the accuracy of the information in the ADE database
- the availability of certain “public” information on the Home Page
- interpretation of the personal import policy
All calls and inquiries to the Ombudsman are confidential. For further information about the activities of the Ombudsman’s office, please visit the CVM Home Page. For printed copies of the full report, please contact Dr. Larkins at 301-827-4535.
Dr. Larkins is the CVM Ombudsman.