2006 Annual Report
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 2006.
General Categories and Subjects
The issues handled by the CVM Ombudsman during 2006 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 FDA/CVM policies, 3) inquiries and questions about FDA policy regarding specific issues/products, and 4) requests for general information on the personal import policy process and how to report adverse events. These categories covered the following subjects/areas:
- Adverse Drug/Product Events
- Animal Dietary Supplements
- Animal Feeds/Additives
- Animal Growth Promoters
- Aquaculture (food and additives)
- Dispute Resolution Process
- Drug/Product Importation
- Drug Compounding
- Drug Use in Minor Species
- Drug Import/Export
- Extra-label Use
- Fluoroquinolone Sensitivity
- Freedom of Information (FOI) requests/process
- Internet Drug Sales/Pharmacies
- Manufacturing Issues
- Pet Food and Product Recalls
- Pre-Market Classification/Status
- Product Jurisdiction
- Salmonella in Pet Turtles
- User Fees
- Veterinary Devices
- Veterinary Practice Ethics
- Veterinary Research
There were a total of eight cases and 136 complaints and inquiries handled by the CVM Ombudsman during the 2006 calendar year. All of these originated outside the Center from consumers, scientists and other professionals, private industry and other Offices/Centers within FDA. Some of the complaints and inquiries (4.9%) 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 2006 for the subjects/areas listed above, involved one or both issues as follows:
- ADE Reporting Procedures/Data base
- Animal Medicinal Drug Use and Clarification Act (AMDUCA)
- Animal Drug vs. Device Classification
- Animal Drug User Fee Act (ADUFA)
- CFR Residue Tolerances
- Citizen Petition
- Compounding of Drugs for Use in Animals (CPG section 608.400)
- Bioequivalence Waivers Policy
- Data Requirements (NADA/ANADA)
- Dietary Supplement Health and Education Act (DSHEA)
- Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (GFI # 79)
- Drug Registration and Listing Instructions (CDER)
- FDA Personal Import Policy
- FDA Policy for Regulating Veterinary Devices
- Freedom of Information Act (FOIA)
- Good Manufacturing Practices (GMPs)
- Homeland Security Act (hay transport regulations)
- Informal Opinion/No Objection Letter
- Import Certificates
- Minor Use Minor Species (MUMS) Act
- MOU Drug/Product Jurisdiction (CVM/EPA)
- Regulatory Discretion
The complaints and inquiries handled by the Ombudsman involved the Offices in CVM/FDA directly or indirectly as follows:
|Outside CVM (FDA)||23.6%|
The types of complaints/concerns (51% of total) received that were related to the science or policy issues were as follows:
|Adverse Drug Events (drugs, pet food, devices)||32.4%|
|Timeliness in review/response to submissions, letters, phone calls, or e-mails||18.9%|
|Pet food product quality||16.2%|
|Compounding and Internet Drug Sales||8.1%|
|Manufacturing and Marketing Issues||4.1%|
|User Fee Requirements||2.7%|
|Pet Turtles Sales||2.7%|
|Food safety (drug residues)||1.4%|
|Drug availability for minor species||1.4%|
|Website information accessibility||1.4%|
Resolution of Complaints and Inquiries
Of the 144 complaints and inquiries handled by the Ombudsman ninety-seven percent (97%) were resolved or referred and three percent (3%) are still pending or unresolved as follows:
|Dispute Resolution Process||4%|
|Handled by the Ombudsman||24%|
|Handled with referral to Center staff for follow-up||32%|
|Referred directly to CVM staff, other Center/Agency||40%|
Overall, the complaints and inquiries received/handled by the Ombudsman reflected primarily the following issues:
Adverse Event Issues
Consumer complaints and questions concerning the recent investigations of adverse events associated with certain products regulated by CVM. Many consumers are also concerned about the general quality of some pet food products sold in grocery stores and in pet stores due to personal observations, recent recalls and information available on the internet.
The callers are advised on the how to report their concerns and routed to the proper channels outside the Center. Additionally the home page has been updated and expanded to provide guidance on how report their concerns.
Timeliness in response to reviews, phone calls and e-mails, etc
Time delays in response to inquires are most often due to prioritizing with respect to work load.
Due to the increasing complexity of the data submitted for review, the Center has revised its policy and changed the classification of informal submissions. The reclassification provides a statutory timeframe and places the submission into the queue for formal review.
There were several complaints from consumers concerning the status of ADE reports and delays in response to their FOIA requests for CVM’s reviews of these reports.
Stakeholders complained about the interpretation and implementation of policy by CVM. The complainants utilized the informal dispute resolution process to resolve their specific issues. The Center staff presented information to demonstrate its consistency in handling these issues.
Ongoing public concern issues
- Pet turtles being sold in kiosks at some shopping malls and in some pet stores.
The sale of meat and milk from cloned animals.
The Ombudsman received over 4,000 “write-in” e-mails concerning this issue.
- The sale of prescription drugs being advertised and sold on the internet without any veterinary intervention.