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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM OMBUDSMAN ANNUAL REPORT 2001

by Marcia Larkins, D.V.M.
FDA Veterinarian Newsletter 2002 Volume XVI, No IV

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 recurrence of specific issues or problems that may have an impact on Center policy and makes recommendations for change or improvement.

This report provides an overview of the Ombudsman's activities for the calendar year 2001.

General Categories and Subjects

The complaints and inquiries handled by the CVM Ombudsman during 2001 can be categorized generally as: complaints concerning specific products that were approved by or granted regulatory discretion by CVM; complaints/comments about existing FDA/CVM policies or administrative procedures and their impact on the public, academia, research, and private industry; inquiries and questions about FDA policy regarding specific issues/products; and requests for general information on the review/approval process. These categories covered the following subjects/areas:

  • Approved veterinary drugs
  • Contacts/resources in FDA/CVM and other Agencies
  • Cooperative Research and Development Agreement (CRADA)
  • CVM Home Page o CVM policy/administrative process
  • INADs/NADAs
  • Drug exportation
  • Drug Master File (DMF)
  • Drug shortage/withdrawal
  • Extra-label use policy (human and veterinary drugs)
  • FDA personal import policy
  • Freedom of Information (FOI) summary
  • MOU
  • Regulatory discretion
  • Regulations and guidelines
  • Veterinary colloid solutions
  • Wildlife drugs
  • VMAC

There were a total of 88 complaints and inquiries handled by the CVM Ombudsman during the 2001 calendar year, which is a 38% increase over the number for the year 2000. 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 or within FDA. However, several of the complaints or inquiries were referred to the Ombudsman from within CVM (28%), another Center Ombudsman (5%), and the Office of the FDA Ombudsman (1%). The Ombudsman was also contacted directly by e-mail, telephone and regular mail (66%).

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 2001 for the subjects/areas listed above, involved one or both issues as follows:

  • Regulatory discretion process 55%
  • Extra-label use requirements 10%
  • Policy/administrative process 11%
  • Pre-approval data requirements 6%
  • Center contacts/resources for specific issues 3%
  • Drug approval status 3%
  • Import/export for approved/unapproved drugs 2%
  • Post-approval issues 2%
  • Archived VMAC information 2%
  • Enforcement of regulations versus guidelines 2%
  • Drug shortage issues 1%
  • Pending human drug approval 1%

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

  • Office of Surveillance & Compliance 66%
    (includes referrals from OMAC/ONADE /CDER)
  • Office of New Animal Drug Evaluation (ONADE) 22%
  • Office of the Director (OD) 5%
  • Office of Management and Communications (OMAC) 2%
  • Other (outside CVM) 6%

The types of complaints/concerns (59% of total) received in relation to the science or policy issues were as follows * :

  • Unavailability of or delays in getting veterinary drugs due to shortage or due to withdrawal of human drugs 52%
  • High cost of drugs marketed under regulatory discretion 10%
  • Timeliness in review/response to submissions, letters, phone calls or e-mails 8%
  • Misinformation in veterinary publication 6%
  • Delays in the approval process 4%
  • Concern regarding possible retaliation 4%
  • Use of unapproved drug by practicing veterinarian 2%
  • Inconsistency between regulations and guidelines 2%
  • Changes in policy during the review/approval process 2%
  • FOI summary data and extra-label use 2%
  • Data requirements 2%
  • High cost of veterinary drugs inside as compared to outside the U.S. 2%

* individual complaint may represent more than one party

Resolution of Complaints and Inquiries

Of the 88 complaints and inquiries received by the Ombudsman 88% were resolved or referred while 13% are either pending or unresolved as follows:

  • handled directly by the Ombudsman 73%
  • follow-up action by Center staff 10%
  • referred to CVM staff, other Center or other Agency 5%
  • follow-up still pending 1%
  • unresolved 11%

Systemic Issues

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

  1. Regulatory/enforcement discretion process
    Many of the questions and complaints (55%) involved some aspect of the regulatory/enforcement discretion process. This issue is a carry-over from the year 2000, and it increased by 7% in 2001. Human drugs used in veterinary medicine have been withdrawn from the market and approved veterinary drugs have become unavailable for various reasons such as evidence of adverse reactions, manufacturing problems, and marketing decisions. The withdrawal of drugs approved for humans that are also used by veterinarians to treat conditions in animals that are life-threatening or where the lack of treatment results in a serious negative impact on the animal's quality of life, has been increasing for several years. These drugs have become unavailable with little or no warning leaving veterinarians and pet owners frantic for alternative resources. The owners dreaded the idea of having to consider euthanasia for a treasured pet that with proper treatment could live a fairly normal life. The drugs may have been removed from the market by the FDA based on evidence of life-threatening adverse reactions in humans or by the sponsor based on adverse reactions or due to certain marketing considerations.
  2. Timeliness in response to data submissions, letters, phone calls or e-mails
    This issue is also a carry-over from the year 2000 and the incidence remained about the same in 2001. The complainants' primary concerns were the lack of response to direct inquiries about the status of a current submission and after a specific timeframe or due date had passed.
  3. Approval Process
    Complainants expressed frustration in moving things through the approval process in general and because of changes in definitions and in policy based on "new information" that occur repeatedly during the review process in spite of prior documented commitments.
  4. Retaliation
    While there were no direct accusations of retaliation, the complainants expressed reluctance to pursue resolution of their issues even via an informal process due to concerns that it might impact the handling of current and/or future submissions. The Ombudsman's page at the CVM web site includes information on the Agency's policy on retaliation and how to report it.

Dr. Larkins is CVM's Ombudsman.