2001 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 2001.
General Categories and Subjects
The complaints and inquiries handled by the CVM Ombudsman during 2001 can be categorized generally as 1) complaints concerning specific products that were approved by or granted regulatory discretion by CVM, 2) complaints/comments about existing FDA/CVM policies or administrative procedures and their impact on the public, academia, research and private industry, 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:
- Approved veterinary drugs
- Contacts/Resources in FDA/CVM and other Agencies
- Cooperative Research and Development Agreement (CRADA)
- CVM homepage
- CVM policy/administrative process
- 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
- Regulatory discretion
- Regulations and Guidelines
- Veterinary colloid solutions
- Wildlife drugs
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 1) within CVM (28%), 2) another Center Ombudsman (5%) and 3) 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%|
|Pre-approval data requirements||6%|
|Center contacts/resources for specific issues||3%|
|Drug approval status||3%|
|Import/Export for approved/unapproved drugs||2%|
|Archived VMAC information||2%|
|Enforcement of regulation 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:
|OSC (includes referrals from OMAC/ONADE/CDER)||66%|
|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 vet. 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%|
|High cost of veterinary drugs inside so compared to outside the United States||2%|
* individual complaint may represent more than one party
Resolution of Complaints and Inquiries
Of the 88 complaints and inquiries received by the Ombudsman eighty-eight percent (88%) were resolved* or referred while thirteen percent (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%|
*At least one potential lawsuit and two potential Congressional inquiries were avoided by resolving these complaints informally through Ombudsman intervention.
Overall, the complaints and inquiries received/handled by the Ombudsman reflected primarily four systemic issues as follows
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 seven percent (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.
A few of the complainants on this issue offered the following suggestions
- Make the drug available by veterinary prescription in the short run. In the long run create an advisory committee to inform the FDA of the implications that its decisions have on pets before taking something off the market. The FDA should remember that humans are not the only lives that are affected by these decisions.
- The FDA should be balancing the usefulness of drugs against the risks instead of focusing on the risks and being indifferent to the benefits.
- The FDA should be vigilant in alerting the public to the risks of drugs, but it should be very circumspect about banning a drug entirely. Consumers need to make informed decisions about drugs for themselves and for their pets.
Additional complaints/comments were made about the length of time for a withdrawn human drug to become available for veterinary use and about the substantial increase in cost when marketed under regulatory discretion. The Center should consider sending out “Updates” on a case-by-case basis as these incidents occur. The “Updates” would provide a detailed explanation of enforcement discretion, its implications, limitations and CVM’s role in that process.
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 1) to direct inquiries about the status of a current submission and 2) after a specific timeframe or due date had past.
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.
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 website includes information on the Agency’s policy on retaliation and how to report it.