2006 Annual Report

The Association of Veterinary Biologics Companies (AVBC) began its second decade as the major voice of veterinary biologics to CVB, and continued its successful representation of the biologics industry.

 Domestic Issues

Two procedural subjects dominated the domestic issues in veterinary biologics in 2006:  (1) funding for CVB and all of APHIS, and (2) wholesale adoption of the “draft notice” procedure to update regulatory policy. These topics are interrelated, at least in the eyes of the government, and the effects of change may be felt for a number of years. AVBC has taken a number of initiatives to influence these and other challenges and changes in 2006.

USDA Funding.  In the spring of 2006, Dr. Richard Hill told the AVBC meeting that CVB has been in a tightening budget squeeze for several years. He announced that contingency plans for restructuring the Center for Veterinary Biologics operations were being developed. On September 18, AVBC representatives participated in a meeting of top CVB officials and biologics industry representatives hosted by Dr. John Clifford, Deputy Director for Veterinary Services. APHIS convened the meeting to open up discussion of the resources available to CVB in fiscal year 2007 and 2008. In a dramatic gesture, CVB cancelled the Veterinary Biologics Public Meeting scheduled in March 2007. CVB is exploring the idea of implementing user fees or adopting GMP regulations, and has already discontinued their annual public meetings.

Late in 2006, AVBC leaders began plans to develop recommendations on CVB priorities, and the activity has developed momentum in 2007. AVBC works with allied groups on issues such as appropriations, and the association is an active participant in the Animal Agriculture Coalition (AAC), which develops consensus recommendations for the livestock industry on Capital Hill.   

Autogenous Product Licensing Period.  In 2005 and early 2006, a number of AVBC members in the swine and poultry products business informally petitioned CVB to agree to an interpretation of the autogenous product regulations which affords more flexibility in extending the life of products derived from an isolate. CVB agreed to work with industry on this, because amending the regulations or guidelines would be awkward at best. The issue was “resolved” with the understanding by all parties that the licensee must develop a potency test to be used for serial release. The potency test must be correlated to efficacy, but CVB indicated flexibility in how this is achieved.

Biometrics.  Frustration and confusion with the rules and principles that were being applied in the statistical analysis of studies were widespread at the AVBC annual meeting in 2005. A set of recommendations for changes and transparency in four specific areas was submitted to Drs. Rippke and Hill in early 2006. There was an AVBC/CVB meeting on the subject in February, with an AVBC follow-up letter. Dr. Rippke provided oral and written responses in April. In addition, CVB has increased the Biometrics staff, and Dr. Rippke stated that he hopes that this will eliminate any bottleneck caused by statistics questions. It remains to be seen whether these changes will improve the communications between reviewers and firms on the statistical basis for rejection of studies submitted by firms. The level of concern of AVBC members remains consistently strong and widespread on this issue. Biometrics will continue to be an important issue.  

Electronic Serial Release.  One of the issues that arose during the April AVBC meeting was the problem of a time lag in notice to a firm that a serial has been cleared for distribution. AVBC President Bob Tully put the recommendation for a faster notice procedure in a letter to CVB Director Steve Karli in June, and the letter was followed up with a conference call meeting on July 24, 2006. The following was agreed to as an interim measure: When a serial is really in short supply, and the customers are waiting for the shipment, CVB is willing to notify a licensee by telephone.

Assessing Pandemic Flu Vaccine Capabilities.  We all watched the news reports on the incidence of avian flu around the world, and APHIS was actively stockpiling vaccine in 2006. AVBC publicized to members CVB’s solicitation of bids for production of vaccine for the veterinary stockpile. On several occasions, AVBC reminded government officials of the substantial disruption of the veterinary biologics industry in 2003, when everyone in Veterinary Services was sent to California to fight a Newcastle disease outbreak. Even CVB reviewers were detailed to the West, and licensing and testing program in CVB practically came to a standstill. We were assured by APHIS officials that that would not happen again.

In Vitro Testing.  CVB published a draft notice (No. 019) which offered to provide to licensees standard reference bacterins for Leptospira grippotyphisa and Leptospira icterohaemorrhagiae in dogs, and it sets out a proposed procedure for licensees to qualify an ELISA assay as the serial release test using the new reference bacterins – or, if appropriate, the licensee may qualify another reference bacterin. AVBC filed comments in support of the proposal.

ALV Testing Notice.  In 2003, evidence came to light that the standard assay in 9 CFR was not detecting at least one strain of avian leukosis virus contamination in vaccines. AVBC organized a meeting of poultry producers, vaccine producers, and government regulators and researchers in the summer of 2003 to exchange information on the problem. APHIS’s investigations resulted in the development of a SAM which was published for comment in November 2006, along with Draft Notice No. 020 setting forth the procedure. 

Proposed Revision of VS Memo on Antigen Interference/Component Interference.  CVB published a proposed revision of VS Memo 800.203 “General Licensing Considerations: Antigen Interference” in late January 2006, containing a new section on study design and a new name: “General Licensing Considerations: Component Interference.” A new draft with further revisions was published for comment in late August with a few changes in response to earlier comments. AVBC circulated the two proposals to members, but no comments were developed. The revised document was published in final in January 2007.  

VS Memo 800.204 Rewrite.  CVB published a proposed revision of VS Memo 800.204, “General Licensing Considerations: Field Safety Studies,” which included extensive changes in the required or recommended protocols. AVBC’s comments were dominated by questions, because the purpose of the changes was not evident, and the draft Memo contained no background explanations. A revised “final” version of 800.204 was published in March 2007, reflecting the adoption of a number of the AVBC points.

 Additional CVB Draft Notices.  The draft notices kept coming in 2006. AVBC continued to notify members when new ones were published, but a number of them were not commented on, including the following:

International Issues

VICH Guideline Projects Progressing.  AVBC continues to have a role in the VICH harmonization program with representation as an Interested Party on the VICH Steering Committee. One Steering Committee meeting was held during 2006, and John Thomas attended as the AVBC representative. The Steering Committee manages the process and selects the topics, and the draft guidelines are developed by Expert Working Groups containing industry and government representatives from the three regions (the United States , the European Union, and Japan ).

The VICH Pharmacovigilance Expert Working Group has been working for a number of years to prepare a group of five guidelines covering the different aspects of the subject. Two of the guidelines were published worldwide for public comments in 2006, and AVBC submitted comments through APHIS. AVBC’s comments covered two principal issues in these proposals. First, the definition of “adverse event” is too broad, because it fails to require any connection between the medicinal product and the bad result, and it fails to limit the reporting to unexpected adverse experiences. Second, AVBC recommended that licensees submit summary reports to the agency, with the data on specific incidents available upon request, but the proposed guidelines do not recognize this concept. In the other regions of the world, this data is routinely kept confidential by the regulatory authorities, but in the U.S. it is subject to disclosure under the Freedom of Information Act.

Association Matters

AVBC 2006 Meetings.  AVBC held a business meeting at the Hotel Fort Des Moines in Des Moines , Iowa in April. The CVB leadership, Dr. Hill, Dr. Rippke, and Mr. Karli, addressed the Association regarding concerns of interest to AVBC members including biometrics, proposed labeling regulations, pharmacovigilance, in vitro tests, and the National Center for Animal Health (NCAH). AVBC members took action on several subjects discussed above, including biometrics, electronic serial release, and APHIS funding. At the reception on the evening of April 19, recognition was given to John Mitzel who retired after 18 years of service with CVB-IC, most recently serving as Inspection Section Leader.

The AVBC Annual Meeting was held in October in conjunction with the United States Animal Health Association (USAHA) and American Association of Veterinary Laboratory Diagnosticians (AAVLD) meetings in Minneapolis , Minnesota . The venue gave AVBC members the opportunity to attend USAHA committee meetings, including the Committee on Biologics and Biotechnology (B&B), where an update was provided by Dr. Rick Hill, as well as reports on current disease programs and APHIS regulation of transgenic animals.

During the AVBC business meeting on October 17, participants were provided with updates on a number of current issues and some speculation on subjects that may arise in the future. Dr. Sebastian Heath outlined the status of the homeland security network and resources related to agriculture industries, and John Thomas reported on two subjects that are gaining momentum on the international scene – laboratory animal welfare and regulation of biotech products. Participants honored Majon Huff of Colorado Serum Company for his many years of outstanding leadership in the veterinary biologics field. Unfortunately Mr. Huff was unable to attend but the tribute was shared with him via videotape.

In the business meeting, Joe O’Donnell of IDEXX Laboratories and Ted Girshick of Charles River Laboratories were re-elected as Treasurer and Secretary, respectively. Bob Tully and Dave Carney began the second year of their terms as President and President-Elect, respectively.

Communications.  AVBC published seven issues of the members’ newsletter, AVBCurrent, during 2006. AVBC adopted positions and submitted comments and recommendations on eight regulatory proposals during the year, each of which involved several rounds of e-mails with member companies to develop and refine positions. AVBC’s Executive Committee met eight times, twice in connection with the two association meetings and otherwise by conference call. Minutes of all meetings of the Executive Committee, as well as the membership meetings, were distributed to all members.

Membership.  At the close of 2006, AVBC membership includes 16 active members and 11 associate members.

 2006            

Annual Report

2008