Representing Manufacturers of Veterinary Vaccines & Other Biological Products
Representing Manufacturers of Veterinary Vaccines & Other Biological Products
2008 Annual Report
Issues
No Boost in CVB Funding for 2009 in Initial Action.
On July 17, the Senate Appropriations Committee reported the FY 2009
appropriations bill for USDA and related agencies. Following the
pattern of recent years, the Senate committee gave the Center for
Veterinary Biologics only a skimpy cost-of-living raise—a 2.3
percent increase from $16.541 million to $16.922 million. Overall,
USDA’s funding would increase more than 7 percent if this bill were
enacted, but APHIS would see a $6 million decrease in its
funding (from $867 million to about $861 million). Contrary to
tradition, the Senate committee acted before the House committee.
The House Appropriations Committee had scheduled mark-up of the USDA
appropriations bill for late June, but that was cancelled at the
last minute, and it is not certain that the mark-up will be held
before Congress’s August recess. The Committee keeps its
recommendations more or less secret until the report of Committee
action is published. The fiscal year starts October 1, but the
conventional wisdom is that no appropriations bills will be passed
on time this year. If not, as in the past several years, Congress
will pass a “continuing resolution” which allows the federal
agencies to continue to operate at last year’s funding level until
the regular bills are passed. For FY 2008, the legislation was
passed a couple days before Christmas.
Target Animal Batch
Safety Testing Guideline: In late June, the European
Medicines Agency (EMEA) circulated a proposal for a new biologics
topic, which AVBC members were asked to comment on. The proposal was
to develop a guideline on the use of target animal batch safety
tests, with the stated goal of reducing the use of the test in order
to reduce the use of animals. The informal poll of AVBC members
found both support and opposition to use of animals in batch safety
tests as a general concept. If the lab animal test would be replaced
by an in vitro test, the costs could be a problem. If there
is no release safety test, that may be an unacceptable risk for the
animals which will receive the product.
Although the proposal was specific to target
species safety tests, the EU proponents were uncertain
whether the proposal was intended to cover lab animal tests as well.
And there were differences of opinion on whether this would affect
current U.S. product requirements. There was sufficient interest
that EMEA was asked to write a concept paper to define the scope and
goals of the guideline. This draft concept paper will be circulated
for comment this fall; the plan is to have a final paper to vote on
at the Steering Committee meeting in February. If approved, the
Biologics Quality EWG could get to work on the guideline during
2009.
Mycoplasma Test Procedure: For a
decade, the Biologics Quality Monitoring EWG has been trying to
develop a guideline on testing vaccines for mycoplasma
contamination. The effort has been hindered by problems producing
the reference organisms, and the Americans and Europeans could not
agree on a study protocol. It appears that this has all been sorted
out and, this fall, a protocol will be adopted, and the reference
materials will be distributed to the participants to validate the
protocol.
Guideline on Target Animal Safety Testing for
Biologics: The Steering Committee adopted the final version
of this guideline (GL 44), which was circulated in draft form in
2007. Presumably, CVB will now publish this as a proposed VS
Memorandum.
2008 CVB published VS Memoranda.
General Licensing
Considerations:
Backpassage Studies.
This is a replacement of VS Memorandum 800.201.
The text is little changed from the year 200 version which it
replaces, except that the new version notes the adoption of BICH
Guideline No. 41 on this subject.
The Memo states that CVB will accept studies which comply
with VICH GL 41 as well as the Memo.
The old VS Memo included a table and a graph on probability
of re-isolation; this is probably intended to be attached to the new
Memo, but the version on the CVB website does not have these
attachments or the VICH guideline.
CVB also published CVB Notice 08-13, dated July 23, 2008, which
serves as a summary of the agency’s responses to the public comments
that were submitted when the proposed guideline was published in
late 2004.
Guidelines for Validation of In Vitro Potency Assays.
This is a new VS Memo 800.112, based on Memo Draft 110, which was
originally published in March, 2007.
A principal criticism of the Draft 110, delivered by AVBC and
others, was that the Draft Memo to a large extent assumed that the
assays would be done with the ELISA method.
This prompted CVB to draft a new document which describes the
elements on an analystical method.
The new draft was published in September 2007, and it
received another round of comments from AVBC and several companies.
The final of VS Memo 800.112 retains the philosophy of
general guidance, with the expectation that there will be other
memos for specific analytic methods.
It appears that a number of the industry suggestions were
accepted.
GB Texas Newcastle Disease Challenge Virus.
CVB published an updated version of VS Memo 800.95 to reflect the
change in the regulatory status of the virus – it was classified as
a select agent last year, so the strain can be possessed only by
companies which have registered under the select agent program.
Master Seed at Alternate Locations.
APHIS has published new VS Memorandum No. 800.113, “Production,
Testing and Storage of Master Seed and Master Cell Stocks at
Alternate Locations.” The Memo provides guidelines on documentation
and handling Master Seed and Master Cell Stocks which are obtained
from premises other than the licensed facility (including imports).
This “final” Memo incorporates some changes from the draft published
a year ago; most of the changes seem to emphasize the licensee’s
responsibility for the integrity of the materials.
Food
Animal Residue Avoidance Databank (FARAD).
In August 2008, the American Veterinary Medical Association took the
initiative to lobby for emergency funding for the Food Animal
Residue Avoidance Databank (FARAD), a university-based consortium
which gathers, analyzes, and reports on animal drug residue
avoidance information.
The program, started in 1982, has been erratically funded as an
earmark in the appropriations for the Center for Veterinary
Medicine, but federal funds dried up as a result of the earmark
“reform” in 2007, and the universities are cutting off subsistence
funds for the databank as of September 30, 2008.
As a member of the Animal Agriculture Coalition, AVBC was
asked to endorse this request, and the AVBC Executive Committee
approved the action.
Thus, AVBC’s name was included on the letters from AVMA to members
of Congress. Update:
Donations from several organizations kept FARAD running until
early 2009, when it received an $806,000 Congressional
appropriation. This
amount is expected to sustain the program until the end of the year,
without additional layoffs.
Discontinued Reagents.
The CVB announced that it will no longer supply licensees with the
GB Texas strain of Newcastle
Disease Virus, in CVB Notice 08-14, dated July 23, 2008.
The policy was effective immediately.
CVB stated that its supply is depleted, but the virus is
available from the National Veterinary Services Laboratory and
private sources.
CVB recently published Notice No. 08-16, announcing that
Feline Rhinotracheitis
Challenge Virus is no longer available from CVB. This was
effective as of the date of the Notice, September 3, 2008.
A licensee’s reviewer should have information regarding
alternate sources.
Debate on National Bio- and Agro-Defense Facility (NBAF).
The plans of the Department of Homeland Security to build the NBAF
revisited the news in August 2008, as the possible neighbors begin
to look at the implication of have these exotic disease organisms in
their backyards. A
report by the Government Accountability Office released in May 2008
stated that DHS has not done a “true” assessment of the risks of
bringing the FMD virus and other exotics to the mainland.
Additionally, on August 14, 2008, it was reported that DHS
has confirmed plans to close the Plum Island facility when the new
NBAF is completed, drawing a mixed reaction from Plum Island’s
neighbors.
Animal Drug User Fee Legislation Renewed and Expanded.
On August 14, 2008, President Bush signed the Animal Drug User Fee
Act Amendments (ADUFA II), extending the fee program for 5 years.
The legislation increases the total CVM can collect each year for
the existing new animal drug categories, and it authorizes CVM to
collect fees for generic animal drug applications and registrations,
as well. The fee in fiscal year (FY) 2007 was $168,600 for a new
animal drug application, rising to $172,500 in FY 2008. There are
also product fees, establishment fees, and sponsor fees. The rates
have not yet been set for FY 2009, but the totals suggest that fees
could jump. For FY 2008, CVM was authorized to collect a total of
$11,600,000 from the various categories of fees. For FY 2009, the
new legislation permits CVM to collect $15,260,000 for new animal
drugs plus, for the first time, CVM can collect fees for
generic drug applications in the amount of $4,831,000. In the final
year, CVM is authorized to collect up to $24,244,000 in new animal
drug fees and $6,031,000 in generic animal drug fees. The Senate
appropriations bill for FY 2009 would appropriate $71,824,000 for
CVM operations, to be supplemented by $15,260,000 in user fees.
D361
Comments Filed.
The comments on D361 (proposed revisions to the Administrative
Inspection Review process) have been submitted to CVB by John
Thomas. Two brief points were made. First, we indicated AVBC’s
support for the proposed changes to reduce the reporting burden.
Second, AVBC expressed a need for more guidance from CVB before it
implements its proposal to add a “focus question” on the status of
expiration dating of licenses products.
Extension of Dating.
In July 2008,
CVB published Biologics Notice No. 08-15 ,announcing the extension
of the dating of two standard reference bacterins.
The Salmonella typhimurium Standard Reference Bacterin
Lot No. IRP 460 is extended until June 30, 2009, and the
Salmonella dublin Standard Reference Bacterin IRP SDB-3 is
extended to September 30, 2009. In
each case, the extension will expire if a new reference is
qualified.
At the end of 2008, CVB published Biologics Notice No. 08-20,
extending the dating on Pasteurella Multocida standard reference
bacterins, while the laboratory completes the validation of new
references. The Notice
also states that for the Salmonella Choleraesuis bacterin, CVB is
evaluating the maintenance of the bacterin.
Association Matters
AVBC welcomed new members.
At
its April 7, 2008 business meeting in Ames, Iowa, AVBC welcomed
three new members.
Immucell Coporation, of
Portland, Maine, joined as an Active member;
Avipath, LLC, of Lenexa,
Kansas, joined as an Associate member; and
BioBuiness Consultants
of Galena, Illinois joined as an Independent Consultant.
Welcome!
At the September 17, 2008 annual meeting, the AVBC Membership voted
on the applications for five new members, welcoming Epitopix
of
Willmar, Minnesota,
Hygieia Biological Laboratories
of Woodland, CA,
and Sirrah-Bios Inc.
of Ames, Iowa, as
Active Members; and Espeseth Consulting
of Perkasie, PA
and John Mitzel Consulting
of Ames, Iowa, as
Independent Consultants, into our membership.
AVBC Officers.
AVBC
officers were elected at the fall business meeting.
Ted Girshick of Charles
River Laboratories will continue as President for the second year of
his term; Jeff Trunnell
of Fort Dodge Animal Health is the Vice President; and
Joe O’Donnell of IDEXX
Laboratories and Jerry
Chapman of Merial Select will continue as Treasurer and
Secretary, respectively.