FDA to allow more drugs for nonfood minor species
The Food and Drug Administration is proposing regulations to implement the “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species” under the 2004 Minor Use and Minor Species Animal Health Act.
The index would make more drugs legally available to veterinarians for the treatment of nonfood minor species.
The FDA intends the index to be a means by which companies can legally market drugs for nonfood minor species without completing the long and expensive approval process. The index could also include drugs for some early life stages of food animals, such as fish eggs, that present no concerns for human food safety.
The FDA would base inclusion in the index on the findings of expert panels that would evaluate target animal safety and effectiveness of each product. The FDA proposal describes regulations for making determinations regarding the eligibility of animal drugs for indexing, regarding the selection of an expert panel, and regarding the findings of the expert panel.
The full proposal appears in the Aug. 22 Federal Register, available at www.gpoaccess.gov/fr/.
Parties may submit comments until Dec. 20 online at www.regulations.gov or www.fda.gov/dockets/ecomments; by fax to (301) 827-6870; or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The heading should include “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,” FDA, Docket Number 2006N-0067.
Information is available from Dr. Andrew Beaulieu, Center for Veterinary Medicine (HFV-50), 7519 Standish Place, Rockville, MD 20855; phone, (240) 276-9090; e-mail, Andrew.Beaulieu@fda.hhs.gov.
Court files order in pharmacies' case against FDA
Following an initial ruling from the bench in May, U.S. District Court Judge Robert Junell filed a court order Aug. 30 that addressed a handful of issues related to compounding drugs.
The case—Medical Center Pharmacy, et al. v. Gonzalez, et al. in the U.S. District Court for the Western District of Texas, Midland-Odessa Division—was filed in September 2004 by 10 state-licensed pharmacies against the Food and Drug Administration.
In the court order, Judge Junell ruled that compounded drugs, when created for an individual patient following a prescription from a licensed practitioner, are implicitly exempt from the “new drugs” definitions in the Federal Food, Drug and Cosmetic Act. Drugs that are compounded in large quantities before a prescription is received from a practitioner do not fall within the exemption.
Next, the court ruled that if pharmacies are compliant with local laws, dispense drugs following the receipt of prescriptions from licensed practitioners, and compound drugs in the regular course of their individualized businesses, the pharmacies are exempt from the FDA's enhanced inspection. An enhanced inspection allows the FDA to access not just the pharmacies' records, but any files, papers, processes, controls, or facilities if the pharmacies were engaged in certain designated activities. The court ruled that the FDA had not demonstrated that any of the 10 pharmacies involved in the case did not qualify for exemption.
Also of note, the court ruled that pharmacies may compound drugs for non-food-producing animals from legal bulk ingredients.
The court order drew distinction between pharmacists and veterinarians compounding from bulk ingredients for non-food-producing animals. Veterinarians were not afforded the same protection under the FFDCA that was given to compliant compounding pharmacies.
Animal rights militants for terror campaign
Members of a militant animal rights group sentenced to federal prison in September represent the first jury convictions for violations of the Animal Enterprise Protection Act. This law criminalizes certain conduct aimed at companies engaged in animal research and testing. The law equates harassment and intimidation with acts of terrorism and carries a maximum sentence of up to three years in prison and a $250,000 fine.
United States federal judge Anne E. Thompson also ordered the defendants, members of Stop Huntingdon Animal Cruelty USA Inc., and the entity itself to share in the payment of $1 million in restitution to Huntingdon Life Sciences. This research laboratory in New Jersey was the target of the activists' international harassment campaign.
Sentenced Sept. 12 were Kevin Kjonaas, Lauren Gazzola, and Jacob Conroy. Kjonaas, the former president of SHAC USA, was sentenced to 72 months in prison, Gazzola, the group's campaign coordinator, to 52 months in prison; and Conroy, a coordinator and SHAC USA's Web site manager, to 48 months in prison.
In separate hearings later that month, Joshua Harper, Andrew Stepanian, and Darius Fullmer were sentenced. Harper, SHAC USA's West Coast coordinator, and Stepanian, the organization's New York coordinator, each received a 36-month prison sentence, and Fullmer, received a one-year sentence.
In March, a federal jury convicted SHAC USA and the six members on all six counts against them for their roles in a campaign to terrorize officers, employees, and shareholders of Huntingdon. Activists used the same tactics against other companies and their employees for doing business with Huntingdon.
Huntingdon Life Sciences is an international research firm headquartered in the United Kingdom with an office in East Millstone, N.J. SHAC and its U.S. branch have been trying to force Huntingdon out of business for several years.
The stated goal of SHAC USA was to drive Huntingdon out of business through its direct action against the company and specific individuals. The animal rights group directed its campaign via its Web sites, where it posted and applauded acts of harassment, intimidation, vandalism, and violence against Huntingdon, its employees, and others.
At trial, the defendants attempted to disassociate themselves from the violent, threatening, and intimidating tactics of SHAC USA. They also argued that much of their conduct was protected free speech. The jury rejected these arguments in finding all the defendants guilty.
Funding available for PRRS research
Boehringer Ingelheim Vetmedica Inc. is seeking research proposals for studies investigating porcine reproductive and respiratory syndrome.
For the fifth year, the company will provide three $25,000 awards through its 2007 Advancement in PRRS Research Awards program to swine practitioners, diagnosticians, or researchers to investigate new ways to diagnose, control, and eradicate this costly swine disease.
An independent review board selects proposals on the basis of criteria that include economic impact on the swine industry, originality and scientific quality, and probability of success in completing the yearlong study.
The deadline for proposals is Jan. 1, 2007. Send a cover sheet, a one-page curriculum vitae for the primary investigator and each co-investigator, and two letters of recommendation to Boehringer Ingelheim Vetmedica Inc., Attn.: Trudy Luther, The Advanced PRRS Research Award, 5506 Corporate Drive, Suite 1600, St. Joseph, MO 64507-7752.
More information is available by visiting www.PRRSresearch.com, e-mailing firstname.lastname@example.org, or calling (800) 821-7467, ext. 2780.
Feline practitioners seek research proposals
The American Association of Feline Practitioners is seeking proposals for its 2007 research grant for feline medicine.
The AAFP will award $15,000 to the proposal that shows the most clinical merit. The research committee will give preference to funding complete projects, not precluding matching funds, and to nonterminal studies. The committee also will give preference to clinical studies of patients rather than research animals.
The deadline for submissions is Dec. 15 to AAFP, 203 Towne Centre Drive, Hillsborough, NJ 08844. The AAFP's contact information is email@example.com; phone, (908) 359-9351; fax, (908) 359-7619. Applications are available at www.aafponline.org under Resources, Research Grants.
Company gives grants for study of porcine circovirus
Boehringer Ingelheim Vetmedica Inc. has announced two recipients of a total of $75,000 in funding for three studies of porcine circovirus-associated disease.
The 2006 PCVAD Research Awards went to the following veterinarians:
• Dr. Darwin L. Reicks, Swine Vet Center, St. Peter, Minn., for “The effect of porcine circovirus type 2 (PCV2) vaccine on the prevalence of detection in serum, blood swab, and semen in adult boars”
• Dr. Tanja Opriessnig, Iowa State University College of Veterinary Medicine, for “Comparison of different PCV2-antibody ELISA assays and detection of PCV2-specific antibodies after vaccination or after infection with distinct PCV2-isolates” and for “Characterization and comparison of the immune response to PCV2 in pigs from different genetic origin”
An independent review board selected proposals on the basis of criteria including potential for economic impact to the swine industry, originality and scientific quality, and probability of success in completing the one-year study.
More information about the PCVAD Research Awards is available at www.PCVADresearch.com or by calling (800) 325-9167. The next deadline for proposals is July 1, 2007.
From the AVMA
AVMA welcomes nominations for 2007 awards
Members of the AVMA are invited to help select qualified recipients who are members of the AVMA for awards administered annually by the Association. The 2007 awards will be presented at the 144th Annual Convention of the AVMA, July 13–18 in Washington, D.C.
Nominations must be sent by Feb. 1, 2007, for the AVMA Award, AVMA Animal Welfare Award, Lifetime Excellence in Research Award, Meritorious Service Award, Practitioner Research Award, Public Service Award, Royal Canin Award, and XIIth International Veterinary Congress Prize. Send them to the AVMA Executive Division, 1931 N. Meacham Road, Suite 100, Schaumburg, IL 60173-4360.
Humane Award nominations must be received by Dec. 1, 2006, at the AVMA Communications Division, 1931 N. Meacham Road, Suite 100, Schaumburg, IL 60173-4360.
Nominations for the Charles River Prize must be sent by Feb 1, 2007, directly to the Charles River Laboratories Foundation, 251 Ballardvale St., Wilmington, MA 01887.
Nominees will be evaluated on their qualifications only. Letters seconding, endorsing, or supporting nominations for awards will not be used to evaluate candidates, except for the Lifetime Excellence in Research Award. For that award, letters of support are required from three individuals who are familiar with the nominee's work.
A curriculum vitae with bibliography must be attached to the nomination, and the nomination must include the following supporting data:
• name of the award
• the nominee's name, mailing address, office and home telephone numbers, and school/college and year of graduation
• organizational memberships
• honors or awards
• a 250- to 300-word biographic sketch
• a statement pertaining to qualifications for the award
• a portrait (digital images must be at 300 dpi or higher, and prints must be 4 inches × 5 inches or larger)
Background on each award can be found in the AVMA Membership Directory & Resource Manual or in the online JAVMA News for Oct. 15.
AVMA seeks veterinary leaders
Nominations are invited for 76 vacancies on AVMA entities and 14 liaison positions. The House of Delegates will fill council openings when it meets in July 2007 in Washington, D.C. The Executive Board will make liaison and committee appointments at its April 2007 meeting.
Nominating materials for councils—including instructions for publishing biographic sketches of the candidates in the 2007 Campaign Guide— were sent in August to AVMA delegates and chief staff officers of organizations represented in the HOD. Others may obtain council and committee nomination forms on the AVMA Web site, www.avma.org/about_avma/governance/default.asp, or by calling AVMA headquarters at (800) 248-2862, Ext. 6651 for councils, Ext. 6605 for committees.
Council nominations must be postmarked by Feb. 1, 2007, and sent to Dr. Bruce W. Little, AVMA executive vice president. Trust, committee, and board nominations should be postmarked no later than March 9, 2007, and sent to J. Karl Wise, PhD, AVMA associate executive vice president.
The Veterinary Community
Appointments, awards go to academics
Auburn University College of Veterinary Medicine has named Carl A. Pinkert, PhD, as associate dean for research and graduate studies and as a pathobiology professor. Previously, he has served on the faculty at the University of Rochester Medical Center and University of Alabama-Birmingham. Dr. Pinkert is a past editor of the journal Transgenic Research.
Dr. Egbert Mundt has become the first Caswell Eidson Chair in Poultry Medicine at the University of Georgia College of Veterinary Medicine. Previously, he was with the Federal Research Institute for Animal Health in Germany. Much of his research focuses on bursal disease and avian influenza. Dr. Mundt will help lead Georgia's efforts to develop avian vaccines.
Dr. Narda Robinson has received an endowment for a professorship in complementary and alternative medicine at Colorado State University College of Veterinary Medicine and Biomedical Sciences. Dr. Robinson founded the college's complementary and alternative medicine service. She is also a board-certified physician in medical acupuncture and heads the examination committee of the American Board of Medical Acupuncture.
Lorraine J. Hoffman, PhD, recently received the William P. Switzer Award in Veterinary Medicine from the Iowa State University College of Veterinary Medicine for contributions to the college that span nearly 40 years. Dr. Hoffman is a professor, microbiology researcher, and interim director of the Veterinary Diagnostic Laboratory.
Dr. Angela Lamerato-Kozicki of the University of Wisconsin-Madison received a Young Cancer Investigator's Award from the American Kennel Club Canine Health Foundation for her oral presentation “Canine hemangiosarcoma originates from hematopoietic precursors with potential for endothelial differentiation” at the recent Genes, Dogs & Cancer Conference in Chicago.
Dr. James H. Steele has received the 2006 Abraham Horwitz Award for Leadership in Inter-American Health from the Pan American Health and Education Foundation for contributions to veterinary public health. He is a professor emeritus at the University of Texas School of Public Health, former assistant surgeon general for veterinary affairs with the U.S. Public Health Service, and one of the organizers of the American College of Veterinary Preventive Medicine.
Proposals addressing dog overpopulation sought
The Morris Animal Foundation is announcing a special call for research proposals addressing dog overpopulation. The foundation has $165,000 to fund one- to two-year study focused on surgical and/or nonsurgical sterilization methods or programs advancing the health and welfare of individual and/or populations of dogs.
Full proposals are due Nov. 10, 2006. Full proposal guidelines are available at www.morrisanimalfoundation.org/apply/fullproposal.asp?section=2,0,1; enter “grants” in the Login section and the password is “science.”