December 15, 2008

 

 Bridge funds coming to FARAD may not be enough - December 15, 2008

 

Closure could impact veterinary care, contamination response, and international trade

 

posted December 1, 2008
 
Dr. Lisa Sanford
Dr. Lisa Sanford, one of the owners of Sterner
Veterinary Clinic in Ionia, Mich., examines a culture
and sensitivity plate typical of those used in determining
whether extralabel drug use is warranted.
Dr. Keith Sterner, another owner, said having
FARAD as a resource for such therapy can help
ensure the proper route of administration, dosage,
and residue avoidance strategies are used.
 

"I think of (FARAD) as an unbiased source of information, and I don't have to feel like I'm putting a technical services veterinarian from a pharmaceutical company on the spot with regard to either minor species use or an extra label use that might get that tech services veterinarian or the company itself in difficulties with the Food and Drug Administration."

—DR. KEITH STERNER,
CO-OWNER, STERNER VETERINARY CLINIC,
IONIA, MICH.

Federal agencies are giving $125,000 in bridge funding to the Food Animal Residue Avoidance Databank, which has started layoffs to stay open.
 

The service is still far short of its approved funding level, and the new funds could still be too little to ensure FARAD survives.

The AVMA Executive Board also approved $5,000 in seed money for FARAD Nov. 14, provided other stakeholders also contribute (see page 1811).

Federal lawmakers authorized $2.5 million per year in the Farm Bill for FARAD, but the money has not been appropriated. Without more money, the service is expected to shut down by mid-2009.

Through a pair of letters to two U.S. congressmen, Agriculture Secretary Edward Schafer pledged $75,000 to the university-based FARAD consortium.

Schafer wrote to the congressmen, Leonard Boswell (D-3/Iowa) and Robin Hayes (R-8/NC), in response to a letter they sent to the U.S. Department of Agriculture July 10 that expressed concern over the lack of funding for FARAD. The congressmen are the chair and ranking member, respectively, of the House Committee on Agriculture Subcommittee on Livestock, Dairy, and Poultry.

Susan McAvoy, spokeswoman for Chairman Boswell, said the congressman hoped the USDA would provide hundreds of thousands of dollars in funding, and she described the $75,000 pledge as inadequate.

An FDA spokesperson said the agency had, in responding to a similar letter from two congressmen, drafted a letter promising $50,000 to FARAD. The letter had been sent to Health and Human Services Secretary Mike Leavitt for his signature, but it had not been signed by press time in November.

Dr. Alistair Webb, one of FARAD's three directors and a professor at the University of Florida-Gainesville, said the organization has cut staff so it can continue consulting duties on extralabel drug use.

"We're cannibalizing everything we can to keep the phones up," Dr. Webb said. "That's our priority."

One of the layoffs involved a woman who had entered data for 20 years, Dr. Webb said. If FARAD runs out of money and shuts down, it will take between one and two years to restart the program from scratch.

In the event the program closes, FARAD would lose specialized employees and programmers, the toll-free phone number, and Web site. Dr. Webb said the prospect of closure has been painful, but FARAD has worked in the public interest for 20 years.

"Everybody is trying to get money for FARAD—AVMA, USDA, FDA—all trying to find money to help us survive through either when the '09 budget gets approved and it has money in it or the Farm Bill authorization gets appropriated," Dr. Webb said.

Dr. Webb said FARAD has a program with a patented algorithm that provides estimated withdrawal times, but it still requires interaction from specialists. The people trained in pharmacology, toxicology, and internal medicine who are operating the program are able to spot the results of potentially dangerous user or computer errors, rather than passing the results along to practitioners in the field.

The programmer in charge of the program's upkeep was among those recently laid off.

The Food, Conservation, and Energy Act of 2008—also known as the Farm Bill—authorized five years of funding at $2.5 million annually. The money would go to operations at North Carolina State University, the University of California-Davis, and the University of Florida.

Dr. Webb said the current lack of consistent funding presents problems in recruiting and "loyalty can only go so far" in retaining current employees.

"If we had (been) assured (of) money coming in, we could hang on to the people we've got and recruit people to replace those who have left," Dr. Webb said.

Losing FARAD could hurt U.S. food producers' businesses in international trade. FARAD helps those producers make sure their products meet requirements of foreign governments.

"Just recently, there was a change in Japan that required a whole lot of new withdrawal times for drugs administered to pigs that were exported to Japan," Dr. Webb said.

Dr. Paul Sundberg, vice president of Science and Technology for the National Pork Board, said FARAD has been an important source of information on how long animals need to be held to meet other countries' maximum residue limits, or MRLs. The loss of FARAD would cost producers a credible, science-based source that helps meet market specifications.

"When we have different MRLs for different countries, we need to ensure that we have science-based information for producers to understand what they have to do to meet that market," Dr. Sundberg said. "So we would lose an important source of that information for some of our animal health products."

Foreign MRLs have become important for pork producers, since exports began increasing in the mid-1990s, Dr. Sundberg said. At least a quarter of production is sent to other countries, and Japan is the top export market for U.S. pork.

Food that violates residue requirements is not accepted into countries' markets, and the owners have to pay to have it shipped back or destroyed, Dr. Sundberg said.

Dr. Thomas Burkgren, executive director of the American Association of Swine Veterinarians, said he had heard FARAD would permanently disappear if no funding arrived in time.

"I think that's really the take-home message: This is the last hurrah for them, and if we lose them this time, then we have to assume this time, it's for good," Dr. Burkgren said.

With extralabel use of a drug—whether involving different species, route, or dose—a veterinarian is required to give clients a withdrawal time that has a scientific basis. FARAD has published withdrawal times on some uses, but most withdrawal times are obtained through calls to FARAD, Dr. Webb said.

Calculations change over time, and extralabel drug use would be more difficult without recommendations that are current, Dr. Webb said.

Dr. Gatz Riddell, executive vice president of the American Association of Bovine Practitioners, described FARAD as "an exceptionally valuable resource that is not duplicated anywhere else." The service is useful for drugs with established research on extralabel use and pharmaceuticals that are new to the market, he said.

Dr. Riddell said each call to FARAD potentially impacts numerous treatments by veterinarians. FARAD's prior research would remain useful if the service shut down, but practitioners would no longer benefit from updates related to new research.

Dr. Keith Sterner, one of 10 veterinarians at Sterner Veterinary Clinic, a mixed-animal practice in Ionia, Mich., said he appreciates being able to call FARAD for researched advice on dosage and withdrawal recommendations. He praised the organization as "an authoritative resource that every veterinarian should know about and feel free to use."

"I think of (FARAD) as an unbiased source of information, and I don't have to feel like I'm putting a technical services veterinarian from a pharmaceutical company on the spot with regard to either minor species use or an extralabel use that might get that tech services veterinarian or the company itself in difficulties with the Food and Drug Administration," Dr. Sterner said.

A veterinarian from Sterner Veterinary Clinic has, for example, called FARAD for advice on extralabel tilmicosin use after conventional therapy failed in mastitis cases.

"Whenever there's a question, particularly as it regards extralabel use or minor species use, they're particularly helpful at helping us with an idea of what are appropriate withdrawals or even appropriate dosages," Dr. Sterner said.

Dr. Burkgren said FARAD's service would be "very difficult to find anywhere else, if not impossible."

"Veterinarians are the main line of information for extralabel drug use because of the requirements of the regulation," Dr. Burkgren said. "Certainly, from the industry standpoint, you lose antibiotics or drugs that you can use for treatments."

FARAD officials also provide information on contaminants and advised the FDA on withdrawal times for the contaminant melamine, an industrial chemical that can be used to artificially boost protein test scores in animal feed and food for human consumption.

FARAD's consultations are not limited to drug use, as the organization has in the past advised state agencies on withdrawal times when toxins entered feed mills. The advice has ranged from holding animals for a number of months to slaughtering them without allowing the meat to enter the market.

FARAD directly impacts drug use, contaminants, and trade issues on a daily basis. Research staff continuously tries to develop better predictions related to drugs and contaminants.

Dr. Webb said he hopes people will support FARAD by lobbying their representatives in government. "If they have a congressman they know, they should go and tell them that FARAD is important."