FDA receives some criticism on new animal drug approval procedures

Comments have started to come in on a request from the U.S. Food and Drug Administration (FDA) for ways to address unapproved animal drugs.

The FDA published a notice in the Federal Register, saying it wants to find ways in which it can make more drugs available legally to veterinarians and pet owners.

According to the notice, the agency is willing to consider avenues not only within its existing regulatory framework, but also new ideas on how to make certain drugs legally available. The FDA will also look at using "enforcement discretion," in other words, they will not shut down a company for selling an unapproved drug if that drug is essential to an animals health.

So far the comments received have been limited. Two organizations, the American Veterinary Medical Association (AVMA) and the Animal Health Institute have requested an additional sixty days to consider the FDAs request.

An FDA Center for Veterinary Medicine (CVM) spokeswoman said the FDA does not have a backlog on new animal drug applications, so that is not the reason for the agencys request. Two laws, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), established a framework by which drug manufacturers contribute funds to supplement appropriations for drug review, according to the FDA.

"The funding is tied to CVM meeting specific performance goals that ensure timely and efficient scientific evaluation of the safety and effectiveness of new animal drugs, said Laura Alvey,
deputy director of communications for the CVM. "Under these programs, any backlog of submissions was eliminated and CVM consistently meets or exceeds the performance goals, including the timely review of new animal drug applications."

In the four year period of 2006-2009, the CVM approved about 120 new animal drug applications, Alvey said. The 2010 report will show about 20 more approvals for the past year, she said.

Alvey said the purpose of the FDAs request is to look for alternative approaches to the new animal drug approval process, not to revise the process.

However, two veterinarians who weighed in on the issue thought the process might need revision.

"Here is the reason that many medical drugs that veterinarians use are ‘off label,’" wrote Sharon Sprouse, DVM, owner of Penasquitos Pet Clinic in San Diego, Calif. "The companies that manufacturer such medications often do so for human use. These companies, according to FDA rules, have to do research on their products for each species on which it might be used. This is very expensive. Many of these companies consider Veterinary Medicine a "vertical market" which to the companies means they wont recoup all the money they spend researching their product for each species of animal it is to be used on. So they dont do the research needed."

George Danner, DVM, of the Maine Conservation Medicine Center, said that he developed a fish anesthetic from several ingredients that are used as flavorings in human foods and are generally recognized as safe (GRAS). However, Danner said he will be required to perform toxicity testing on the anesthetic.

"Please create consistency in the manner in which GRAS substances can be utilized," Danner wrote. "It is not right that they can be used without disclosure as a flavoring substance, but not used at all as active ingredients without millions of dollars in toxicity testing. If a GRAS substance can be used as a flavoring ingredient at a given PPM in a pharmaceutical preparation then it should also be able to be used as the active ingredient up to that same PPM. That would provide logic and consistency in the FDA regulation."

To leave a comment on the FDAs notice, visit http://www.regulations.gov and search for Docket No. FDA-2010-N-0528.

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