User fees to hasten drug approvals for the veterinary market just became a reality.
Legislation became law after President Bush signed off on a new plan to infuse cash to speed veterinary drug approvals by
the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM).
The Animal Drug User Fee Act (ADUFA) garnered wide support from the Coalition for Animal Health, an industry lobby including
the American Veterinary Medical Association and the Animal Health Institute.
FDA Commissioner Mark B. McClellan, MD, Ph.D., said in a prepared statement, "We expect that the new resources that ADUFA
provides will greatly strengthen FDA's animal drug review capabilities, in much the same way that user fees improved our ability
to more quickly and efficiently review human drugs."
McClellan cited the need for the fees "because a prolonged decrease in resources in the 1990's resulted in a slower, less
predictable animal drug review process."
Dr. Stephen Sundlof, director of CVM, adds, "The passage of ADUFA marks the beginning of a new era in CVM history just as
the Prescription Drug User Fee Act beneficially altered the review of human drugs."
Dr. Stephen Sundlof
FDA explains that ADUFA establishes four fees: a sponsor fee, an establishment fee, a product fee and an application fee.
FDA expects to receive $5 million for fiscal year 2004, which began on Oct. 1. Each of the fee categories are expected to
generate 25 percent of the total revenue collected.
FDA adds that this new revenue will be directed exclusively toward CVM's animal drug review program.
"The goal is to achieve shorter, more predictable review times by increasing the review staff at CVM and building better management
systems," the agency reports.
Industry couldn't be more pleased.
The Coalition for Animal Health not only supported the legislation, but pushed for its passage.
In a statement issued by the Animal Health Institute, Mathews says, "This is a victory for pet owners, veterinarians, farmers,
ranchers and consumers."
FDA adds that just because larger companies pay more based on the number of products it has up for review, there are mechanisms
to make the system fair for smaller outfits.
The new law provides for specific waivers or reductions in fees for small businesses when these fees would present "a significant
barrier to innovation."
Government officials are preparing more detailed guidance and information for the animal health industry regarding the fees.
A work in progressThe fees will apply to applications submitted on or after Sept. 1. But, FDA explains, before the agency can begin to collect
fees, Congress needs to pass an appropriations act providing for the new animal health money.
In other words, it's business as usual for the FDA until detailed payment procedures and appropriations are enacted.
FDA must first publish an announcement in the Federal Register outlining specific procedures, before it can accept payment
for the user fees.
No dates for publication have yet been set.
For more information go to www.fda.gov/oc/adufa.