FDA, AHI advocate veterinary drug user fees

Following reports of a drug user fee agreement between the Food and Drug Administration (FDA) and regulated human drug manufacturers, the Animal Health Institute (AHI) and FDA have blueprinted a similar arrangement.

The user fee initiative for veterinary medicine is designed to address"the severe backlog and lengthy review process at CVM (FDA Center forVeterinary Medicine)," says Ron Phillips, vice president, legislativeand public affairs, AHI.

If passed, the package will allow for the creation of performance standardsand user fees for the first time in veterinary medicine. The fees wouldthereby enable the hiring of more staff at FDA to speed up the review process.

Timing crucial

Although human drugs have been subject to user fees for 10 years, theact that created those fee standards is due to expire in September.

"Part of the reason for the timing of this (animal-health agreement)is that the Prescription Drug User Fee Act (PDUFA), the statute that establishesfees for human drugs, is being reauthorized this year. It seems to us tobe a natural that while Congress is doing that they would add in the animalside," Phillips says.

"CVM believes there is a need for more resources. The performancestandards then would impose discipline and impose deadlines on the reviewprocess and hopefully would lead to a more predictable, efficient reviewof applications," he adds.

Mirror image

The fee system for veterinary drug approvals, according to Phillips,would be "closely modeled" on the human drug-driven PDUFA, inwhich drug manufacturers pay for user fees. For each of the next five yearsthe act establishes specific targets for various types of reviews in exchangefor a fee structure that begins at $5 million in the first year, jumps to$8 million in the second year and levels off at $10 million for the third,fourth and fifth year, he explains.

Performance standards more or less measure how many days the FDA hasto review a particular type of application, says Phillips. There is an overall180-day limit in the statute, yet CVM's published figures reveal that certainreviews have exceeded as many as 300 days.

"Basically what you see in the performance standard side of (ouragreement) is a gradual ratcheting down to meeting the 180-day limit for90 percent of the applications in the fifth year," says Phillips.

The agreements for human and veterinary medicine will be presented toCongress, and AHI's Phillips says ideally they'd like to see a decisionmade by the end of this year.

Although the FDA declined to discuss details of the AHI partnership,Linda Grassie, spokeswoman for FDA Center for Veterinary Medicine, confirmedthat discussion about user fees is under way, adding "we're not readyto talk about any specifics."

She says thus far the agreement appears "more promising" thanprevious talks. M