Industry hopes fees jump start drug approval process

Washington-Awaiting congressional support, animal pharmaceutical manufacturers plan to speed up the drug approval process by investing millions into the U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) through self-imposed industry fees.

Dr. Bernadette Dunham

It's called the Animal Drug User Fee Act or more commonly, ADUFA, and it's expected to be introduced this month as Congress reconvened Jan. 7. While a similar measure has graced the human medical side for a decade, no other disbursement has ever supported federal veterinary drug regulators in this fashion.

Language in the bill calls for a $43 million drug industry payout to the CVM over five years. The funds presumably will beef up manpower and education for CVM scientists reviewing new products and most importantly, new chemical entities - drugs fundamentally different from those existing on the market. Congressional backlog stymied the legislation's passage last year, but proponents remain confident that the soon-to-be reintroduced work won't receive much resistance considering both sides of the issue are on board.

It's the industry's ticket to selling more drugs, says Ron Phillips spokesman for the Animal Health Institute (AHI), which represents pharmaceutical manufacturers. From fiscal year 1995 to 2001, the CVM approved just 35 new chemical entities (see Table 1), leaving drugmakers frustrated with the time-consuming process.

"The veterinary side in the last three to five years has been experiencing something similar to what the human side saw 10 years ago," he says. "Delays and significant backlog at CVM has virtually ground the approval process to a halt."

Major delays

In worst cases, Phillips says, pharmaceutical companies can wait more than 10 years to hear CVM review results.

"Frankly, drug companies are jaded," he says. "They spend a lot of money researching, creating products only to wait years before they'll even know if they can reap profits. It doesn't do well to stimulate research."

But even if the funding measure passes, veterinarians shouldn't expect to see an influx of pharmaceuticals pouring out of CVM, Phillips adds. "More importantly, what we want to see is predictability," he says.

What the money buys

The proposal ratchets down the average drug approval time at CVM from 300 days to 180 days for 90 percent of submissions within five years of the bill's enactment. FDA officials refused to comment on the bill's predicted influence at CVM, but Dr. Bernadette Dunham, acting director of the American Veterinary Medical Association's Governmental Relations Division, says funneling money into the government agency puts a much-needed spotlight on the review process.

"Drugmakers realize they can't have manufacturers present applications with state-of-the-art microbiology without funding education for the reviewers," says Dunham, who since speaking with DVM Newsmagazine accepted a post as deputy director of the CVM Office of New Animal Drug Evaluation. "On the other side, it should tighten the CVM process. With this kind of money, regulators know the pharmaceutical companies want to see change."

Trickling down to DVMs

In the end, the legislation should alleviate the logjam at CVM, which pharmaceutical manufacturers eagerly await. While officials with Pfizer Animal Health, a leader in animal health research, won't reveal the number or type of products currently in the CVM pipeline, Dr. Ann Jernigan, executive director of Veterinary Medicine and Pharmaceuticals Discovery, admits accelerated review times are necessary for the company's growth.

"We're really research-driven so timeliness is important," she says. "Veterinarians and producers are waiting for products on our lines. It's our end-users who matter."