Congress clears FDA user fees to rally drug approvals

Washington-The U.S. House of Representatives OK'd legislation that would give the Food and Drug Administration (FDA) an infusion of new monies to spur approvals of new animal drugs.

A similar version of the Animal Drug User Fee Act (H.R. 1260) passed the Senate. The next Congressional move will be to consolidate the language of the bills and send it to President Bush for approval. H.R. 1260 was sponsored by Fred Upton (R-MI).

What it means

Ron Phillips, vice president of legislative affairs for the Animal Health Institute (AHI), says that he does not expect any opposition to passage. The legislation has broad support from FDA, AHI as well as the Coalition for Animal Health, which includes the American Veterinary Medical Association (AVMA).

Dr. Lyle Vogel, director of scientific activities for AVMA, says passage of the legislation ranks as one of the most important legislative priorities for the association.

Dr. Lyle Vogel

Vogel says, "We were very supportive of this legislation. We feel it will decrease FDA review time, thereby releasing better and more drugs to the market."

Cash infusion

Phillips adds that the FDA's Center for Veterinary Medicine spends about $22 million a year on approving new animal drugs. The legislation will up the ante to approve new animal drugs: $5 million this fiscal year (2004), $8 million next year and $10 million a year for 2006, 2007 and 2008.

Alexander S. Mathews, president and CEO of AHI, says, "Congressman Upton deserves a great deal of credit for shepherding this important bill through the House. This bill will help ensure a steady supply of new and innovative products used by veterinarians, pet owners, and farmers and ranchers to maintain healthy animals.

Alexander S. Mathews

"This bill fixes a broken review process at FDA and will help ensure significant research and development efforts are continued," Mathews says.

Phillips explains that the legislation is closely modeled after the Prescription Drug Users Fees Act (PDUFA) in human medicine. The success of this model during the last decade was enough to get the nod from all the major stakeholders.

Phillips says, "This bill is modeled very precisely with what they have with PDUFA, and it is pretty straightforward. We are going to pay fees in exchange for CVM being held to performance standards and time limitations."

In addition to approving drugs in a timely fashion, the legislation adds predictability to the system, Phillips says.

Manufacturers want to know that if they research and develop compounds, FDA will follow-up with timely reviews, he explains. AHI says the legislation will help speed approvals, which in turn will help companies continue efforts to research and develop new medical compounds.

"It has worked for human drugs, and we have reason to believe that it can work for animal drugs. There are checks and balances written into the legislation as well as human drugs in case it doesn't work. We are confident it will work," Phillips adds.

User fee collection is designed so that the fee burden on a particular company will be roughly commensurate with the amount of activity a company has before CVM.

"Companies with a lot of registered products and a lot of products up for review are going to pay more than companies with just a few," Phillips says.

Once passed, the new legislation will take effect with the 2004 fiscal year, which began in early October.