House panel backs user fees for FDA animal drug reviews

The House Energy and Commerce Committee Wednesday approved legislation that would authorize a user-fee program for Food and Drug Administration reviews of animal medications.

The Animal Drug User Fee Act (H.R. 1260), which passed by voice vote, without amendment, is similar to the Prescription Drug User Fee Act that was enacted in 1992. In this case, applications for FDA review of new animal drugs would have to be accompanied by payment of a substantial fee to help pay for and expedite the review process. The bill sets the user fee for an application at $1.25 million for fiscal year 2004, $2 million for fiscal 2005, and $2.5 million for fiscal 2006, 2007, and 2008.

The bipartisan bill received no significant criticism from Democrats, although Rep. Henry Waxman, D-Calif., asserted that user fees alone are not sufficient to support the FDA review process, which he said "has been underfunded for several years." Congress must appropriate the full amount needed to supplement the money generated by the fees, Waxman said.

Committee Chairman W.J. "Billy" Tauzin, R-La., informed Waxman that he had spoken to House Speaker Dennis Hastert, R-Ill., and assured Waxman that he had "the Speaker's word" that appropriators would be able to make up the difference needed to cover the costs of the review process.

Stay up-to-date with federal news alerts and analysis — Sign up for GovExec's email newsletters.
Close [ x ] More from GovExec

Thank you for subscribing to newsletters from
We think these reports might interest you:

  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

  • The Big Data Campaign Trail

    With everyone so focused on security following recent breaches at federal, state and local government and education institutions, there has been little emphasis on the need for better operations. This report breaks down some of the biggest operational challenges in IT management and provides insight into how agencies and leaders can successfully solve some of the biggest lingering government IT issues.

  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.

  • Ongoing Efforts in Veterans Health Care Modernization

    This report discusses the current state of veterans health care


When you download a report, your information may be shared with the underwriters of that document.