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.
FROM OUR SPONSORS
JOIN THE DISCUSSION
Close [ x ] More from GovExec
 
 

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

  • Going Agile:Revolutionizing Federal Digital Services Delivery

    Here’s one indication that times have changed: Harriet Tubman is going to be the next face of the twenty dollar bill. Another sign of change? The way in which the federal government arrived at that decision.

    View
  • Cyber Risk Report: Cybercrime Trends from 2016

    In our first half 2016 cyber trends report, SurfWatch Labs threat intelligence analysts noted one key theme – the interconnected nature of cybercrime – and the second half of the year saw organizations continuing to struggle with that reality. The number of potential cyber threats, the pool of already compromised information, and the ease of finding increasingly sophisticated cybercriminal tools continued to snowball throughout the year.

    View
  • Featured Content from RSA Conference: Dissed by NIST

    Learn more about the latest draft of the U.S. National Institute of Standards and Technology guidance document on authentication and lifecycle management.

    View
  • GBC Issue Brief: The Future of 9-1-1

    A Look Into the Next Generation of Emergency Services

    View
  • GBC Survey Report: Securing the Perimeters

    A candid survey on cybersecurity in state and local governments

    View
  • The New IP: Moving Government Agencies Toward the Network of The Future

    Federal IT managers are looking to modernize legacy network infrastructures that are taxed by growing demands from mobile devices, video, vast amounts of data, and more. This issue brief discusses the federal government network landscape, as well as market, financial force drivers for network modernization.

    View
  • eBook: State & Local Cybersecurity

    CenturyLink is committed to helping state and local governments meet their cybersecurity challenges. Towards that end, CenturyLink commissioned a study from the Government Business Council that looked at the perceptions, attitudes and experiences of state and local leaders around the cybersecurity issue. The results were surprising in a number of ways. Learn more about their findings and the ways in which state and local governments can combat cybersecurity threats with this eBook.

    View

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