WASHINGTON -- The Industrial Biotechnology Association willlend qualified support for Food and Drug Administrationregistration fees in congressional testimony scheduled fortoday.
Several members of Congress, including Rep. John Dingell, D-Mich., and Sen. Orin Hatch, R-Utah, are discussing theimposition of an annual registration fee of $1,000 to $5,000 onall entities subject to FDA regulation.
The Bush administration's $770 million request for FDAappropriations includes $197 million in user fees.
"IBA believes that the facilities registration fee proposaldiscussed by (Energy and Commerce Committee) ChairmanDingell addresses several of our objections to theadministration's user fee proposal," IBA President RichardGodown said in testimony prepared for the rural development,agriculture and related agencies subcommittee of the HouseCommittee on Appropriations. "While not an endorsement of anFDA facilities registration fee, IBA does believe that this type ofproposal ... would not unduly burden the U.S. biotechnologyindustry," Godown said in the testimony, which BioWorldobtained on Wednesday.
IBA would support a registration fee only if the funds wereused to supplement existing FDA resources. Unlike theadministration plan, funds raised under the Dingell proposalwould not be used to supplant existing appropriations.
Bruce Merchant, vice president at Viagene Inc., today willregister the Association of Biotechnology Companies' objectionto the registration fee or any other user fee.
"Small companies that are the source of a disproportionatelylarge fraction of new innovations but are financially fragile feelthat they could be driven out of business or disproportionatelyimpacted by the fees," according to Merchant's testimonyobtained by BioWorld. While a $1,000 to $5,000 annual feewould not be burdensome, it could be a prelude to much largerfees in the future, ABC Executive Director Pamela Bridgen toldBioWorld. -- Steve Usdin
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