WASHINGTON -- The Senate is expected to pass the FDA UserFee Act on Thursday before it adjourns, and President Bush isexpected to sign it. The Biotechnology Patent Protection Act,however, looks like it will have to wait until next year.
The FDA bill would hasten drug approval by assessingcompanies $100,000 for new drug applications. It would usethe money to hire more staff at the FDA. The fee would rise to$230,000 over five years, though companies with fewer than500 employees seeking their first application would pay halfthe going rate. The FDA would have the authority to reduce orwaive fees if these would "hinder innovation."
New drug approval time supposedly would be reduced by halfwithin five years, or for the life of the bill.
"The question of whether (the bill) will be renewed will turnsignificantly on what progress FDA has made," said LisaRaines, vice president for government relations at theIndustrial Biotechnology Association (IBA).
Sponsored by Sens. Edward Kennedy, D-Mass., and Orrin Hatch,R-Utah; and Reps. Henry Waxman, D-Calif., and John Dingle, D-Mich., the bill has been stalled twice. Hatch added anamendment that would have watered down food labelingrequirements, but he and Kennedy, who represented Democraticsupport of the requirements, worked out a compromise.
Sen. Howard Metzenbaum, D-Ohio, added an amendment to theOrphan Drug Act on Monday that would have reduced adeveloper's exclusive rights from seven years to however longit would take to sell $200 million worth of the product -- amove the IBA strongly opposed.
At the urging of members of the association, Hatch rejectedMetzenbaum's amendment. Then the House voted as it wasadjourning Tuesday to pass the bill with Kennedy's and Hatch'sproposed amendments, making it impossible for Metzenbaum'sproposal to become law this year.
Meantime, Rep. William Hughes, D-N.J., chairman of the HouseIntellectual Property Committee, blocked the BiotechnologyPatent Protection Act. The act would have closed a loophole inpatent law that has allowed foreign companies to export to theU.S. pharmaceuticals made with U.S.-patented genes or hostcells.
"The law would use what we call a belt-and-suspendersapproach," Raines said. "One provision would make it easier toget biotechnology process patents, which already have theseborder enforcement rights. The second provision would createborder enforcement rights for host cell patients."
Hughes, who said he is favorably disposed toward the bill,claimed to need time to study it. He said he will take thematter up next year -- to the dismay of Raines and the IBA.
"There have been three hearings over the last three years onthis issue," Raines said. "The Senate has acted, and we werehoping Congress would act before the Senate adjourns."
Because of Hughes' procrastination, she said, "it could taketwo more years to pass."
-- David C. Holtzman Special to BioWorld
(c) 1997 American Health Consultants. All rights reserved.