SEATTLE -- Fresh from partial victories on bills before Congressin the past week, the Industrial Biotechnology Association wasin a mood to accentuate the positive at its annual committees'meetings here on Thursday.
"We are helping government learn that regulating a newtechnology doesn't have to mean limiting its growth ordiminishing its potential," Richard D. Godown, the IBA'spresident, told the opening public session.
Specifically, the U.S. Senate and House of Representatives haveeach passed a different IBA-backed bill, although neither billhas yet passed both chambers and reached President Bush.
The IBA remains hopeful about winning passage this month inCongress of what it considers the more important of the twobills to the biotechnology industry, the Dingell-Waxman bill. Itcalls for creating a system of FDA user fees to be charged tocompanies filing new drug applications, but with the proceedsused solely to improve the agency's drug-review process.
A second bill, passed last Friday by the Senate, but nowapparently stuck in a House subcommittee, would giveinventors a new legal avenue to challenge overseasmanufacturers of products that they believe infringe their U.S.patents covering certain biotechnology products. The Boucher-DeConicini patent-protection bill was authored with the IBA'shelp.
The top issue facing the industry next year is ensuring that theFDA fee system delivers on its promise of a faster-acting FDA,Godown said after the meeting. Noting the IBA's long-standingopposition to FDA user fees, Godown said this bill indeeddiffered from its predecessors, which were largely intended toraise federal revenues.
"Intensive effort by IBA and other trade associations changedthe landscape of this issue," he said. The new revenuesgenerated by the fees will be used to put up to 600 additionaldrug examiners on the FDA staff and help roll back anestimated 13-year backlog of drug applications awaiting theagency's review.
It is difficult to translate the added revenues generated by thefees into specific declines in the time needed to review drugapplications. However, the bill's backers anticipate that thecurrent average of 13 months for FDA review of a Class 1 drug-- one with significant therapeutic advantages over what's nowavailable -- could be cut to about six months, Godown said.Other drug applications could be reviewed in an average of 12months.
The bill passed the House last week with no significantopposition and went before a Senate committee hearing thisweek. It could still hit a snag due to concerns by a few Senatorsover FDA issues that are unrelated to user fees, according tothe FDA. As passed by the House, the bill provides a 50 percentreduction in the fees charged to small companies that have notyet received approval for a drug.
In a review of other federal issues, Godown noted the recentproposed streamlining of the approval process coveringproduction and transportation of genetically engineered plantfoods. Proposed by the U.S. Department of Agriculture's animaland plant health inspection service (APHIS), the plan wouldreplace a permit and 120-day review period that's nowrequired with a notification procedure for most biotechnologycrop plants.
The proposal "may have the most far-reaching impact on thegrowth on the biotechnology food industry of any event inmemory," Godown said.
Nearly as important was that the IBA finds itself teaming up atraditional foe, the Environmental Defense Fund, in lobbying forthe proposal before the Bush administration. "The IBA and EDFare strange bedfellows on this issue, but we'll both seebenefits," Godown said.
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.