Proposed FDA drug application fees top a busy agenda ofbiotechnology-related issues before Congress this week.

The FDA fee package, which is expected to collect $330 millionover five years for improvements to the agency's drug-reviewprocess, could clear the Congress "as early as Thursday orFriday," said Lisa Raines, vice president of governmental affairsfor the Industrial Biotechnology Association (IBA) ofWashington, D.C., which helped draft the bill.

With broad industry backing and little apparent opposition, thebill has been moving through Congress at the speed of a freighttrain. Still, Raines cautioned, it could be sidetracked in theSenate. One potential derailer: a possible amendment from Sen.Orrin Hatch, R-Utah, to extend regulatory relief to vitaminmakers. That, or a similar action, could throw the issue over toa new Congress next January.

The House of Representatives is expected to vote on FDA feeseither today or Tuesday, Raines said. A hearing on the bill isscheduled for Tuesday before the Senate Labor and HumanResources Committee. Mark Skaletsky, chairman of EnzytechInc., is scheduled to testify on behalf of the IBA. The full Senatecould vote on the issue this week, and the Bush Administrationis believed to support the bill, Raines said.

The bill proposes a new fee for filing a new drug application(NDA), which would start at $100,000 in fiscal 1993 that startsOct. 1 and climb to $233,000 by 1997. It would apply to drugs,vaccines and biologics.

Other new fees would charge drug makers an annual productlicensing fee for each prescription drug (starting at $6,000 andrising to $14,000 by 1997), a one-time establishment fee(escalating from $60,000 to $138,000 in the same period), anda $100,000 fee on filings for over-the-counter versions ofprescription drugs.

The Association of Biotechnology Companies (ABC), whichsupports the bill, is seeking amendments to extend a one-yearexemption from all fees for companies with fewer than 500employees filing their first NDA, or for products designated bythe FDA as an orphan drug. The bill now proposes a 50 percentfee cut for such small companies filing their first NDA.

Other biotechnology-related issues on the legislative calendarinclude:

-- A possible Senate vote this week on the BiotechnologyPatent Protection Bill. The so-called "Boucher bill" is intendedto give U.S. patent holders another tool to fend off imports offoreign-made goods found to infringe their patent. The billwould allow patent holders to petition the federal InternationalTrade Commission (ITC) to order an embargo on imports foundto conflict with a patent covering a genetically engineeredorganism. The Senate could vote on the bill next week, Rainessaid. A House version of the bill has yet to be voted out of theHouse Intellectual Property subcommittee.

-- A hearing Wednesday before the Senate patentsubcommittee considering the patenting of genes andgenetically engineered organisms. Scheduled to appear are Sen.Mark Hatfield, R.-Ore., David Beier, a lobbyist for GenentechInc., and a representative for the Jeremy Rifkin's Foundation onEconomic Trends. Hatfield earlier this year withdrew anamendment that proposed a three-year moratorium on theissuance of U.S. patents covering human genes and geneticallyengineered organisms.

-- A Sept. 29 Senate subcommittee hearing on the HumanTissue Transplant Act (Senate Bill 2908) that proposes federalstandards for the FDA to regulate all types of tissuetransplants, including blood, organs and cells, similarly todevices.

One issue that's not expected to appear in the waning days ofthe 102nd Congress are amendments to the Orphan Drug Act.Proposals to trim the benefits extended to orphan drugdevelopers once a designated product tops $200 million in salesappear to be dead for this session, said William E. Small, theABC's executive director.

The ABC has supported a proposal to strip the seven-yearmarket exclusivity from such orphan-designated drugs. Smallmaintains that charging high prices for orphan-designateddrugs "is setting us up for a big fall next year," when theCongress is likely to grapple with proposals for controllingescalating medical costs. "The fact is it does look bad. "

-- Ray Potter Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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