WASHINGTON _ With fewer than 30 legislative work days leftbefore Congress adjourns for the fall election campaigns, many of thelegislative proposals backed by the biotechnology industry may fallvictim to a crowded legislative calendar or the vicissitudes ofpresidential politics.

The collapse earlier this year of the deficit reduction plan sought byCongressional Republicans has opened the way for debate on anumber of proposals identified as priorities by the BiotechnologyIndustry Organization (BIO) and several of its members. But thatopportunity has been mitigated by the looming presidential andcongressional election politics which are coloring many decisions. Inaddition, Congress adjourns in mid-July for the four-month fallcampaign recess, sharply reducing the time to act on these measures.

Following is an overview of the these legislative proposals and theirchances of enactment:

* FDA reform legislation, declared dead earlier this year by manyWashington observers, now has at best a slim chance of beingenacted this year. But those odds will be enhanced only if a numberof variables are eliminated. The Senate version, reported out of theSenate Labor and Human Resources Committee last month (seeBioWorld Today, April 1, 1996, p. 1), has not been scheduled forSenate floor action because several political compromises have yet tobe reached. In addition, Senate Majority Leader Robert Dole (R-Kan.) has not given any firm assurances that the bill will be broughtto the Senate floor for a vote.

Biotech industry lobbyists admit there are significant hurdles toovercome for FDA reform legislation to be enacted but they remainoptimistic. "There are still issues to be resolved. Clearly, if theSenators resolve these issues and decide to go forward then the billwill reach the floor," said Walter Moore, senior director ofgovernment affairs for Genentech Inc., of South San Francisco.

* Of vital interest to biotech firms that need the capital gains tax as ameans to facilitate financing of their expanding operations, a capitalgains tax cut currently lacks a legislative vehicle. The failed budgetreconciliation legislation had left room for $245 billion in tax rollbacks. (See BioWorld Today, Dec. 22, 1995, p. 1.) But now the taxcut package needs a suitable legislative vehicle to move it forward."No decisions have been made on to which bill a tax package couldbe attached," said Chuck Ludlam, BIO's vice president ofgovernment relations.

Ludlam said he anticipates a much smaller package of tax cuts _ only$130 million _ will move forward on Capitol Hill. The $130 billiontax package would include special tax considerations important tobiotech manufacturers, including extensions of the orphan drug taxcredit and research and development tax credit, Ludlam said. Theorphan tax credit gives manufacturers a credit for the developmentand manufacture of therapies given orphan drug status by the FDA.For every dollar spent on developing an orphan drug, a manufacturercould claim a 50 cent tax credit. Pending proposals would makepermanent the current research and development tax credit. "If thebroader tax package appears to be doomed, we would support anextension of these two tax credits," Ludlam said.

* The focus of the debate on how to improve patent protection forbiotech products will temporarily shift to the U.S. Patent andTrademark Office (PTO) which will hold hearings April 16, 23,1996, on search and examination procedures for patent applicationsfor DNA sequences. Next month, the PTO will focus on whethermedical procedures can be patented. Biotech companies areconcerned that the definition of medical procedure could be widelydrawn to incorporate many novel therapies. (See BioWorld Today,Feb. 29, 1996, p. 2.) Action to protect patent terms under the GeneralAgreement on Tariffs and Trade (GATT) treaty may be scheduled forlater this spring, Ludlam said.

* Health care reform, which loomed so large on the Washingtonlandscape in 1994, has reappeared but in a vastly smaller package.But even this narrowly drawn measure has enflamed consideredopposition from powerful health care lobbies including the HealthInsurance Association of America (HIAA), responsible for the Harryand Louise commercials that helped doom the ClintonAdministration's health care reform proposal. HIAA currently isconcerned about provisions in S. 1028, co-sponsored by Sens. NancyKassebaum (R-Kan.) and Edward Kennedy (D-Mass.) that wouldallow people with pre-existing conditions who change or lose theirjobs to keep their insurance coverage.

Currently lacked from the pending version of the bill is anamendment sought by Cambridge, Mass.-based Genzyme Corp. toremove lifetime caps from most health insurance coverage, enablinginsurers to cover the cost of expensive biotech therapies. (SeeBioWorld Today, Dec. 10, 1995, p. 1.)

That amendment, to be offered by Sen. Jim Jeffords (R-Vt.), isexpected to be voted on when the bill reaches the Senate floor.

* Legislation that would have limited the ability of individuals to suemanufacturers over product liability has dropped from being a highpriority for the drug industry. (See BioWorld Today, Aug. 7, 1995, p.1.) Sponsors of the legislation, in order to enhance its politicalacceptance, were forced to drop language called the "FDA defense"during House-Senate conference committee negotiations. Thislanguage would have shielded medical product manufacturers frompunitive damages if their products had been cleared by the FDA andno damaging information had been withheld from the agency. Thecurrent product liability bill is expected to be vetoed by PresidentClinton, setting the stage for a veto override attempt in the Senate. n

-- Michele L. Robinson Washington Editor

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