WASHINGTON _ When the Republican-controlledCongress came to power in January, its leaders promisedfundamental changes in spending priorities and relief forbusiness. But much of the legislation to affect thosechanges is bogged down in partisan politics.

With the White House and congressional Republicansunable to agree on which domestic programs to cut, astalemate has ensued since they returned in earlySeptember, pushing other legislation out of the way whilethis debate occupies Congress' center stage. FDA reformlegislation, tax cuts, and patent law changes probably willnot be addressed until next year.

What follows is an overview of these bills and their likelyfate in the next few months of this congressional session:

* FDA Reform. While the Clinton Administrationpreviously maintained that FDA reform could beaccomplished administratively, its position appears to besoftening a bit. FDA Associate Commissioner for PolicyBill Schultz told BioWorld Today that the administrationwill accept legislation to reform FDA.

While a consensus exists in Congress that the FDA needssome repairs, particularly in the way it regulates medicaldevices, the House Commerce and Senate Labor andHuman Resources Committees have been too busyfiguring out how to cut over $250 billion from Medicarespending to think about FDA reform. If congressionalRepublicans and President Clinton agree to put thegovernment on a continuing resolution, which permits allfederal agencies to continue operating past the end of thefiscal year on Sept. 30, 1995, there may be an opportunityfor action on other legislation, said several drug industrylobbyists. However, if they remain deadlocked on thebudget, a window of opportunity to take up FDA reformwon't be opened.

Once Congress focuses on the FDA, Stephen Conafay,executive vice president of the Pharmaceutical ResearchManufacturers of America, said the most contentiousissues will be whether manufacturers will be able tosubmit a summary of clinical trial data, how theydisseminate information about their products, andexpedited review of certain life-saving drugs. Conafaypredicted that "there will be a big fight in committee witha high level of debate."

Conafay said the Clinton administration will talkcompromise with the drug industry as well as Congressbecause of political pressure. "The gay community isexerting pressure on Clinton to expand accelerated drugapprovals which would require legislative notadministrative action," Conafay told BioWorld Today.

Conafay said he has been "holding discussions at alllevels of the administration, including the FDA andWhite House, to discuss areas of common interest."

So far, only one proposal for FDA reform has beenintroduced by a member who serves on a committee withjurisdiction over FDA enabling legislation. Rep. RonWyden (R-Ore.) several months ago threw his FDAreform bill (HR 1742) into the Congressional hopper.How active Wyden will be on FDA reform now that hehas formally declared for the Senate seat held by retiringSen. Robert Packwood (R-Ore.) remains to be seen.

Sen. Nancy Kassebaum (R-Kan.), who chairs the SenateLabor and Human Resources Committee, in Augustcirculated her principles for FDA reform and is expectedto introduced her legislative proposal within 30 days,according to Carl Feldbaum, president of theBiotechnology Industry Organization (BIO).

Rep. Thomas Bliley (R-Va.), chairman of the HouseCommerce Committee, appears ready to act on FDAreform after the budget stalemate is broken. Bliley alsointends to leapfrog over House Commerce HealthSubcommittee Chairman Michael Bilarakis (R-Fla.), arare procedural short-circuit, and begin action on FDAreform bills in the full committee, said Feldbaum at apress conference on Tuesday.

Interest in FDA reform continues to percolate in theHouse Government Reform and Oversight Committeewhich has held two hearings on FDA regulation, bothfocusing on medical devices. Rep. Jon Fox (R-Pa.),whose district includes a corridor of medical device anddrug manufacturers, has introduced his version of FDAreform (HR 1995) as well as a separate bill (HR 2290)streamlining FDA review of medical devices. The Foxbill includes a provision that would reclassify in vitrodiagnostics, including those with a biotech feature, fromClass III requiring premarket notification to the lessrigorous 510(K) review process, said Bruce Carroll,director of government relations for Centocor, Inc.,Malvern, Pa.

"Right now the costs associated with pushing theseproducts through Class III are prohibitive," Carroll toldBioWorld Today.

* Tax Breaks. The research and development tax creditextension, so sought after by biotech and other drugmakers, appears to be slipping away. Already anotherindustry is lobbying the House Ways & MeansCommittee to rewrite the terms of the tax credit to benefitdefense contractors at the expense of biotech firms. (SeeBioWorld Today, Sept. 12, 1995, p. 1.)

BIO is lobbying to restore provisions favorable to biotechfirms but the larger budget debate may decide how manydollars are available for any tax credits, including capitalgains and orphan drug tax credits.

* Patents. The biotech industry continues to work behindthe scenes with the American Medical Association andother physician groups that are strongly backinglegislation that prohibit patents for medical procedures.The Ganske-Wyden patent bill (HR 1127), named for co-sponsors Reps. Greg Ganske (R-Iowa) and Ron Wyden,will be considered in detail at hearings next month.

Two bills governing patent terms granted by the U.S.Patent and Trademark Office have also split the biotechindustry. Reps. Dana Rohrbacher (D-Calif.) and CarlosMoorhead (R-Calif.) have conflicting versions of patentterm legislation. How much support either has on theHouse Judiciary Committee will become clearer at a Nov.1, 1995, hearing when other members have a chance toair their views.

Many biotech firms are working with the IntellectualProperty Organization (IPO), an umbrella group of over90 research intensive companies to support the Moorheadbill. IPO executive director Herb Wamsley told BioWorldToday that his organization is backing the Moorhead billdespite the fact that at the beginning of the August recessRohrbacher had over 192 co-sponsors. Wamsley said"once biotech makers become better informed they willsupport Moorhead's bill because it maintains their 20-year patent term protections."

* NIH Funding. The National Institutes of Health (NIH)was given a soft landing compared to other federalagencies when Congress made cuts in domestic spending.Thanks to stalwart backers in the Senate AppropriationsCommittee and House Labor-Health and Human Services(HHS) Appropriations Subcommittee Chairman JohnPorter (R-PA.), NIH escaped with a comparativelygenerous 5.7 percent budget increase when the Housepassed its budget bill in early August. The Senate has yetto take up the Labor-HHS funding bill. n

-- Michele L. Robinson Washington Editor

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