WASHINGTON _ Concerned that the planned GOP taxcut is far too big to be politically feasible, conservativesin the Senate are looking for ways to roll it back,including limiting the capital gains tax cut backed by theBiotechnology Industry Organization (BIO).

"The planned four-year limit articulated by the Senateconservatives would be a disincentive to investors whowant to hold onto their investments for more than fouryears," said Chuck Ludlam, BIO's vice president ofgovernment relations. "It's biased against long-terminvestment."

The Senate conservatives also are eyeing reducing thecost of the research and development and orphan drug taxcredits as well as many other provisions to scale back thesize of the tax cut package.

BIO is telling the Senate that any four-year sunset of thecapital gain tax cut "is completely incompatible" with theventure capital bill that would give special tax treatmentto new investments made in the stock of a small companyheld at least for five years.

The fate of the capital gains tax appears caught up inPresidential politics. When Senate Majority Leader BobDole (R-Kan.) earlier this week told reporters that that theSenate may not be able to pass as large a tax cut as theHouse, he immediately came under fire from conservativerival Sen. Phil Gramm (R-Tex.). House Speaker NewtGingrich (R-Ga.) also turned the heat up under Dole bychiding him not to back away from the party's promisedtax cut.

The Clinton administration has not said whether it willsupport a capital gains tax break but has criticized theGOP proposals for giving too many corporations toomany tax advantages at the expense of cutting Medicareand Medicaid.

Senate action on tax reduction begins this week in theSenate Finance Committee which includes both Dole andGramm as members. Committee Chairman William Roth(R-Del.) told the Associated Press this week that he has"serious reservations" about limiting the tax cut to fouryears but added that his committee will definitely belooking at reducing some corporate tax loopholes.

As The FDA Reform Saga Turns . . .

In other news on Capitol Hill, Sen. Nancy Kassebaum (R-Kan.), chairwoman of the Senate Labor and HumanResources Committee, is making "substantial changes" inher draft FDA reform plan, according to chief aide JaneWilliams.

Details on the revised Kassebaum set of principles areexpected to be announced this week. Kassebaum lastAugust unveiled a statement of principles that in manyways incorporated what BIO and the PharmaceuticalResearch and Manufacturers of America (PhRMA) hadincluded in their FDA reform plans.

Sources close to Kassebaum, who wished to remainanonymous, said they expected the revised Kassebaumbill to be stripped of its provision that would haveallowed FDA to delegate review of drugs to outside third-party reviewers. Kassebaum may be incorporatingchanges into her revised draft that would make theproposal more palatable to a number of conservatives onher committee, the sources say.

The Kassebaum principles that are expected to bemodified (See BioWorld Today, Aug. 8, 1995, p. 1)include the section that would have permitted the FDA torely more on institution review boards (IRB). Phase I andII clinical trials would not have needed FDA approval ifthey were not intended to support a product approvalapplication.

Also expected to be changed is Kassebaum's initialdecision to include a more restrictive provision onmarketing information than the one sought by BIO andPhRMA.

Kassebaum's first draft said that manufacturers would bepermitted to disseminate medical texts and compendiaarticles from peer reviewed scientific publications,presentations and proceedings of medical and scientificmeetings, disease management programs and protocolsand complete extracts of published extracts of suchmaterials. The manufacturers would have to include copyof the label or package insert and include a disclaimerthat some of the drug uses advocated had not beenapproved by the FDA. n

-- Michele L. Robinson Washington Editor

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