WASHINGTON H The Bush administration is continuing toponder whether to make federally supported biotechnologyresearch a Presidential Initiative in the fiscal year 1993budget, which President Bush will present to the Congress onFeb. 4.

If approved, an initiative would commit the federalgovernment to increased funding and better coordination ofbiotechnology research activities in the fiscal year that beginsnext October.

The White House Office of Management and Budget (OMB) is inthe midst of final budget negotiations with the departments,said Donald Poppke, chief of the public health branch of theDepartment of Health and Human Service's office of budget.

The decision on a biotech initiative must be made and thebudget completed no later than Jan. 28, Poppke told BioWorld.

Government agencies with programs that would be part of theinitiative have been expecting a decision substantially ahead ofthis deadline, said an agency official close to the process whorequested anonymity.

OMB and the biotechnology research subcommittee of theFederal Coordinating Council on Science, Engineering andTechnology (FCCSET), which is part of the White House Office ofScience and Technology Policy, are reviewing the amountbudgeted for biotechnology research across all federal agencies,a process called the "biotechnology research crosscut."

OMB, with advice from the FCCSET, will decide whether torecommend an initiative based in part on whether thebudgeting represents a significant increase in funding forbiotechnology, according to the agency official.

Meanwhile, Congress also will enter the new year with anunfinished slate of biotechnology-related business, rangingfrom orphan drug law modifications to investment-oriented taxlaw changes.

The following summarizes the status of biotech-relatedlegislation.


Bill: Animal Research Facilities Protection Act

Senate: S. 544, Heflin, D-Ala.

House: H.R. 2407, Stenholm, D-Texas

Description: Makes it a federal crime to break into or vandalizeany animal research facility.

Status: House Agriculture Committee expects to consider billearly in 1992.


Bill: Human Genome Privacy Act

Senate: No legislation

House: H.R. 2045, Conyers, D-Mich.

Description: Prevents federal agencies from releasing geneticinformation on individuals without their consent.

Status: Hearings by the House Committee on GovernmentOperations about possible uses and misuses of geneticinformation were held in October.


Bill: Enterprise Capital Formation Act

Senate: S. 1932, Bumpers, D-Ariz.

House: H.R. 3741, Matsui, D-Calif.

Description: Provides capital gains tax differential forindividual and corporate taxpayers who invest in start-up andother small companies. Exempts from capital gains tax half ofthe capital gains earned by investors who put up the first $5million in "seed" capital for young companies, provided theyhold onto their investments for five years. Investments heldlonger than five years would be eligible for an additional 10percent yearly exemption so that after 10 years they would betotally tax-exempt.

Status: Provisions similar to the Senate bill were included inlegislation (S. 2061) introduced Nov. 26 by Jim Sasser, D-Tenn.,which would amend the IRS code of 1986 to provide middle-income tax relief. The bill has been referred to the FinanceCommittee. House Republicans included a version of H.R. 3741in an economic growth package endorsed by President BushNov. 26.


Bill: Orphan Drug Amendments Act

Senate: S. 2060, Kassebaum, R-Kan.

House: H.R. 3930, Studds, D-Mass.

Description: Amends the Orphan Drug Law to eliminate marketexclusivity for a drug when the cumulative sales reach aspecified ceiling. The Senate bill would limit sales to $200million, while the House bill sets $150 million as a cap. Highdevelopment costs may allow a higher ceiling on particulardrugs.

Status: S. 2060 has been referred to the Labor and HumanResources Committee, with hearings likely in late January orFebruary. H.R. 3939 has been referred to the Energy andCommerce Committee.

Bill: Internal Revenue Code of 1986, Amendment

Senate: no legislation

House: H.R. 1713, H.R. 3551, Stark, D-Calif.

Description: Imposes a windfall profits tax on "excessivelyprofitable" orphan drugs.

Status: H.R. 1713 and H.R. 3551 have been referred to the Waysand Means Committee.


Bill: Biotechnology Patent Protection Act ("Boucher Bill")

Senate: S. 654, DeConcini, D-Ariz.

House: H.R. 1417, Boucher, D-Va.

Description: Expands U.S. patent law to cover the processesused to make products containing patented components.Amends present law to clarify the definition "obvious" used bythe Patent and Trademark Office. Under both bills, if apatentable material is included in a process claim and a patentis granted for the material, the process for making the materialwould be considered "non-obvious" and thus subject to patentprotection.

Status: Senate Judiciary Committee unanimously approvedSenate bill Nov. 21. Boucher's bill currently is in the HouseJudiciary Committee.


Bill: Federal-State Pesticide Regulation Partnership Act

Senate: S. 2085, Pryor, D-Ark.

House: H.R. 3850, Hatcher, D-Ga.

Description: Amends U.S. pesticide law to prohibit localregulation of pesticides.

Status: Introduced just before congressional recess inNovember, awaits Agriculture Committee action in both houses.

Bill: Circle of Poison Prevention Act

Senate: S. 898, Leahy, D-Vt.

House: H.R. 2083, Synar, D-Okla.

Description: Requires new pesticides to be approved for use inthe United States before they could be sold in other countries.

Status: S. 898 is in Agriculture, Nutrition and ForestryCommittee.


Bill: Product Liability Fairness Act

Senate: S. 640, Kasten, R-Wis.

House: H.R. 3030, Rowland, D-Ga.

Description: Reforms current product liability laws byestablishing a uniform product liability law to supercede statelaws.

Status: Reported by Senate Commerce Committee in November.The proposal may be before the full Senate in early 1992.


Bill: Internal Revenue Code of 1986, Amendment

Senate: S. 2042, Bentsen, D-Texas

House: H.R. 3903, Rostenkowski, D-Ill.

Description: Extends tax credits, including the R&D tax creditand orphan drug tax credit, until June 30, 1992.

Status: President Bush signed the bill into law on Dec. 11.

Bill: Internal Revenue Code of 1986, Amendment

Senate: S. 416, Danforth, R-Mo.

House: H.R. 1618, Jenkins, D-Ga.

Description: Makes the research and development tax creditpermanent.

Status: The Senate bill was added to Sasser's economic growthlegislation introduced Nov. 26 (S. 2061).

-- Kris Herbst BioWorld Washington Bureau

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