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Executive Summary

A one year extension -- to Dec. 31, 1991 -- of the 20% qualified research and experimentation tax credit for qualified research expenditures is included in the Omnibus Budget Reconciliation bill now awaiting the President's signature. The bill also extends the application of the statutory rule for the allocation and apportionment of R&E expenditures so that it applies to the first two taxable years beginning after Aug. 1, 1989, and on or before Aug. 1, 1991. Additionally, the 50% tax credit for clinical testing of drugs for rare diseases is extended through Dec. 31, 1991. Medicare coverage of erythropoietin is extended to self-administration under the bill, effective July 1, 1991. Beginning Jan. 1, 1991, payments for EPO will be revised so that they are based on 1,000-unit increments -- at a payment of up to $11 per 1,000 units. Rep. Dingell's (D-Mich.) FDA Emergency Enforcement bill, also known as the debarment bill, reportedly came close to enactment during the 101st Congress even though it never progressed beyond the hearing stage within the House Energy & Commerce Committee. Dingell plans to introduce his bill again in the next Congress. He will again focus on the generic drug industry before considering broader FDA enforcement reform legislation. Chart omitted.

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