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PATENTS EXTENSION BILL FOR OLESTRA, ANSAID LOSES 11th HOUR BID, JOINING BIOTECH PATENTS, ORPHAN AMENDMENTS ON NEXT YEAR’s CARRYOVER CONGRESSIONAL AGENDA

Executive Summary

A revised patent extension bill encompassing Upjohn's nonsteroidal anti-inflammatory drug Ansaid, U.S. Bioscience's chemoprotective agent Ethyol and Procter & Gamble's fat substitute Olestra cleared the Senate Oct. 8 but failed to win House approval before Congress adjourned for the year. On Oct. 5, Sen. Glenn (D-Ohio), the original sponsor of S 1506 to provide the Olestra patent extension for home-state firm P&G, worked out an agreement with Senate Judiciary/Antitrust Subcommittee Chairman Metzenbaum (D-Ohio). The revised S 1506 was expanded to include the two other products and a modified version of House-passed legislation to establish new standards for future review of patent extension requests. The legislation would have extended the Ansaid patent for two years to 1995, the Ethyol patent three years, and the Olestra patent until 1997. While the House did not officially adjourn until Oct. 9, it took no substantive action after the morning of Oct. 6. The House stayed in session in case it was called on to provide final approval via unanimous consent votes to measures that had gained House-Senate agreement. However, House members believed that the differences between the House and Senate patent bills argued against unanimous consent approval, House Judiciary Committee staff said. The key difference between the House and Senate patent bills was the House's inclusion of an extension for Wyeth-Ayerst's NSAID Lodine while also excluding USB's Ethyol ("The Pink Sheet" Aug. 17, p. 10). The most significant pharmaceutical-related achievement in the 1993 session was the enactment of FDA user fees, both for the bill's impact on company outlays, FDA finances and future application review times and for the amount of cooperative effort on the bill by the Administration, Congress and industry (see related story, p. 3). Other bills enacted include a revision of the Medicaid rebate program (see related story, p. 6) and an FDA debarment law directed at individuals and firms involved in generic drug fraud ("The Pink Sheet" July 20, p. 6). Several other measures made some progress through the legislative maze but were not enacted. Congress must start from scratch on these issues when the 103rd Congress convenes in January. Among the now-defunct bills are: biotechnology process patent legislation -- while S 654 cleared the Senate in September, House sponsors of the similar HR 1417 were unsuccessful in their attempt to get expedited House consideration of the patent issue before adjournment ("The Pink Sheet" Sept. 28, p. 11); orphan drug amendments -- Sen. Metzenbaum pushed S 2060 through the Senate Labor & Human Resources Committee but strong objections by other members, including Sen. Hatch (R-Utah), to the bill's $200 mil. sales trigger/cap stalled the measure. Metzenbaum has vowed to return to the issue next year, expressing optimism that a Clinton Administration might be receptive to his plan ("The Pink Sheet" July 27, In Brief); FDA enforcement -- Rep. Waxman (D-Calif.) and Dingell's (D- Mich.) HR 3642 made it through the House Energy & Commerce Committee in July but no farther ("The Pink Sheet" July 13, T&G- 4). Perhaps the most decisive legislative action to stop a bill was the Senate's 61-36 vote to table, and in effect turn down, Sen. Pryor's (D-Ark.) S 2000 as an amendment to a pending tax bill ("The Pink Sheet" March 16, p. 3). The bill would trim Sec. 936 tax credits for pharmaceutical companies if product prices increase faster than general inflation. Sen. Pryor took the 36 votes for continuing debate as an encouraging first reading on the bill and noted further that some votes to table the measure were based, at least in part, on procedural concerns. Drug pricing got a thorough airing during the Senate's eight hours of debate on S 2000 on March 11. The Bush Administration recently has sped up its fitful progress toward a consolidated FDA campus with prodding from members of Congress, particularly Sen. Mikulski (D-Md.). Congress provided $200 mil. in FY 1992 for initial site planning and land purchase for the two-site consolidated campus, but the Office of Management and Budget balked at purchasing new federal land. OMB and the General Services Administration agreed in late September to identify by Oct. 27 existing federal land for FDA or else purchase at least 127 acres in Montgomery County, Md. to house two of FDA's drug and medical device labs and related offices. Additional land must be identified or purchased for the biologics lab. House and Senate appropriations committees set FDA's FY 1993 budget at $746 mil. for salaries and expenses, $25 mil. for rental payments and $8.4 mil. for buildings and facilities costs ("The Pink Sheet" Sept. 7, In Brief).

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