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SEN. METZENBAUM’s ORPHAN DRUG BILL GARNERS INDUSTRY SUPPORT FROM ABC, IMMUNOGEN

Executive Summary

SEN. METZENBAUM's ORPHAN DRUG BILL GARNERS INDUSTRY SUPPORT FROM ABC, IMMUNOGEN as the Senate Labor & Human Resources Committee gears up for a March 3 hearing on S 2060. Association of Biotechnology Companies President Forrest Anthony, MD/PhD, also president of the New Jersey firm Quality Biotech, will testify in favor of the bill, including its $200 mil. sales trigger, in lieu of what he considers more workable proposals. However, ABC advocates also looking at other factors such as the definition of an orphan indication, currently defined as having a patient population of less than 200,000. For example, ABC questions situations where a single product has several orphan indications which each have less than a 200,000 target population but which together exceed that limit. ImmunoGen President Mitchell Sayre is expected to tell the committee that the company supports the legislation due to what it perceives as abuses of the orphan program's intent of spurring development of drugs that would otherwise not be marketed, though it may not strongly endorse the sales trigger approach specifically. ImmunoGen has three versions of its Oncolysin monoclonal antibody immunotoxin under development for a total of five orphan indications, including purging bone marrow during transplantation in B-cell leukemia and lymphoma patients, and treatment of acute lymphocytic leukemia. Metzenbaum will chair the hearing in place of Senate Labor & Human Resources Committee Chairman Kennedy (D-Mass.). Other scheduled witnesses are FDA Deputy Commissioner for Policy Michael Taylor, Industrial Biotechnology Association Chairman and Immunex CEO Stephen Duzan, Pharmaceutical Manufacturers Association President Gerald Mossinghoff, National Organization for Rare Disorders Executive Director Abbey Meyers and Cystic Fibrosis Foundation President Robert Dresing. A hearing convened a month ago by Metzenbaum's Judiciary/Antitrust Subcommittee focused on the senator's contention that some orphan products have "blockbuster" sales, and even with the $200 mil. sales trigger, they could more than recoup their research costs ("The Pink Sheet" Jan. 27, p. 9). With the Labor Committee's legislative jurisdiction over S 2060, the March 3 hearing is likely to address specifically the provisions of the bill itself. The legislation, sponsored by both Metzenbaum and Sen. Kassebaum (R-Kan.), would permit FDA to consider marketing applications from competitor companies when an orphan product's cumulative sales reach $200 mil. Among other industry groups, IBA strongly opposes S 2060 as undermining the incentive offered by the market exclusivity provisions of the current orphan drug law. IBA has noted that biotech companies find the orphan law's marketing exclusivity provisions particularly important since biotech products are sometimes unpatentable. PMA also opposes any changes to current law. FDA has previously opposed approaches such as a sales trigger for orphan products because the agency believes its mandate is generally to focus on safety and effectiveness and not pricing and economic issues.
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