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ORPHAN DRUG BILL FINAL HOUSE VOTE EXPECTED OCT. 22

Executive Summary

ORPHAN DRUG BILL FINAL HOUSE VOTE EXPECTED OCT. 22 to decide on a modified version of the orphan drug bill (HR 4638). The modified version matches a bill by the Senate on Oct. 12. The final amendments relate to the date by which sponsors must have filed for orphan designation to be exempt from the bill's shared exclusivity provision. Prior to amendment by the Senate, the House and Senate versions of the bill were identical. The bill passed the House in its previous form on July 30 ("The Pink Sheet" Aug. 6, T&G-2). The July 30 version of the bill had exempted drugs from mandatory shared market exclusivity if they were in active clinical trials by Aug. 15, 1990 and an application for designation as an orphan product had been filed with FDA by July 15, 1990. Under the amendment, offered by Sen. Armstrong (R-Col.) and co-sponsored by Sens. Hatch (R-Utah), Dodd (D-Conn.) and Lautenberg (D-N.J.), the qualifying date for submission of an application for orphan designation has been extended to the date of enactment of the bill. The drug must still have entered clinical trials by Aug. 15. Warner-Lambert, Glaxo and Johnson & Johnson reportedly were among the firms pushing for the amendment. During Senate debate on the bill, Hatch asked, on behalf of Glaxo, whether the company's nebulized amiloride for cystic fibrosis would qualify for the Aug. 15 clinical trial date requirement if the studies were conducted by a previous sponsor. The drug was earlier studied in clinicals by the University of North Carolina, Chapel Hill. Glaxo plans to conduct additional clinical trials on the drug but "would like assurance...from the author of the bill that the clinical trials conducted by the previous sponsor prior to Aug. 15 will fulfill the requirement," Hatch said. In response, Sen. Metzenbaum (D-Ohio) said "it is the intent of the floor managers of this bill that these clinical trials would fulfill the requirement." The legislation nearing passage would modify the Orphan Drug Act to mandate shared exclusivity for future orphan drugs developed simultaneously. The bill also would authorize FDA to revoke market exclusivity for an orphan product when the treated patient population exceeds 200,000. Although the 200,000-patient limit was designed to address AIDS drugs, it may also affect drugs such as Amgen's Epogen (erythropoietin), which has a potential patient population (anemia associated with chronic renal failure) that has been said to be larger than 200,000. A competitor to Epogen, Chugai/Upjohn's Marogen, was classified by FDA in the summer as "approvable" for the treatment of anemia secondary to chronic renal failure. FDA noted, however, that the drug still faces "outstanding orphan drug issues," which the agency said it expects to resolve "soon."
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