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Pediatric Drug Exclusivity Reauthorization Expected In House Before August

Executive Summary

Legislation reauthorizing pediatric exclusivity for drugs is expected to be introduced in the House by Rep. Greenwood (R-Penn.) before Congress' August recess.

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Pediatric exclusivity bill markup

Legislation on reauthorizing the pediatric exclusivity provisions is scheduled to be marked up by the House Commerce/Health Subcommittee Sept. 13. Full committee markup is planned for Sept. 20. Rep. Greenwood (R-Pa.) is sponsoring the legislation, with Rep. Eshoo (D-Calif.) as cosponsor. Rep. Waxman (D-Calif.), who cosponsored the original pediatric exclusivity legislation with Greenwood, declined to cosponsor the reauthorization bill and will offer amendments during markup (1"The Pink Sheet" July 23, p. 7)

Pediatric exclusivity bill markup

Legislation on reauthorizing the pediatric exclusivity provisions is scheduled to be marked up by the House Commerce/Health Subcommittee Sept. 13. Full committee markup is planned for Sept. 20. Rep. Greenwood (R-Pa.) is sponsoring the legislation, with Rep. Eshoo (D-Calif.) as cosponsor. Rep. Waxman (D-Calif.), who cosponsored the original pediatric exclusivity legislation with Greenwood, declined to cosponsor the reauthorization bill and will offer amendments during markup (1"The Pink Sheet" July 23, p. 7)

Pediatric Study Royalty Fund Would Be Created By Wellstone Amendment

Drug companies would be required to set aside a portion of product sales to fund pediatric research for off-patent drugs under an amendment Sen. Paul Wellstone (D-Minn.) will offer to the pediatric exclusivity reauthorization bill when it is considered on the Senate floor.

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