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Congress Asked To Amend Act on Orphan Drugs

WASHINGTON—The Orphan Drug Act, passed in 1983, has been effective in bringing to market new drugs tsrgeted at rare diseases, but more research funds are needed to complete the task and expand it to cover medical foods and devices, federal lawmakers were told this month. In testimony before a House subcommittee on health and the environment, Food and Drug Administration Commissioner Frank Young reported that nearly 160 drugs have been designated as orphans, of which 18 have been approv

Stephen Greene

WASHINGTON—The Orphan Drug Act, passed in 1983, has been effective in bringing to market new drugs tsrgeted at rare diseases, but more research funds are needed to complete the task and expand it to cover medical foods and devices, federal lawmakers were told this month.

In testimony before a House subcommittee on health and the environment, Food and Drug Administration Commissioner Frank Young reported that nearly 160 drugs have been designated as orphans, of which 18 have been approved. (Orphan status gives seven-year exclusive marketing rights to companies as an incentive to produce drugs of potential use to fewer than 200,000 patients.) In the past fiscal year, Young said, the agency spent $4 million in awarding 25 new research grants and renewing an additional 28.

Abbey Meyers, executive director of the National Organization for Rare Disorders, called for an increase in the FDA grants program to $20 million a year....

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