Orphan Drug Reauthorization Hearing Before the Subcommittee On Health And the

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Orphan Drug Reauthorization Hearing Before the Subcommittee On Health And the
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The administration is concerned about these issues and believes that it is very important that, as we deal with these, we not lose sight of the very beneficial impact that the act has had.
Mr. Chairman, one current issue is well-known to this sub- committee and is addressed in the legislation — a handful of ap- proved orphan products have experienced substantial sales volume. Those products have generated concerns about the act and possibly put its support in jeopardy, and in some cases have pr
...ovided un- necessary assistance to highly successful drugs.
As we evaluate this issue, it is important to remember that the goal of the original act, and the amendments since the act, are to stimulate the development of products of little commercial value to treat rare diseases and conditions and to make them available to people who need them.
As all members of this committee know well, there is a patent system that runs parallel with the exclusivity provisions of the Or- phan Drug Act; and the goal of the Orphan Drug Act is to promote the development of drugs of little commercial value.


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