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From the General Committee of health and pensions, we are here for a hearing entitled Rare Diseases as providing treatment for patients expediting treatment for parents. I intend to examine regulatory barriers today for drug entry that treat Rare Diseases also known as orphan drugs. The fda defines orphan diseases with the press as is with fewer than 200,000 patients. There are over 700,000 7000 conditions affecting 30 million patients in the u. S. Can 90 of these are serious or life threatening conditions and most have no fda approved treatment. The standard for approval of orphan drugs is similar if not the same as those for more common conditions that take upwards of a decade from the drug to make it from the bench to bedside and costs can be a part of 2 billion, for terminal patients waiting for a cure that may never come or when it comes to late, its simply not an option. Families and patients resort to importation of drugs approved overseas, off label user may turn to dangerous c
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