By Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, Thomas F. Boat, Marilyn J. Field

Rare illnesses jointly impact hundreds of thousands of usa citizens of every age, yet constructing medicines and scientific units to avoid, diagnose, and deal with those stipulations is tough. The Institute of drugs (IOM) recommends enforcing an built-in nationwide technique to advertise infrequent ailments examine and product development.

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All rights reserved. Rare Diseases and Orphan Products: Accelerating Research and Development 10 RARE DISEASES AND ORPHAN PRODUCTS and to generate profits because public and private health insurance plans and patients and families will pay that price, then a manufacturer may not be deterred by a small target market. Public and private health plans that cover orphan drugs generally lack leverage to negotiate prices in the absence of alternative brand-name or generic products. The most expensive orphan drugs cost more than $400,000 per year.

HISTORICAL AND POLICY CONTEXT Creating Policy Incentives for Product Development The development of significant drugs of limited commercial value represents an activity in the public interest calling for the combined support of government, industry, voluntary organizations, and others concerned with health care. In our society, it should be possible to provide assistance to small groups of patients as well as the general population, and to encourage research on medical problems of limited scope which may later have great beneficial effect.

Several proposals have been introduced in response to such concerns. In 1990, Congress passed legislation that would have limited market exclusivity in some circumstances, but the President vetoed it (Schact and Thomas, 2009).  In 1993, the National Institutes of Health created the Office of Rare Diseases to promote research on rare conditions and help develop a more systematic strategy for such research. Congress provided statutory authorization for the office in 2002 and directed it, among other  References to NIH in this report refer (unless otherwise specified) to all programs of the NIH, which is composed of 27 research institutes and centers.

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