Malek Essay

1528 words - 7 pages

Seoane-Vazquez E., Rodriguez-Monguio R., Szeinbach S.L., Visaria J. (2008, December 16) Incentives for orphan drug research and development in the United States. Orphanet Journal of Rare Diseases, Vol.3(1), p.33. Retrieved November 11, 2013, from

Seoane-Vazquez, Rodrizuez-Monguio, Szeinbach, and Visaria looked at orphan drug designations from the FDA and analyzed how long it took for an orphan drug to be approved by the FDA (4.0 ± 3.3 years), how long the average patent and market exclusivity was (11.7 ± 5.0 years), as well as how market exclusivity affected the average patent and market exclusivity (+0.8 years). They also analyzed the extent to which government incentives helped to create more orphan drugs. It was found that grants, fee waivers, tax incentives, as well as market exclusivity provided a good platform for further research and development of orphan drugs. This article is reliable, it was printed in a peer-reviewed journal and provided good insight to understanding the development of orphan drugs. I plan to use this article to show what current incentives there are for drug companies and research facilities when developing orphan drugs. I plan to use the background section mostly, since it talks about the incentives that are there for orphan drug research and development.

Silverman, E. (2013, March) Tiger in the Fiscal Room: Beware the Increasing Cost And Number of Orphan Drugs. Managed Care, Vol.22(3), pp.10-4. Retrieved November 11, 2013, from:

The cost of orphan drugs is assessed in this article, it points to the fact that "the costs of orphan drugs and other biologics are rising 20 percent to 25 percent a year". It also looks at the fact that five of the most recently approved drugs will cost upwards of $150,000 dollars a year, and three of those cost upwards of $300,000 per year. It also looks at the perspective of different people involved in the payment of these medications, such as insurance companies. If insurance companies deny coverage, then they may have a public relations issue. But with the price of these orphan drugs, and the development of new ones, insurance companies may have to raise premiums in order to compensate for the cost of these medications. This is a useful article because it provides good insight to the costs of some of these orphan drugs, as well as the potential issue of paying for these medications. The source is reliable, and can be used to show the costs of some of these medications. I plan to use this article to show how the use of orphan drugs can be very costly.

FDA (2013, January 18) Summary of NDA Approvals & Receipts, 1938 to the present. FDA. Retrieved November 11, 2013 from:

The main purpose of using this, was to determine how many new molecular entities have been...

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