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The Hatch-Waxman Act: A Quarter Century Later


Industry support for pharmaceutical research and development has grown since the passage of the legislation although some recent figures indicate reduced R&D spending by several companies. In the absence of the research, development, and testing performed by the brand name pharmaceutical companies, generic drugs would not exist. The provisions of the Hatch-Waxman Act permit the generic industry to rely on information generated and financed by the brand name companies to obtain approval for their product by the FDA. However, the pharmaceutical industry today differs significantly from what it was in the early 1980s when the legislation was enacted. The cost of developing a drug has doubled, as has the number of clinical trials necessary to file a new drug application. The number of participants required for these trials has tripled. As the rate of return on investments in a new drug declined 12%, manufacturers often spend R&D dollars on developing improved versions of, or new delivery methods for an existing product. Many experts agree that the Drug Price Competition and Patent Term Restoration Act has had a significant effect on the availability of generic substitutes for brand name drugs. Yet, congressional concerns remain whether or not the balance inherent in the act remains appropriate over 25 years later.


THE DOCUMENT INCLUDES FOLLOWING FILES:
# FILE NAME Document Date Order ID: Number of Pages PRICE
1 R41114.pdf Dec 05, 2012 R41114 17 $19.95 ADD TO CART

Older Versions:

The Hatch-Waxman Act: A Quarter Century Later  [Order No: R41114  Release Date: Mar 13,2012  Pages: 17]

The Hatch-Waxman Act: A Quarter Century Later  [Order No: R41114  Release Date: Feb 08,2011  Pages: 17]

The Hatch-Waxman Act: A Quarter Century Later  [Order No: R41114  Release Date: Mar 01,2010  Pages: 17]