[Ip-health] House Dems Announcement of GAO Report on Drug Development

[Mike Palmedo]

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[ Picked text/plain from multipart/alternative ]
Fact Sheet on Drug Development
 http://www.democrats.reform.house.gov/Documents/20061219112943-24453.pdf

 GAO Report on New Drug Development
 http://www.democrats.reform.house.gov/Documents/20061219094529-73424.pdf

 Press Release
 http://www.democrats.reform.house.gov/Documents/20061219111733-59654.pdf


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 http://www.democrats.reform.house.gov/story.asp?ID=3D1148

 GAO Analysis Refutes Industry Myths About Drug Development

 House Committee on Government Reform (Democrats)
 Tuesday, December 19, 2006

 Rep. Waxman, along with Sens. Durbin and Kennedy, today released a new
 GAO analysis revealing a decline in new drug development by the
 pharmaceutical industry. The report contradicts the myth that higher
 research expenditures have resulted in more treatment options for patients=
.

 * Research breakthroughs have failed to keep up with R&D funding.
 Between 1993 and 2004, pharmaceutical R&D expenses increased from $16
 billion to almost $40 billion, a 147% increase. Over the same time
 period, the number of new drug applications (NDAs) has increased by only
 3 8 %, and the number of applications for potential breakthrough drugs
 (new molecular entities, or NMEs) has increased by only 7%. In both
 cases, the number of applications has declined since 1999.

 * The majority of drug applications are for non-breakthrough drugs. Only
 32% of drug applications are for NMEs; only 12% of drug applications are
 considered by FDA to be =93priority=94 NMEs.

 * Patent law loopholes discourage innovation. The ability of drug
 manufacturers to easily obtain patents for minor changes to products, or
 to receive patent exclusivity for new uses of existing products, have
 reduced incentives to develop new drugs.

 The panel of experts convened by GAO recommended increased collaboration
 among government, industry, and academia in the drug development proces
 and in the development of scientists who can translate scientific
 breakthroughs into practical results . The panel also indicated that the
 government could consider provid ing additional financial incentives =97
 such as longer patent lives for innovative drugs and shorter patent
 terms for =93me-too=94 drugs =97 to shape the drug development process.