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GAO Criticizes Genomic Tools for Adding Cost but Not Productivity to Drug Development

NEW YORK (GenomeWeb News) — The Government Accountability Office, the federal watchdog for government spending, said genomic technologies have reduced drug-development productivity while adding to R&D costs in recent years.
 
In a report it issued last month, “New Drug Development: Science, Business and Intellectual Property Issues Cited as Hampering Drug Development Efforts,” the GAO criticizes the slow pace and high costs of drug development and in one section blames genomic technologies.
 
“Over the past decade, new technologies including genomics and high-throughput screening have provided tools for researchers to discover and test compounds,” according to the report. “According to industry analysts, the use of these technologies has led to increasing expenses without a commensurate increase in the number of drugs developed.
 
“These analysts have found that although companies have invested substantial resources in acquiring technologies that have generated vast quantities of newly discover biological data, company researchers are still learning whether the data will lead to potentially valid drug candidates, resulting in compounds and drugs that have failed in either preclinical or early clinical testing.”
 
The report also states that in general over the past several years “it has become widely recognized throughout the [drug development] industry that the productivity of its research and development expenditures has been declining; that is, the number of new drugs being produced has generally declined while research and development expenses has been steadily increasing.”
 
Specifically, it states that approximately one out of every 10,000 chemical compounds initially tested for their potential as new medicines is found safe and effective, and eventually approved by the FDA, “making the drug discovery and development process complex, time consuming and costly.”
 
It did not say how genomic technologies factor into those figures.
 
The complete report can be found here.

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