Funding increases failing to boost FDA drug approvals; research
As pharma approaches its patent cliff companies are looking to ensure their pipelines are able to replace the lost revenues. However, despite significant increases in funding for drug development the number of approvals by the US Food and Drug Administration (FDA) has fallen.
In response pharma has overhauled its internal R&D operations and increasingly turned to contract research organisations (CRO) but these are relatively recent developments and the research, published in PLoS One, covers 1995 to 2005.
Over this period the inflation adjusted increase in expenditure is as much as 369 per cent in one therapeutic area but this is yet to translate into a rise in FDA approvals of drugs or new molecular entities (NME).
The researchers speculate that an increase in the length and complexity of clinical trials is a factor but there have been few signs of improvement beyond the period covered in the paper, with the FDA approving the fewest drugs in 24 years in 2007.
Given current pharma market conditions companies can ill afford to pump money into development programmes that fail to yield products and the researchers suggest non-financial issues should be addressed.
The researchers propose that the cost of clinical trials should be decreased, economic incentives modified to favour high impact, high cost conditions and negative results disseminated openly.
Furthermore, the authors suggest reorganising R&D operations and this process has been initiated at numerous companies, including Eli Lilly, GlaxoSmithKline and Pfizer.
It is too early to asses the success of these actions but their implementation shows that pharma, like the researchers, has acknowledged that money is not the answer to all productivity questions.
The complete research paper can be found here.
