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US government advisers urge FDA to speed up drug approval process

Calls for greater partnership between public and private sectors

FDA headquarters White Oak

The number of innovative new medicines approved in the US should be doubled within the next 10 to 15 years, according to advisors to the US government.

The President's Council of Advisors on Science and Technology (PCAST) has released a report that calls for the Food and Drug Administration (FDA) to accelerate the rate of drug approvals, while increasing drug safety at the same time.

To do this, two key issues need to be address, said the Propelling Innovation in Drug Discovery, Development, and Evaluation report.

First, researchers need to improve their methodologies and tools in order to more appropriately translate clinical research into research that addresses actual therapeutic needs.

In addition, pharmaceutical companies and regulators, such as the FDA, need to “incorporate new efficiencies” into clinical trials, with the Pharmaceutical Research and Manufacturers of America (PhRMA) reporting that one medicine takes, on average, 10 to 15 years to develop at a cost of about $1.2bn.

To achieve these goals, the PCAST has recommended the creation of a public-private collaboration called Partnership to Accelerate Therapeutics.

This would involve representatives from the pharma industry, as well as academic researchers, healthcare professional organisations, advocacy groups and the US government.

According to the PCAST, such a partnership would identify actions that could be taken to speed up the drug development process, minimise the duplication of efforts and appease all stakeholders.

“With improved collaboration among all the participants in the drug development ecosystem and optimisation of drug-evaluation pathways, American researchers and companies should be able to accelerate the development of safe and effective drugs while also strengthening the US economy,” said Eric Lander, co-chair of the PCAST.

The call comes despite research demonstrating the FDA is leading the way, both in the number of drugs approved and the speed of approval, compared to its counterparts in the EU and Canada.

27th September 2012

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