Study Highlights Impact of Regulations on CEO Confidence

Posted 11 January 2012 | By Alexander Gaffney, RAC 

A research survey conducted by BayBio, The California Healthcare Institute and PricewaterhouseCoopers (PWC) that polled chief executive officers (CEOs) from roughly 100 biomedical companies has found that the overwhelming majority of them feel that the US Food and Drug Administration (FDA) has made it difficult for their respective companies to grow.

Eighty percent of responding CEOs said that the FDA approvals process adversely affected their company's growth plans. The difficulties associated with seeking approval have created capital strains on the companies, 30% of which are seeking venture financing-up from 11% in 2010.

A further 80% of surveyed CEOs did not believe that FDA represented the world's best regulatory system, while 75% believed that another country could take advantage of perceived FDA struggles to recreate a biomedical "ecosystem".

The report cited David Gollaher, PhD, who said that FDA needs to focus on biomedical innovation in order to grow jobs. FDA does not have innovation or job growth in its current congressional mandate.

FDA approvals were up 42% in 2011, with 30 new molecular entities gaining marketing approval.

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