Pharma worries as FDA pushes for faster drug approvals

6 October 2017

Life sciences companies are facing familiar business risks, according to their most recent 10-K filings. But revolutionary forces - driven by innovations in technology, regulatory bodies, consumers, legislators and healthcare providers - will require new ways of thinking about risk mitigation.

According to the 2017 BDO Life Sciences Risk Factor report, which analyzes risk factors listed in the most recent 10-K filings of the largest 100 publicly traded life sciences companies on the NASDAQ Biotechnology Index, the industry’s worries around both are heightened. Findings include:

Nearly all (98%) of life sciences companies are concerned with FDA regulatory approvals, obligations and compliance, including limitations on approved products, compared to 97% last year and 94% in 2013.
Most (84%) cite pressure on pricing and margins, and cost-cutting, down slightly from last year’s 89% but compared to 79% in 2015, 68% in 2014 and 66% in 2013.

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