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'FDA focus on safety' makes new drug projects difficult, it is claimed
02 Jul 2008
It is now more difficult for pharmaceutical companies to bring new drugs to the market, it is claimed.
Schering-Plough's chief executive Fred Hassan believes the US Food and Drug Administration (FDA) has a new focus on safety and less tolerance of side-effects, the Wall Street Journal reports.
Last year, the FDA approved the fewest number of new medicines for 24 years and announced about 75 new or revised "black-box" warnings about potential side effects, which is twice the number in 2004, according to the news provider.
It says Ira Loss, senior healthcare analyst at research company Washington Analysis, concurs with the view that the FDA is now "more safety-oriented than it has been in years".
However, it states director of the FDA's Centre for Drug Evaluation and Research Janet Woodcock denies the agency has become increasingly conservative on drug safety, adding the increase in black-box warnings is mainly due to the relabelling of a few large groups of medicines.
Last week, Schering-Plough and Merck revealed the withdrawal of their new drug application for the loratadine-montelukast combination tablet.