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Published on 23 March 2009

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US drug-approval rethink welcomed

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Breaking up the US Food and Drug Administration (FDA) will speed up the approval process for new medicines, according to an industry insider.

The possibility of two separate agencies, one for food and the other for drugs, arose after food-poisoning outbreaks have reportedly made officials more risk-averse on drug approvals.

Steve Brozak of WBB Securities, an investment brokerage involved in drug and biotech companies said: “Every CEO is in favour of this, but none that value their share prices will go on the record for fear of retribution from the FDA.”

Even before the recent food safety problems, the FDA was under pressure from Congress for failing to catch problems with drugs like Merck’s Vioxx, which was pulled from the market in 2004.

Now, however, President Barack Obama has named two public health specialists to the agency’s top positions and appointed an advisory group to reassess the country’s food safety laws.

The industry regards this as an opportunity to remove the distractions provoked by high-profile food-safety breakdowns that have caused the timescales for new drug approvals to fall behind.

Copyright Press Association 2009

Food and Drug Administration



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