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Thursday 27th October 2016

US regulator 'must be clean'

28th March 2007

The decision by the United States' Food and Drug Administration (FDA) to exclude experts with significant ties to the industries it regulates is to be applauded, says an editorial in the New York Times.


The new rules may need further strengthening following ongoing consultation, the paper says.

"But even in their current form they look like a big, and long needed, improvement over the agency’s previously lax efforts to screen out conflicts of interest," it adds.

It points to the pharmaceutical industry in particular, which gives out large amounts of money to doctors and academic experts in the form of speaking fees, consultancies, research grants and other financial benefits.

These experts then go on to serve on government advisory committees.

"In one egregious example, a panel that favored marketing the controversial painkillers Bextra and Vioxx would have made the opposite recommendation if the experts with industry ties had been excluded from voting," the paper warns.

The new rules seek to bar anyone whose financial gain from an FDA-regulated sector of industry exceeded US$50,000 from serving on an advisory committee. Those with smaller stakes could serve, but would be barred from voting.

There are still concerns that these restrictions aren't tight enough to prevent some industry influence from making itself felt, however.

What's more, the paper says that since the public’s interests are its only concern, the FDA should be supported entirely by public funds, calling for user fees from the pharmaceutical industry to help finance the drug approval process to be abolished.


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