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FDA makes concessions following criticism

By Simon Pitman , 01-Aug-2006

The FDA has responded to criticisms made by the Union of Concerned Scientists (UCS) that the regulation body is under pressure to exclude or alter technical information on scientific reports that could affect the safety of products.

The agency has announced several steps which it says should 'help to make its advisory committee process more effective at providing timely, top-tier, independent scientific advice'.

The move comes after the USC published the results of a survey it conducted amongst FDA scientific staff which indicates that nearly one fifth of respondents 'have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document'.

The survey also showed that 61 per cent of respondents knew of cases where 'department of health and human services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.'

The results of the survey, which was published on July 20, have given cause for widespread criticism amongst consumer lobby groups and consumers alike who have called for an end to what they see as being influences in the decision-making process that could be detrimental to the safety of products authorized for sale on the US market.

The Public Citizen's Health Research Group says the root course of problem is two-fold.

Firstly there is the fact that the FDA is influenced by significant legislation fees from companies that last year added $380m to the coffers, with the largest contributors making up some of the biggest and most influential consumer companies in North America.

Secondly, and perhaps most influential of all, there is the fact that the FDA is free-standing and not accountable to congress, a fact that leaves the agency more open to outside influences.

But criticism of the agency has not fallen upon deaf ears.

In response to the publication of the UCS report and an ensuing public outcry, the FDA says it is introducing measures that will increase transparency within its advisory committee, which in turn should dispel any assertions that the process is open to non-scientific influences.

""The advisory committee process is integral to examining the intersection between medical practice and clinical research, to spark debate about it, and to subject scientific work to close public scrutiny," said Dr. Scott Gottlieb, FDA's deputy commissioner for medical and scientific affairs.

"Some of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists."

As a result the FDA has issued a guidance outlining the conditions under which conflict of interest waivers may be granted in the hope that any ambiguity will be eliminated from the process.

The agency also says it will try to make information more public about advisory committee meetings as well as issuing a guidance outlining when briefing materials used at advisory committee meetings should be made public.

Any increase in transparency is likely to be welcomed by consumers and consumer groups alike, but to what extent it will make the the FDA approval process more impartial remains to be seen.

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