08172017Headline:

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John Bisnar
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FDA Toughens Advisory Committee Guidelines

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After mounting complaints that its advisory committees were dominated by members with drug industry ties, the U.S. Food and Drug Administration has tightened it rules on just who will be allowed to offer advice, according to a report on the Consumeraffairs.com Web site this week.

Under its draft guidance, advisors who receive money from a drug or device maker would not be allowed to vote on issues involving that company. At the same time, those who receive more than $50,000 from a company or competitor whose product is being considered would be barred from serving on committees.

The move is likely to be viewed as a retreat from FDA’s previous position, defended as recently as last July. The agency is accepting public comments on the proposal for the next 60 days.

“FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Randall Lutter, FDA’s acting deputy commissioner for policy.

Under the proposed new guidelines, if an individual has disqualifying financial interests whose combined value exceeds $50,000, the person may not participate irrespective of his or her expertise on the matter that’s being discussed. If financial interests amount to $50,000 or less, he or she may be recommended to participate as a non-voting member. And only those with no potential conflicts would be eligible to fully participate as voting members of the agency.

I’m happy about these new guidelines. When I first became aware of the prevalence of apparent conflicts of interests in the FDA, I was shocked. Not any more. And this isn’t the only federal agency operating this way. There are many others.

So why haven’t these rules been in place since the begining of the FDA? Who has been benefiting from the “foxes guarding the hen house”? Does anything smell here?

If City Council members cannot vote on a development in their city if they had a vested interest in it, why do we have drug company shills making decisions in the FDA?

Why don’t the same conflict-of-interest rules that apply to our municipal government not apply to a federal agency? Shouldn’t an agency that makes decisions about our health and safety be held to an even higher standard than the local city council?

A guess the present administration in Washington who makes all the appointments just knows what’s better for us than we do.

Tell me what you think.