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Consumers, Scientists Tell FDA To Explain Agency Decisions

By Jared A. Favole, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- Consumers, doctors and scientists told the Food and Drug Administration Wednesday the public deserves to know more about how the agency makes complex scientific decisions about the medicine and food Americans consume.

Consumers said the FDA needs to more rigorously oversee clinical trials to ensure patients get treated fairly; doctors urged the FDA to flag safety concerns with drugs and devices as quickly as possible; and scientists recommended the agency air dissenting opinions by FDA scientists.

These thoughts were balanced, in part, by industry representatives who said that, while they agree the FDA should explain decisions more thoroughly, confidential commercial information shouldn't reach public eyes.

The meeting is part of an effort underway at the FDA to undermine accusations that it operates like a black box, making decisions without explaining them. The FDA has long faced criticism, some of which was repeated at the meeting, that it sits on safety information that should be public and works too closely with industry.

It's too early to tell what recommendations, if any, the agency will implement. But FDA officials, including Deputy Commissioner Joshua Sharfstein, and the heads of nearly every division within the agency, eagerly questioned consumers and scientists about their recommendations and said over and again they looked forward to reading more details in written testimony.

Steve Findlay, a senior health-policy analyst at the Consumers Union, said the FDA should tell the public, through its Web site, whenever agency officials have meetings with industry representatives. Such disclosure, Findlay said, would help restore the FDA's credibility. FDA officials appeared open to the idea, but questioned what meetings would warrant telling the public about.

Findlay said "important" meetings, but acknowledged the FDA will have to decide what that means.

This highlights a broader challenge the FDA will wrestle with as it decides to make decisions more transparent: What should it release? What can it release? And is there such a thing as 'too much information'?

For instance, Francesca T. Grifo, of the non-profit Union of Concerned Scientists, said the agency should allow FDA scientists to publicly air opinions about a drug or medical product when they disagree with a final agency decision.

Sharfstein questioned such a move, saying scientists often "disagree sharply," and airing those differences might erode the public's trust in FDA decisions.

"I don't think that the idea that we might confuse someone is powerful enough to actually silence an opinion that might in fact save a life," Grifo said.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@ dowjones.com

  (END) Dow Jones Newswires
  06-24-091553ET
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