New FDA voting procedures are being put in place.
The new procedures, announced April 26, address some of the issues raised by the report. Beginning May 1, 2010, device advisory panels will no longer vote on whether to recommend product approval or conditions of approval. Instead, an FDA spokesperson said in an interview, panels would vote on whether the data included in the product submission provide substantial evidence of safety for the requested indication, plus similar questions for efficacy and benefit/risk ratio.
Until now, panel members who have had reservations about a device frequently would attempt to compromise by supporting it only under certain conditions, such as postmarketing studies or label warnings. However, the FDA frequently doesn’t impose conditions recommended by advisory panels or doesn’t enforce them if they are adopted, Zuckerman noted, adding that many of these conditions are unenforceable or vaguely worded.
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The new rules for advisory panels also extend to the FDA staff members who brief panels on their clinical and statistical review of a medical device under consideration. In a departure from past practice, these scientists will no longer include comments about a product’s “approvability.” Zuckerman said that FDA staffers do not baldly recommend that a product be okayed, but their presentations nevertheless can steer panels in one direction or another.
Steering is also less likely to occur with a provision that calls for more nuanced staff presentations that include a range of opinions and analyses, rather than a unified “consensus analysis.” This approach will allow FDA staff to offer minority reports about a medical device, said Zuckerman, and avoid the appearance that upper management is squelching dissident points of views.
