A Medical Device Daily

Given the intense public and congressional scrutiny FDA is subjected to, it comes as no surprise when the agency take steps to conduct advisory committee procedures with more sunshine. (Its counterparts in Europe hold such meetings behind closed doors.) And the FDA reported last week that it has taken a couple of steps to boost the transparency of the functions of its advisory committees.

Today's MDD food for med-tech thought

"UCLA's results from a very large patient database of 1,302 patients establish beyond question that MRI miss rates of important pathology by static MRI technology are substantial and not inconsequential."

Raymond Damadian, MD, president of MRI equipment manufacturer Fonar (Melville, New York), referencing a research study indicating that dynamic MRI is preferred over static MRI for detecting lumbar spondylolistheses - the slippage of vertebrae in the spine - and for establishing the full extent of vertebral instability. pp. 1, 5

In a statement, Randall Lutter, PhD, deputy commissioner for public policy, said that the FDA's use of advisory committees is one of the agency's strong points, allowing it to "routinely enlist the nation's leading experts to give us public advice on complex medical and scientific issues." The announced revisions "further enhance the transparency and reliability of our advisory committee processes," Lutter added.

One of the guidances deals with the voting procedures used during advisory committee hearings. While the proposed guidance notes that not all meetings require votes — such as those during which clinical trial requirements are discussed — there has nonetheless "been much discussion inside and outside FDA regarding sequential voting versus simultaneous voting."

One of the concerns regarding the process of each member announcing his or her vote in turn is the possibility that "some sequential voters may be influenced, perhaps even subconsciously, by the votes that precede theirs, especially if those votes are identical or signal a clear trend." The document also notes that this risk may be heightened in settings "where votes are often conducted in full view of a passionate public and participatory audience."

FDA recommends that "voting should be done simultaneously... to avoid any potential order bias" induced by sequential voting. The panel chair and the designated federal officer have a choice of simultaneous voting methods, including "a simultaneous show of hands, a simultaneous show of 'yes' or 'no' cards," or a ballot process. In the case of the last scenario, the ballots would be read aloud and attributed to the voter.

The agency also recommends that the focus of each specific vote be thoroughly discussed prior to the vote, but that "the question of the vote should not be the subject of further discussion or clarification while the voting is underway."

The guidance document states that the open comment period runs 60 days, but the document is dated only for the month, November, and not the day.

Conflict-of-interest waivers to be published

FDA also reported earlier this month that it had penned a draft guidance to deal with conflict-of-interest information disclosures and waivers. According to the document, the agency's review of such conflicts as well as comments submitted for the January 2002 draft guidance, "FDA is revising this draft guidance to broaden its applicability, to bring as much transparency as possible to FDA's waiver process, and to increase the consistency and clarity of the process."

The guidance states that prior to each advisory committee meeting, FDA will attempt to obtain the relevant information from each panelist, and any panelist who fails to file the required materials will not participate. FDA will disclose any disqualifying information unless it is "protected from disclosure by statute or regulation."

Any waiver information that is not protected will be published at the FDA web site 15 days prior to the meeting unless the agency receives the data when 30 days or less remain before the meeting date. In that case, FDA will publish the information "as soon as practicable and no later than the day of the meeting."

The announcement says that the declared time frames are "consistent with the requirements" of law, and that the agency intends "to make the disclosure statements and waiver documents public at corresponding advisory committee meetings."

Risk communication panelists named

FDA reported earlier this month that it had selected the panelists for its risk communication advisory committee. The 15 members will "advise FDA about how best to communicate to the public the risks and benefits of FDA-regulated products so as to facilitate their optimal use."

The statement noted the June 5 report regarding the committee drew 240 nominations, "many for exceptionally qualified individuals." Each member will serve on the panel for between one and four years, and "FDA expects to hold the committee's first meeting in the first quarter of 2008."

While the risk communication panel was originally proposed as a way to deal with pharmaceutical safety issues, its mission has expanded before the first meeting. "We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope" to include all products regulated by FDA, including food, according to the agency's deputy commissioner for public policy, Randall Lutter, PhD.

The charter panel chairman will be Baruch Fischhoff, PhD, a professor of social and decision science at Carnegie Mellon University (Pittsburgh, Pennsylvania), and John Paling, PhD, founder and research director of the Risk Communication Institute (Gainesville, Florida).