Diagnostics & Imaging Week Washington Editor

WASHINGTON – The increased scrutiny of FDA advisory committees has the agency jumping to appease its many critics, and the agency held a conference call Monday to announce a set of guidelines to govern the appointment of advisory committee members. However, the voting process was also revised to address some concerns about how votes might be influenced.

Randall Lutter, PhD, the agency's associate commissioner for policy and planning, said on the call "we're announcing a package of improvements designed to enhance decision-making capability." Among the minor improvements is a faster posting of briefing materials he said would allow Internet viewers to find those materials "in two clicks, as opposed to the eight clicks you used to need." The advisory committee portion of the FDA site now has its own page, with only one click needed to find the calendar for advisory committee meetings.

The new voting procedure essentially calls for all panelists to vote simultaneously on approvability, conditions of approvability and so on. This is not an uncommon practice at present and FDA does not propose an electronic voting regime, but some of the agency's critics have cited sequential voting as an area of concern due to the potential for bias induced by more assertive members of a panel.

The guidances also include a set of rules to determine under what conditions an advisory committee should meet. According to Lutter, the guidance in question poses three questions, but the second requirement hints at what many have suspected about such meetings. This requirement states that a meeting will take place if the matter at hand is "so controversial that it would be highly beneficial to obtain the advice of an advisory committee."

Much of the impetus behind this move is that some advisory committees – perhaps most conspicuously the circulatory systems advisory committee – have been called upon numerous times, making life for panel members complicated.

Jill Warner, a policy analyst at the Office of Policy and Planning, said during the conference call, "the guidance on waiver ... incorporates changes from public comments." She noted that FDA is "putting a cap of $50,000 on personal financial interest," but candidates whose interests fall under that number must still be vetted.

Whether the new standards will create recruitment headaches is difficult to say, but Warner said "we certainly see recruitment ... as an important goal and have stepped up recruitment to a significant degree." She said FDA has contacted 280 professional organizations for nominations to the various committees and has posted announcements in the Federal Register to further boost recruitment. "We've received 350 CVs [curricula vitae] at this point" as a result, she said.

As for how to deal with situations in which the panel might not have enough members present to constitute a voting quorum, Michael Orthwerth, PhD, director of the advisory committee on oversight and management staff at FDA, said that a quorum is achieved with the presence of one person more than half the standard membership, but "we can augment with special government employee members," so it's not an issue.

CMS proposes alternate quality test for labs

Clinical lab operators are sometimes no more happy than those making medical devices about the regulatory burden imposed by FDA and CMS, although those burdens are substantially different. So when the director of the division of lab services at the Centers for Medicare & Medicaid Services told attendees at this week's annual meeting of the American Association for Clinical Chemistry (Washington) that the agency would rethink its expectations for lab quality control (QC), the news was at least not the object of lusty boos and catcalls.

Judy Yost, the director of the division of lab services at the Centers for Medicare & Medicaid Services, titled her talk "New Methods for Complying with QC," and started out by reminding lab operators that, as of last December, there were more than 200,000 labs operating in the U.S., describing that as "an astounding number."

While only about 36,000 of that total are subject to lab QC, the task of keeping track of them is still no cakewalk.

CMS has been rethinking lab QC, Yost said, adding, "we have a lot of reasons we thought new QC was necessary," including the advent of new technology "and so much more testing being done in point-of-care settings."

Yost said the idea of "equivalent QC" – which would not apply to waived settings – first appeared in the interpretive guidelines published by the agency in 2004, which she said was "a welcome addition" for many labs. At present, QC requirements include a verification of the manufacturer's performance specification as well as establishment of performance specifications for lab-developed, or home-brewed, tests.

Calibration is another feature of lab QC, as are daily quality control checks using two levels of external control materials. Those controls can be obtained from providers or made in-house, and can also be drawn from previously tested patient specimens.

CMS is offering three equivalent QC (EQC) options to the traditional QC regime. For instance, analytical equipment that has internal monitoring systems for all analytical components can scale back their QC tests with external controls to once per calendar month with two levels of controls if that system can go 10 consecutive days under daily without going out of spec. The other two options address systems with some internal analytic controls and those with none, all with the idea that tests can be scaled back so long as the lab can demonstrate that the systems behave in a stable fashion.

However, Yost noted that "labs will need more information from manufacturers" regarding the internal controls, and warned attendees that "one-size-fits-all won't work for all test systems."

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