FDA Denies Washington Legal Foundation Citizen Petition

By Jennifer D. Newberger –

In September 2009, FDA engaged IOM, a member of the National Academy of Sciences ("the Academy"), to review the 510(k) medical device premarket review process and answer the following questions: (1) Does the current 510(k) clearance process protect patients optimally and promote innovation in support of public health; and (2) if not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) clearance process optimally? 

The IOM formed a committee to research and respond to these questions.  As a member of the Academy, the committee formed by IOM was required to comply with the Federal Advisory Committee Act of 1972 ("FACA"), which states that an agency “may not use any advice or recommendation provided by [the Academy]” unless the membership of the committee is “fairly balanced as determined by the Academy to be appropriate for the functions to be performed.” 

During the committee’s consideration of the 510(k) process, many interested parties claimed that the committee’s make-up was not “fairly balanced” as required by FACA, in that it did not include anyone from the medical device industry familiar with 510(k) submissions, innovators affected by the pace of review of devices cleared through the 510(k) process, or consumers who have benefited from devices cleared through the process.  Nevertheless, the IOM committee refused to expand its representation.

Building on these stakeholder concerns, in June 2011, the Washington Legal Foundation ("WLF") submitted a Citizen Petition to FDA requesting that FDA issue a determination that it is barred from using any advice or recommendation from the IOM advisory committee, on the grounds that the committee is not fairly balanced and therefore violates the FACA.  The petition also requested that FDA issue a guidance document describing when a committee’s composition is sufficiently balanced to allow FDA to rely upon its advice and recommendation. 

On February 21, 2012, FDA denied the petition on two grounds.  First, it stated that “FDA is not required to make an independent determination concerning whether the membership of the convened advisory committee satisfies the FACA fair balance standard.”  Rather, FDA may rely on the representations of the IOM that the committee was fairly balanced “for the functions to be performed.”  Second, FDA stated that, even if FDA could determine whether the committee was fairly balanced, FDA believes that it was.  FDA also stated that it would not issue the guidance document requested because it is the responsibility of the IOM, not FDA, to determine fair balance.

FDA’s response does not come as a surprise, but its denial of the petition is not likely to have much impact on whether FDA adopts any of IOM’s recommendations.  FDA has clearly stated that it will not adopt IOM’s most controversial recommendation, to do away with the 510(k) process in its entirety (see our previous post here).  Many of the other IOM recommendations have faded into the background and are not expected to substantively influence FDA’s modifications to the 510(k) process.  Thus, WLF may be getting what it wants with regard to this particular issue, even if by different means.

REMINDER: HP&M is hosting FDA Appeals – Improving Your Odds of Success: Trends, Expectations, Strategies, a webinar on March 21, 2012, 12:30 – 2:00 p.m. ET.  Click here to register.