By Dana A. Elfin
In a loss for the Washington Legal Foundation, the Food and Drug Administration Feb. 21 rejected the group's citizen petition asking that the agency be barred from using advice or recommendations from an Institute of Medicine panel on potential changes to a key medical device clearance program.
The 510(k) process is how most medical devices reach the U.S. market and it has come under criticism from device industry stakeholders, who have said it is overly complicated and unpredictable. In September 2009, the agency commissioned the IOM to conduct an external review of the 510(k) program (3 MELR 668, 10/7/09). The IOM panel criticized 510(k), but industry stakeholders faulted the IOM committee, saying it lacked expertise on device approvals (5 MELR 563, 9/21/11).
A 510(k) is a premarket submission for lower-risk devices made to FDA to demonstrate that the new device to be marketed is “substantially equivalent” to a predicate device that is legally marketed in the United States. Manufacturers must compare their new device to one or more similar legally marketed devices to support its substantial equivalence.
In late June 2011, WLF filed a citizen petition with FDA, arguing that FDA's use of advice or recommendations from an IOM committee for the agency's 510(k) premarket notification process would violate a provision of the Federal Advisory Committee Act, because the committee's membership was not “fairly balanced” as FACA requires (5 MELR 445, 7/13/11).
In a letter signed by Leslie Kux, acting assistant commissioner for policy in the Office of the Commissioner, FDA rejected WLF's suggestions that FDA either continue its own review of the 510(k) program without IOM input, or have IOM reconstitute its committee to comport with FACA's fair balance requirement.
In the letter, Kux said the agency “is not required to make an independent determination concerning whether the membership of the convened advisory committee satisfies the FACA fair balance standard.” Instead, Kux said, FDA may “rely on the certification the IOM provided to FDA … that the relevant policies and procedures substantially have been complied with in the IOM's selection of the IOM 510(k) Committee membership.”
Moreover, the agency said, “[e]ven if it were FDA's role to determine whether the IOM 510(k) Committee was fairly balanced,” FDA said it did not agree with WLF's claim that the IOM was not fairly balanced. “The Petition's main complaint,” FDA said, “is that ‘no member has experience in the critical area of using the 510(k) program to gain FDA approval for the marketing of innovative products.' ”
But, the agency stressed, FACA requires that the committee be fairly balanced “for the functions to be performed.” And, FDA said, given the committee members' various areas of expertise and the “two very broad questions” they were asked to tackle, the IOM 510(k) committee was fairly balanced for what it was asked to do.
The IOM panel was composed of 12 members, including five doctors, three lawyers, and several academics with a variety of technical backgrounds.
FDA also declined WLF's request to issue a guidance document that would help other advisory committees comply with the fair balance requirement and avoid a similar situation when FDA might not be able to use an advisory committee's report.
“FDA,” Kux said, “must not manage or control the specific procedures adopted by IOM; a committee created and used by IOM to develop advice or recommendations to FDA must be subject to ‘both actual management and control' by IOM, not FDA.”
In addition, she said, “it is neither necessary nor feasible, in light of the broad range of issues that the agency has taken and will likely take to the IOM for advice and recommendations in the future, to issue the guidance document the Petition requests.”
IOM's report was issued in July 2011 (5 MELR 503, 8/10/11). IOM concluded that the current 510(k) process is flawed based on its legislative foundation, and should be scrapped. Most members of the medical devices industry have roundly rejected the recommendations (5 MELR 553, 8/24/11).
FDA also has indicated that it does not think the 510(k) program needs to be scrapped entirely (6 MELR 38, 1/11/12).
David Nexon, senior executive vice president of AdvaMed (Advanced Medical Technology Association), a devices industry trade group, told Bloomberg BNA that he does not expect FDA to do much of anything with the IOM recommendations.
Meanwhile, in late December 2011, FDA issued draft guidance for industry and staff intended to clarify each of the critical decision points in the process FDA uses to determine “substantial equivalence” of a medical device when going through the 510(k) premarket notification program (6 MELR 9, 1/11/12).
WLF Chief Counsel Richard Samp, Daniel A. Popeo, and Lilia Doibani filed the June 28, 2011 citizen petition for WLF with the pro bono assistance of Robert Klepinski, an attorney from Minneapolis.
A copy of WLF's June 28, 2011 citizen petition is at http://op.bna.com/hl.nsf/r?Open=deln-8rysyn.
A copy of FDA's Feb. 21 denial of the citizen petition is at http://op.bna.com/hl.nsf/r?Open=deln-8rwlss.