Medical Device Daily Washington Editor

The application for Menaflex collagen made by ReGen Biologics (Franklin Lakes, New Jersey) has been under the microscope by many parties of late, and the FDA yesterday released the results of its investigation into the controversy, reporting that Menaflex will stay on the market for the time being. However, deputy FDA commissioner Joshua Sharfstein, MD, also said there was no guarantee the device will stay on the market pending a review of the device's clinical data.

This decision follows an announcement that the FDA has requested that the Institute of Medicine (IOM; Washington) examine the 510(k) program at FDA, but the agency's representatives who were on the conference call declined to address whether the predicate creep cited in the accompanying report can be addressed in strictly regulatory terms.

Menaflex, a collagen scaffold for the knee, morphed from an IDE filed in 1992 in pursuit of a PMA to a 510(k) earlier this decade, but the sponsor had no luck with the agency's reviewers. The FDA, apparently at the prompting of several parties including Rep. Frank Pallone (D-New Jersey), convened an advisory committee hearing that resulted in a recommendation that the agency clear the product due largely to outstanding safety data, but admittedly iffy efficacy data (Medical Device Daily, Nov. 18, 2008).

Dan Schultz, MD, formerly the director of the Center for Devices and Radiological Health, proctored the meeting, and Larry Kessler, who at the time was director of the Office of Scientific and Engineering Labs at CDRH, represented the agency's reviewers.

Pallone and Henry Waxman (D-California) chimed in on the matter earlier this year, urging that FDA give the matter a closer examination (MDD, May 13, 2009), with no apparent cognitive dissonance over Pallone's role in the device's successful clearance. Pallone chairs the health subcommittee for the House Energy and Commerce Committee, which Waxman chairs. Pallone is widely believed to be working on legislation addressing the program, but recent efforts by MDD to obtain information on the legislation have been unsuccessful.

The Menaflex 510(k) got a thumbs down from the director of the Office of Device Evaluation, Donna-Bea Tillman, PhD, as well as from reviewers, but they were overruled by the recently departed Schultz, whose resignation is widely thought to be driven in substantial part by the Menaflex flap. Also weighing in on the firm's behalf was former FDA commissioner Andrew von Eschenbach, MD, who later characterized the 510(k) program as being "out of control."

One of the results of the intervention by Pallone, Schultz and von Eschenbach was that the composition of the orthopedics and rehabilitative devices advisory committee was revamped to include several sports orthopedists, presumably an indicator of the device's intended market. Despite that, the Centers for Medicare & Medicaid Services recently announced it would undertake a national coverage analysis for the device, although ReGen asserts it has not requested a coverage review and that it is unaware of any use of the device in a Medicare population (MDD, Aug. 31, 2009).

Sharfstein said on a Thursday conference call that the review was conducted "out of concern that we were made aware of by Congress and the media," prompting him to ask several senior managers "to lead a review of this process targeted at several questions," including whether established procedures were followed.

"There were in fact numerous departures" from standard operating procedures, Sharfstein acknowledged, adding that the report "makes a series of recommendations all of which will be adopted," including the IOM review of the 510(k) program.

On the other hand, the report notes that reviewers also deviated from procedures, including that they returned a decision deeming the Menaflex not substantially equivalent to the predicate on the first 510(k) review, an action that Tillman confirmed to MDD as being contrary to standard practice.

Another action the agency will undertake in response to the review is that the Office of the Commissioner will henceforth include an individual charged with dealing with concerns expressed by industry and by reviewers, which presumably does not mean the ombudsman office at CDRH, a slot currently held by Les Weinstein.

"The message is that there were problems with the integrity of the decision making process," Sharfstein noted, but he added that those problems "have solutions."

Regarding the Menaflex, Sharfstein said "we are going to re-examine that question (of safety) because it's the right thing to do," although he acknowledged that the conclusion of the review might be that "the decision was sound after all."

One of the questions addressed in the FDA's report on the topic is that of predicate creep, and MDD asked what FDA could do to restrict this aspect of the 510(k) program without a change of statute. Shuren said on the call that "this is one of the issues we're looking for answers from IOM" and declined to comment further.

Mark McCarty, 703-966-3694;