Medical Device Daily Washington Editor
FDA reported that it will convene the orthopedics and rehabilitative devices advisory committee to take another look at the 510(k) application by ReGen Biologics (Franklin Lakes, New Jersey) for the Menaflex collagen scaffold for use in the meniscus of the knee. However, the Menaflex, which by now has to rank as the most famous of all 510(k) applications, was also the subject of a proposed decision memo released last week by the Centers for Medicare & Medicaid Services (CMS) declaring, the device not reasonable and necessary for the Medicare population.
CMS had reported its intent to review the Menaflex in August (Medical Device Daily, Aug. 31, 2009), and the proposed decision memo notes that at least in one instance, researchers expressed the view that “it has become clear that procedures that preserve the meniscus have significant long-term advantages for the patient.“
However, that article, authored by a pair of researchers at the University of California at San Francisco (San Francisco) appearing in the Journal of the Academy of Orthopedic Surgeons in 1993, addresses patients under the age of 50. CMS also notes that repair of injuries resulting from degenerative states do not enjoy the widespread support that doctors generally offer for repairs of acute damage to the meniscus. Hence, the agency proposes no coverage, a decision that forbids local carrier reimbursement as well.
CMS's interest may stem from the notion that degeneration of cartilage in the knee is associated with a need for knee replacement surgery in Medicare beneficiaries, an increasingly common procedure and one of the more costly procedures Medicare covers.
FDA said last year that it would take a fresh look at the 510(k) (MDD, Sept. 25, 2009), but did not state at the time that it would reconvene the advisory committee on the matter. The upcoming hearing, slated for March 23, is presumed to offer a different advisory committee membership than reviewed the application on the first go-round in 2008 (MDD, Nov. 18, 2008). The first panel featured several sports orthopedists that were included at the firm's behest with help from the New Jersey delegation to the U.S. House and Senate, a group that includes Rep. Frank Pallone (D-New Jersey), chairman of the health subcommittee of the House Energy and Commerce Committee.
Pallone has since threatened legislation to tighten the 510(k) process, although he has produced no such legislation. As for the composition of the upcoming advisory committee meeting, FDA has not yet posted the roster of the upcoming meeting.
Gerald Bisbee, Jr., chairman/CEO of ReGen, told MDD, “We don't have any data on the product's use in the Medicare eligible population“ and that while “we have more experience in Europe, rarely is it used, if ever, in someone 65 and older.“ He said the company is of the view that “it's not something the surgeons think about in that age“ and that hence, “it's a little bit of a head-scratcher why CMS took the initiative“ to produce a coverage analysis.
As for FDA's activity, Bisbee said, “I have no idea what's going on here,“ but he said he sees no basis for rescission. “I feel like the company is a poster child for the 510(k) program concerns at FDA,“ he said.
Patent reform back in play in Senate
Patent reform legislation is yet again back in the news with last week's announcement that the Senate Judiciary Committee will take another crack at the bill. In a Feb. 25 statement, Sen. Pat Leahy (D-Vermont), who chairs the committee, thanked Sen. Jeff Sessions (R-Alabama) “for working with me on what has been a top priority of this committee – patent reform legislation.“
Leahy said in the statement, “we have reached a tentative agreement in principle that preserves the core of the compromise struck in committee last year with the help of Senators Feinstein, Specter, Cornyn, Klobuchar and others.“
Leahy committed to “continue discussing the details with all members of this committee . . . as well as with our counterparts in the House,“ and said he wants to “particularly thank Senator [Orrin] Hatch, who has been a longtime partner of mine on intellectual property issues,“ possibly a reference to the inequitable conduct issue. He said the committee has “consulted with the Patent and Trademark Office at the suggestion of Senator Kyl, and with his help and that of Director Kappos, we have the principles of an agreement that will move this legislation closer to passage.“ This latter statement suggests that a compromise has been reached on post-grant review.
Leahy said he expects “that we will be able to release details as they are finalized in the coming days, after consultation with the House.“
Tom Novelli, director of federal affairs for the Medical Device Manufacturers Association (MDMA; Washington) told MDD that the association is not privy to the language in the latest version of the Senate patent reform bill, S. 515, but that some details are beginning to emerge. “We have heard that the damages provision ... was preserved,“ Novelli said, “and we have heard there were modifications on the post-grant review part.“ However, he noted that details are hard to come by, adding that MDMA has “heard nothing about inequitable conduct.“
Novelli suggested that the House patent reform bill faces a tough slog. “I think they're not going to acquiesce to what the Senate is proposing,“ especially on damages, he said, adding that MDMA “foresees the House being a challenge.“ Part of this expectation is driven by substantive differences between the House and Senate bills, but Novelli remarked that some House members who voted for a House patent reform bill in 2007 “are starting to step back“ and take another look.
Todd Dickinson, executive director of the American Intellectual Property Law Association (AIPLA; Arlington, Virginia), told MDD “I think we all are eager to see the results of the compromise“ on inequitable conduct and post-grant review, adding that other issues might still be in play. He declined to comment further pending publication of the latest iteration of S. 515.
Mark McCarty, 703-268-5690