Medical Device Daily Washington Editor

WASHINGTON — If the 110th Congress is known for intervening in FDA's work, it's usually from the Democratic side of the aisle, but an ongoing dispute between FDA and a maker of artificial replacements for portions of the frontal skull has brought members of the GOP into the fray.

The dispute, by some accounts, commenced in 1999, when TMJ Implants (Golden, Colorado), filed a PMA with the agency for its partial and total prostheses for the temporomandibular joint. According to a June 1, 2007, letter to FDA Commissioner Andrew von Eschenbach from Roland Jankelson of Lakewood, Washington, formerly the president of hearing-aid maker Myotronics (Kent, Washington), the dispute began due to "the actions of senior FDA reviewer Susan Runner [which] were tainted with multiple conflicts of interest and personal agendas."

The company's products were "removed from the market for a protracted period," according to Jankelson's letter, and the PMA was then reviewed by Bernard Statland, MD, "who immediately overruled Dr. Runner and Tim Ulatowski." Ulatowski, who now directs the Office of Enforcement at the Center for Devices and Radiological Health, was at the division of dental devices at the time. Statland died of a brain tumor in 2004.

FDA has written the company three untitled and two warnings letters for, among other things, failure to report incidents as medical device reports (MDRs), and Jankelson states that TMJ sought to "work with the agency to obtain clinical input from persons within the agency with some reasonable level of expertise ... to obtain understanding of the correct application of the MDR language to each of these specific cases."

The situation went nowhere, and FDA attempted to impose civil money penalties (CMPs) while TMJ was still working on its appeal.

In an April 14 letter to Rep. Joe Barton (R-Texas), the ranking member of the House Energy and Commerce Committee, Jankelson makes the case that after Statland overruled Ulatowski and Runner, "the treatment of TMJ ... has been motivated solely by the desire for retribution," naming Eric Blumberg at FDA's Office of General Counsel, among others. Jankelson also asserted that enforcement action can, but is not mandated, to take place while an appeal is under way.

A Nov. 14, 2007 letter to the agency from Barton and Rep. Ed Whitfield (R-Kentucky), then the ranking Republican member of the Energy and Commerce Oversight and Investigations Subcommittee, states that they had misgivings about FDA's "use of limited enforcement resources and the adequacy of its dispute resolution process" in this case.

The letter also points out that Congress had brought up a more general problem with FDA's dispute resolution mechanism in 1995, and the FDA commissioner at the time, David Kessler, MD, acknowledged in testimony that when an impasse "hits top management, early on we should have worked better to resolve that dispute."

Barton and Whitfield also state that a July 26, 2007 letter "also raises serious questions as to whether persons outside the agency can have confidence that FDA will engage in good-faith dispute resolutions and not use the dispute resolution process as a way to string individuals or companies along while FDA is preparing an enforcement action."

The Feb. 1 response from Stephen Mason, the agency's acting assistant commissioner for legislation, notes that "FDA's regulation provides that appeals ... do not stay an enforcement action," and that this is because "firms could use the process to shield themselves from enforcement actions or potential adverse judgments" otherwise.

Mason points out that TMJ had received one warning and three untitled letters prior to the 2004 warning letter "detailing similar violations." He states that after extensive correspondence, CDRH had decided that the warning letter would stand as written unless TMJ "would be willing to process the events as MDRs without further dispute if the firm wished to submit the MDRs."

The appeal, Mason states, was forwarded to the Office of the Commissioner in November 2004, but despite the delay of eight months in the office's review, "we do not believe that the firm was prejudiced [against] by this event, nor did the agency in any way benefit by the delayed response." He makes the case that CDRH "made several good faith attempts to reach a reasonable settlement" and that "the firm had the opportunity to have its arguments and defenses fully heard and adjudicated in a neutral and unbiased proceeding, and has continued to operate its business without interruption."

All the same, Barton and John Shimkus (R-Illinois), who replaced Whitfield on the subcommittee, said in an April 3 letter to von Eschenbach that Mason's letter "did not deal with two important policy issues," namely preventing such disputes from escalating and engaging in good faith attempts to resolve such disputes.

The April 3 letter adds that Barton and Shimkus "are also disappointed" in the letter, "because we do not believe this is an accurate reflection of your leadership and the way you would want FDA to conduct itself in its dealings with regulated industry."

TMJ's CEO, Bob Christensen, told Medical Device Daily that the nature of the purported conflict by Susan Runner was that she is "an oral surgeon who trained under the owner of TMJ Concepts," a rival firm based in Ventura, California. Regarding the company's attempt to take the matter to the commissioner's office in 2004, he said the commissioner's office "sat on it for eight months, then served the civil money complaints," after which the commissioner's office said it wouldn't take the appeal due to the imposition of CMPs. At this point in time, Lester Crawford was the FDA commissioner.

Christensen does not expect to get the matter resolved within FDA. "I think the whole thing is so entrenched that there's no way to turn this thing around," he said.

The firm's next options, assuming FDA does not change its mind, is to file suit in the U.S. 10th Circuit Court of Appeals, followed if necessary to the U.S. Supreme Court.