Medical Device Daily Washington Editor

A 31-page report on FDA audits of good laboratory practices (GLPs) for devices published yesterday by the Project on Government Oversight (POGO, Washington) charges that the Center for Devices and Radiological Health has "decided to ignore the long-standing" GLP regulations, but the report's author also acknowledges the resource crunch at FDA.

The crux of the matter for CDRH may have been whether it should focus its limited resources on GLP audits or on clinical trials and post-market studies, a decision that seems to have landed squarely in favor of those latter considerations.

The author of the POGO paper, Ned Feder, MD, formerly with the National Institutes of Health, gives FDA the benefit of the doubt in at least one passage, which states, "for years, the agency has been underfunded, understaffed and overworked." Still, Feder criticizes the agency's unofficial policy of not enforcing GLPs for device testing as "stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations."

In the report's conclusion, Feder notes that "excessive regulation by FDA is a potential risk that should be kept in mind," but nonetheless argued that enforcement of GLPs "is clearly a necessary government function and should not be supplanted by a system in which manufacturers set their own standards and police themselves."

The report sidetracks into a description of the 510(k) process, which it termed "cheap and quick" and requiring "little effort by either FDA or manufacturers." Feder also describes the Supreme Court case of Riegel v. Medtronic, as having "eliminated the possibility that parties injured by defective devices will be able to file lawsuits in state court" without making the distinction between 510(k) and PMA devices in this context.

The Supreme Court ruling in Riegel applied only to PMA devices, and pre-emption for 510(k) devices was overturned more than a decade ago.

The portion of the report addressing 510(k)s hinges on whether the GLP issue applies to these devices. On page 18 of the report, Feder states that while the question is as yet "an open issue," POGO's position is essentially that "there is good reason to believe" the requirement does apply to facilities making 510(k) devices.

The report states that the decision to let the number of GLP inspections drop was made clear in a May 2007 meeting of the Society of Quality Assurance (Charlottesville, Virginia) at which Matthew Tarosky, a pharmacist at CDRH, presented a slide that stated it is "not feasible to require current [device] manufacturers to follow GLP" requirements, "especially if showing equivalence to predicates." Feder states that POGO wrote to CDRH chief Dan Schultz, MD, about the matter, but that the response "was so evasive as to be almost meaningless."

FDA spokesperson Siobhan DeLancey indicated in an e-mail to Medical Device Daily that CDRH has "in recent years ... not conducted as many inspections specific to GLP as we have in the past," but said also that the agency will "inspect any facility for GLP compliance." In a telephone interview, she told MDD that CDRH investigators had conducted nine GLP audits in 2003, but the number spiked to 19 the following year and to 31 in 2005. In 2006, the GLP audits trended downward to 24, followed by 8 in 2007 and then only one last year.

Feder told MDD that "it's perfectly plausible" that CDRH decided to loosen the audit schedule for GLPs because of resource constraints, assuming that preclinical data appearing in a PMA would reveal any problems. "We have no direct evidence to support any conclusion about the reason the inspections were discontinued," he said. "It's perfectly plausible that they put all their resources into GMP inspections, but we don't know that's why they did it.

"If that is the reason, I would fault them for not making their thinking public," Feder said. However, Feder also made the case that the situation demonstrates "that Congress needs to appropriate more money to FDA."

In a statement e-mailed to MDD, Janet Trunzo, executive vice president for technology and regulatory affairs at the Advanced Medical Technology Association (Washington), said that Feder's report "erroneously claims that all class III devices have the option of being reviewed by the 510(k) process," apparently in reference to a passage in the report which states that the goal of a reform of the 510(k) program "should be the elimination of the 510(k) mechanism for all, or almost all, class III devices." Trunzo states that only 20 class III devices are still eligible for 510(k) review.

Trunzo also states that the report "implies a grave threat to patient safety ... while providing no evidence whatsoever," adding that the effect of the report is likely to be only "to cause needless concern for patients whose lives have been saved and enhanced by devices that have undergone rigorous FDA scrutiny."

Pre-emption sinks second Marquis suit

Federal pre-emption of state liability law for PMA devices is an issue that will surely arise again on Capitol Hill, especially now that another lawsuit has failed on the PMA pre-emption question. According to Associated Press reports, Joseph Blunt Sr. of St. Francis, Wisconsin, lost a suit against Medtronic (Minneapolis) for the failure of a battery in the Marquis line of implantable cardioverter defibrillators (ICDs).

Blunt had the defibrillator implanted in 2004, and the battery issue cropped up the following year, when he opted to have the Marquis removed. His lawsuit was evidently filed based on Medtronic's continued sale of the Marquis after it became aware of the possibility that the batteries were failing in one out of every 10,000 units.

The Marquis line of defibrillators was the subject of a class action that Medtronic settled for roughly $95 million in 2007 (MDD, Dec. 27, 2007). In an e-mailed statement, Chris Garland, Medtronic's VP of public relations for the cardiac rhythm management division, told MDD, "we believe Mr. Blunt was eligible for the settlement, but chose not to participate."

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