GAO's Crosse Explains Report Criticizing FDA's Management of Device Recalls

When it comes to managing medical device recalls, FDA could do better.

That’s the conclusion that the Government Accountability Office (GAO) reached in a June report evaluating FDA’s handling of the recall process. The watchdog group found that FDA is inconsistent and slow in overseeing recalls, and that it is not properly analyzing and collecting recall data.

Given access to FDA’s recall enterprise system (RES), which is what the agency uses to store recall information, the GAO evaluated all recalls initiated between January 1, 2005 and December 31, 2009. Excepting product withdrawals, companies initiated 3510 recalls in that period. Almost 83% were Class II recalls, which are for problems that represent a moderate risk; 14% were Class III recalls (problems that represent a low risk); and 4% were Class I (the highest risk level). The GAO also took a closer look at 53 of the Class I recalls that were initiated during this period.

Among the issues that the GAO found: FDA was taking twice as long to terminate recalls as it was supposed to, averaging 192 days to complete a process that FDA says it should be able to finish in three months. While 59% (2050) of the recalls initiated during that period had been terminated, the GAO found that 36% (1268) were still ongoing and 5% (192) had been completed but not yet terminated.

The GAO also identified issues with the agency’s implementation and application of oversight. When a firm issues a Class I recall, FDA is supposed to inspect the company’s establishment, but this only happened in 20 of the 53 Class I recalls examined. While the agency did perform audit checks on a relatively high number of Class I recalls (45 of the 53, or 85%), the GAO found that the audit checks were inconsistently carried out. FDA’s investigators had different criteria for determining whether a firm had completed an effective recall, and some investigators failed to ensure that problematic recalls were effective. In addition, the GAO is concerned that the audit checks were “too narrow in scope,” requiring investigators to contact just 2–10% of users or customers affected, and that the assigned number of audit checks were not always performed. These gaps can, the GAO says, result in faulty devices being left on the market.

“We were seeing a fair amount of inconsistency across the recalls that we examined in greater depth, and we think that FDA needs to do more to train its people, to provide guidance to its people, and to oversee how the recalls are being carried out on their part,” says Marcia Crosse, director of healthcare at GAO and the primary author of the report.

The report focused on the agency’s failure to analyze recall data. The GAO found that FDA staffers “were basically treating each [recall] as an individual case, and not looking to see if there were patterns,” Crosse says. The agency is, the GAO says, missing a chance to identify patterns that could reveal systemic issues.

Crosse attributes the problems to a combination of factors. “I think for a very long time, FDA’s responsibilities have been expanding at a faster rate than their funding,” she says. While the agency has been relatively well-funded when it comes to carrying out premarket review, she says, the postmarket side has not been similarly supported.

She also partly blames a lack of commitment to improving the recall process at the agency. “Some of it is kind of a management commitment to analyze the information that’s available to them,” Crosse says. “That’s not primarily a resource problem.”

Crosse says that she wasn’t surprised by the results of her agency’s investigation.

“Unfortunately, it was all too consistent with some of the same kinds of findings we’d previously seen at FDA,” Crosse says. “I think we were not seeing sufficient progress across time."

A written response from HHS was attached to the report as an appendix. In it, HHS generally agreed with the GAO’s assessment of FDA and what it needs to do to improve. While Crosse says she was satisfied by this response, in her opinion, it is far from enough. The promises, Crosse says, are “not sufficient for us to say that it’s all taken care of. We will be tracking our recommendations.”

FDA officials did not respond to a request for comments. However, Stephen McConnell, an attorney who specializes in product liability for Dechert LLP, defended the agency.

“I think it is good that there are people who come in and kind of apply a little rigor to the process,” McConnell says. “I guess my big concern is that [the GAO’s report] ends up getting misinterpreted or even distorted.”

McConnell is worried people will conclude FDA is incompetent based on the report. “I wish the GAO would actually put a few more hortatory comments in their report making clear what I think is what they mean to say, which is that this organization that they’ve audited does a very fine job,” he says, “but like every other entity, or every person, there’s always room for improvement.”

McConnell says that he anticipates plaintiffs’ attorneys using the GAO report to paint FDA’s regulatory process as untrustworthy, a ploy that he says could play into many people’s preconceptions about the government.

He also wonders if some on FDA’s staff do a better job handling and analyzing recalls than the GAO recognized. He’s concerned that the GAO’s comparative lack of expertise might have kept it from realizing the true effectiveness of FDA’s efforts.

“When the GAO folks say, ‘You ought to be taking this recall data and you ought to be using it more proactively,’ I bet that there are people at FDA… [who are] probably doing it,” McConnell says.

Crosse responded in a follow-up e-mail, reiterating that the GAO thoroughly examined the documentation and information available for the recalls it investigated. “It is important to note that we discussed [our findings] in detail with FDA and gave the agency the opportunity to comment,” Crosse writes. “FDA did not present us with any compelling evidence to contradict our findings, nor did it, as Mr. McConnell wonders, assert that it was doing a better job than it was able to prove. FDA agreed with our findings, conclusions, and recommendations.”

Regarding the probability that FDA staff members are already using recall data proactively, Crosse writes that “FDA officials appeared to be unaware of RES’s capability to generate summary data and therefore were not doing any independent analysis of their own.” She adds that FDA staff “told us that they had not analyzed their own data and, at most, could only speculate about what we found—even on such general topics as common causes of recalls and the length of time needed for firms to complete recalls.”

Larry Pilot, an attorney who specializes in medical device law and who has worked at FDA in the past, feels the report focused on the wrong aspect of the recall process. He is concerned that CDRH does not classify recalls correctly from the beginning, and says the GAO should have evaluated that.

“To me, [the health hazard analysis] is the core, the heart of the process,” Pilot says. “The rest of it is the circulatory system.” If the recall is classified incorrectly, then the rest of the process is suspect, he says, regardless of how well the steps are carried out.

Crosse says the GAO’s staff was not qualified to assess recall classification.

“We weren’t going in and doing a major review of whether there’s any issues” with classifications, Crosse says. “We weren’t trying to second-guess whether or not [FDA was] individually classifying recalls appropriately,” she says.