FDA Slammed For Device Review Procedures

Is the FDA failing to properly oversee medical devices? That’s the take-away message from a new report by the US Government Accountability Office, which says the FDA failed to strengthen its approval and recall procedures, despite a 2009 GAO recommendation that “expeditious steps” should be taken to issue regulations for high-risk devices are approved under the 510K process. This is used to determine if a device is substantially equivalent to another marketed device.

Since the last GAO report (read here), the FDA has issued a final rule, but for only one type of device. As of April 1, in fact, agency action on the remaining 26 types of devices is incomplete, according to the GAO. As a result, such devices – including automated external defibrillators and implantable hip devices – can still entering the US market under 510K. This compares with the more stringent pre-market approval, or PMA process, which requires clinical tests and inspections. Yet, the FDA issued expedited reviews to at least 67 devices since the GAO recommendation two years ago.

Meanwhile, there were 3,510 voluntary recalls between 2005 and 2009, but the GAO reports the FDA fails to regularly analyze the recall data, “thus missing an opportunity to proactively identify and address the risks presented by unsafe devices.” The GAO also found “gaps” in the recall process that limit the ability of the FDA and device makers to take needed steps to ensure the “highest-risk recalls” are handled efficiently and quickly.

Moreover, the FDA has not set threshholds to determine whether recalls were completed correctly, failed to decide on a timely basis whether recalls were made properly and did not document justifications for terminating recalls. “Taken together, GAO’s preliminary work suggests that the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market” (here is the new GAO report). Among the examples to be cited: thousands of ASR hip implants made by Johnson & Johnson’s DePuy unit, which needed to be replaced due to high failure rates.

The damning conclusions will be the topic of a hearing today by the US Senate Special Committee on Aging, which will hear testimony from GAO and FDA officials, patient advocates and various expects (you can watch a webcast here at 2 pm EST). “Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective,” Marcia Crosse, the GAO’s director of health careCrosse, will say in written testimony for the hearing.

The hearing, by the way, comes just two months after a study in the Archives of Internal Medicine found only a fraction of devices recalled by the FDA had been approved under the more stringent PMA process (read here). Of 113 devices recalled between 2005 and 2009, only 21 were approved through PMA, while 80 were cleared by the 510K process. The upshot: most devices recalled for life-threatening or very serious problems were originally cleared by the lower standard.

The hearing will include patient testimony. Katherine Korgaokar, who received the DePuy ASR prosthetic hip that was recently recalled in August 2010, will testify at her dismay over FDA procedures. She had to have the DePuy device replaced in a second surgery. And her patient witness statement contains an attachment which shows that her surgeon got $600,000 in consulting and other fees from DePuy.

“Prior to this incident, I thought that any medical device that was actually being put into people’s bodies had been extensively tested before it was released to the public. I had no idea that devices could be ‘fastracked’ by the FDA with little or no testing. I also assumed that the FDA had systems in place to monitor drugs and medical devices for potential defects so that prompt action could be taken if problems arose,” according to her testimony. “Apparently, this did not happen with the DePuy ASR.”

In separate testimony, William Maisel, Deputy Director for Science at the FDA’s Center for Devices and Radiological Health, will say device makers share some blame: “Industry also shares a responsibility for the success of the review process and safety of medical devices. Data show that some companies submit poor quality applications, ask to meet with us but then ignore our feedback, or conduct poor quality clinical studies. This leads to unnecessary delays, wastes time and money for both industry and FDA, and exposes patients to unnecessary risks,” according to his testimony.

He will add that the agency has initiated its own assessment of its review and recall procedures, and sought independent evaluation by the Institute of Medicine. Having received comments, the agency “intends to initiate 25 actions implementing 47 of the 55 recommendations, including development of new guidance and enhancement of staff training,” Maisel will testify. Among the steps to be taken will be to issue guidance on clinical study design; issue “Notice to Industry” letters to allow the FDA to more quickly inform stakeholders of new safety concerns, and strengthen collection and analysis of post-market information (read his testimony here).

In response, David Nexon, who is senior exec vp at the Advanced Medical Technology Association, or AdvaMed, trade group, will testify that the 510K has an “exemplary record” of protecting the public (here is the complete AdvaMed reply).

There will also be testimony from Diana Zuckerman, who heads the National Research Center for Women & Families (read here); Baker & Daniels attorney Ralph Hall, who represents device makers (read here); and Frederic Resnic, an interventional cardiologist with Brigham and Women’s Hospital and Harvard Medical School (read here).