GAO Recommends Increased FDA Oversight of Medical Device Recalls
On June 14, 2011, the U.S. Government Accountability Office (GAO) released a new report on the U.S. Food and Drug Administration’s (FDA) oversight of medical device recalls. The report determined that the FDA’s current system for reviewing medical device recalls does not satisfactorily guarantee the removal of unsafe medical devices from the market.
In this report, the GAO discussed how the FDA uses information derived from medical device recalls to aid its oversight. The GAO analyzed data from a sample of medical devices that were recalled between 2005 and 2009. The report identified several deficiencies in the FDA’s current system and recommended that the FDA 1) develop enhanced procedures and criteria for assessing the effectiveness of recalls, 2) document the agency’s basis for terminating individual recalls, and 3) routinely assess information on device recalls. The U.S. Department of Health and Human Services (HHS) agreed with the GAO’s recommendations.
Even though medical device recalls are typically initiated by the firm that manufactured the device, the FDA is responsible for overseeing the implementation of a recall. Over 3,500 medical device recalls were initiated over the five-year period under scrutiny in the report. In addition to its unclear procedures for overseeing recalls, the report indicated that the FDA lacks established criteria for assessing whether firms corrected or removed an appropriate number of devices from the market. Without clear guidance or criteria for recall termination, the FDA frequently exceeded its own prescribed timeframe when making decisions and failed to provide documentation as to how it reached those termination decisions. As a result of the FDA’s vague regulations and processes, FDA officials examining similar recall situations often reached opposite conclusions on the efficacy of a firm’s recall efforts.
The GAO report also found that the FDA does not regularly analyze its own recall data to identify recurring trends or problems with medical devices. This is a “miss[ed] opportunity to use recall data to proactively identify and address the risks presented by unsafe devices,” the GAO report stated. Senators Chuck Grassley of Iowa and Herb Kohl of Wisconsin are strongly pushing for the FDA to establish periodic reviews of medical device recall data. Senator Grassley explained that “patients would be better served if the FDA took a thorough approach to post-market surveillance of medical devices” because early identification of dangerous devices would “establish greater accountability for patients.”
The FDA’s ability to analyze existing data for clues about potentially hazardous medical devices is particularly important in light of the FDA’s new Medical Device Innovation Initiative. As we reported earlier this year, the FDA launched an accelerated review program for “new, breakthrough medical devices.” Installing review procedures of recall data provides the FDA with an opportunity to regain leverage in the scientific community. Understanding where older devices were inadequate or flawed places the Agency in a better position to make better decisions about future medical devices. This review process can also help keep the FDA from falling too far behind the rapidly evolving scientific community.
The GAO’s report comes less than a month after the GAO issued a report urging the FDA to make changes to its seafood oversight program, as we reported here. Together, these reports highlight significant weaknesses in the FDA’s regulatory scheme, which have direct implications on public safety and health.
Although Americans continue to demand more improvement from the FDA, it is less clear whether the Agency can implement any real changes. As we reported here and here, the significant decrease in the FDA’s funding may impede the Agency’s ability to institute change.
Fuerst Ittleman, PL will continue to monitor the developments in the FDA’s medical device oversight program. For more information, contact us at contact@fidjlaw.com.