July 17, 2017

FDA House Legislation Would Relax Reporting of Medical Device Malfunctions

On July 12, 2017, the U.S. House of Representatives passed a bill to reauthorize four of the U.S. Food and Drug Administration’s user fees and to change various drug and device testing rules. H.R. 2430 – the FDA Reauthorization Act of 2017 – was passed with strong levels of bipartisan support.

The five-year user fee agreements were last passed in 2012 and are set to expire on September 30, 2017. The measure has been sent to the Senate for further consideration before September 30. 

The bill would reauthorize four programs that allow the FDA to collect fees from various medical device manufacturers to fund its premarket review process, fast-tracks certain drug and device trials, and increases generic drug competition.

The bill would also increase the time medical device companies have to report malfunctions of certain higher-risk products. This change, outlined in a statement included by reference in the bill, would allow companies 90 days to report certain product malfunctions, rather than the 30-day deadline currently in place. While cases involving patient complications, injuries or deaths would still have to be promptly reported within the 30-day timeframe, companies would otherwise have three months to file reports on devices that do not work properly, including regarding malfunctions that could potentially injure the user. 

The bill would also allow companies to provide quarterly summaries of previously reported product malfunctions, rather than filing detailed reports on each case. However, this type of summary reporting would only be allowed for malfunction incidents that are already well-understood and familiar to the FDA. According to the Star Tribune, new types of malfunction incidents not previously reported to the FDA would still need to be reported to the agency as an individual report.

Critics of the legislation have expressed concerns that the proposed policy would withhold important medical information about device problems for an additional 60 days and could otherwise limit access to public information. They note that underreporting of faulty devices is already widespread, as it can take months or even years for the FDA to learn of risks or dangers involving various devices. Consumer advocate groups point to instances in which initial reports of device malfunctions did not involve any injuries, but evidence of patient harm later emerged. Critics also worry that the new bill will make it harder to spot developing trends in device problems.

However, proponents of the bill say it will allow the FDA to better focus its resources on more serious events. According to the New York Times, the FDA currently receives about 65,000 reports of “adverse events” per month. Those in favor of the bill say that the current system of reporting all product malfunctions for already-known issues under a 30-day timeframe is repetitive and burdensome and does little to help doctors and patients. 

Proponents also note that individual reporting will become less important in the future, as the FDA begins to utilize a new system that mines electronic records to automatically detect troubling patterns sooner. However, this system will not be operational for several years.

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