January 24th, 2010
Is the FDA too Lax?
Richard A. Lange, MD, MBA
A recent review reports that cardiovascular devices are not subjected to nearly the same level of scrutiny as drugs, raising concern about the true safety and efficacy of approved new technologies.
Do you think this has placed patients at risk, or is it a welcome difference from the lengthy and onerous approval process that delays the implementation of potentially highly effective treatments?
7 Responses to “Is the FDA too Lax?”
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Drugs and devices
Devices have the same potential for benefit and harm as most drugs — hard to imagine why it is not necessary for them to undergo the same scrutiny. And what surprised me about the JAMA article was not just that there were few studies, but that the methodological flaws in the studies were so abundant. It just seemed not to matter in the approval process.
There is clearly a need to strengthen the foundation of the existing premarket review process and modernize device regulation. Over the past couple of years, the CDRH at the FDA had taken appropriate steps to move in the right direction. Unfortunately, it appears that the plans for medical device regulation were scuppered for political expediency with the device industry raising the bogey of strict regulation hindering innovation. I have heard claims about medical device and technology “brain drain” generated principally via nonscientific surveys, but not seen any persuasive evidence to back up this claim. Has anyone?
Sanjay. Based on your experience, we’d benefit from your perspective about how “plans for medical device regulation were scuppered.”
At least one of the issues is determining if a device change results in a “new” device (which requires extensive premarket testing) or an “equivalent” device that is approved without randomized clinical trials (RCT). For example, when an approved automatic external defibrillator is built with a computer chip from a different manufacturer, is it an “equivalent” device or is it significantly changed or modified to the extent that its safety or effectiveness could be affected (and subjected to RCT)?
Richard, your example regarding the automatic external defibrillator with a new chip from a different manufacturer would qualify for a “substantially equivalent” approval pathway provided it passes the quality control standard on bench testing. The shorter approval pathway requires companies to show a product is “substantially equivalent” to one already on the market and typically does not require human testing. The problem is that it is too widely used and sometimes allows unsafe products to be marketed.
In September 2009, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making was established by the FDA’s CDRH to address critical challenges facing the center regarding approval of medical devices, especially the Class II devices approved via the 510(k) program that requires “substantial equivalence” to a predicate device. The preliminary reports from the Working Group were released in August 2010 for public comment with the plan to implement the recommendations in early 2011. However, in January 2011, immediately following the resignation of Joshua Sharfstein – deputy commissioner of the FDA who led efforts at the FDA to toughen regulation of the medical device industry, the FDA announced it would be holding off on implementing the most substantial recommendations until an external panel convened by the IOM issues its recommendations in July 2011. To what degree did politics play a role in Dr. Sharfstein’s stepping down from his post and the FDA’s announcement to hold off on implementing the Working Group’s recommendations is anybody’s guess. I am still hoping that the IOM and the Working Group’s recommendations will balance the FDA’s dual goals of promoting and protecting public health.
Those of you who are interested in this subject will find the following links informative.
http://blogs.nature.com/nm/spoonful/2011/01/fda_balks_on_medical_device_re_1.html
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239449.pdf
http://www.nytimes.com/2011/04/13/health/13implant.html
Sanjay:
A recent FDA panel was convened to discuss automatic external defibrillators (AEDs) which became available for public use after gaining approval through the 510K “substantially equivalent” process rather than premarket analysis (PMA) process. Reports of 1000’s of device failures have subsequentially surfaced, with mot related to changes in the manufactured components. The 510K process doesn’t address this. How would you solve this?
Because AED technology is constantly evolving, and because most iterations are not major “tweaks” that cannot be properly evaluated via bench or field testing, and because defibrillation is relatively rare, requiring PMA (even though AED is classified as a Class III device) might be overly restrictive and cumbersome and in some cases it may even run counter to the spirit of promoting public health espoused by the “least burdensome pathway” by slowing the pace of improved technology reaching the marketplace.
I would start with strengthening the “quality control” process such as timely review of AED manufacturer procedures, perform random preapproval inspections, review any changes in manufacturing facilities, require manufacturers to annually report any changes in their manufacturing process or design, conduct oversight of premarket animal studies, strengthen post-market surveillance (perhaps the best way to capture information about efficacy and safety given the low frequency of defibrillation), and implement timely recall once problems have been identified.
Perhaps, an independent safety/surveillance division within the CDRH with authority to enforce regulatory requirements would facilitate this process.
Very interesting, I agree with the commentaries and a just want to add, one lope hole you must address is the prevalent strategy used for almost every company. They usually choose voluntary recalls so their devices can continue to serve as models for future products. If the device had been taken off the market by the FDA then this 510k substantially equivalent Law works against them.