In June of 2008, January of 2009 and again in June 2009 the General Accounting Office issued reports on the FDA and its oversight of medical devices. The June 2009 report echoed findings from the earlier January report, put forth a recommendation regarding the agency's assessment of the resources needed to fulfill its mission respecting medical device oversight, but the 2008 report, entitled "Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments" made specific recommendations as to how the agency be operating in the regulation of devices.
This week, the agency took a step toward that end, and it has some communications implications for device manufacturers going forward as well as, perhaps, some marketing implications for existing devices. The agency announced that it was going to change the process for medical device committees, but the effect is really changing the way in which devices are approved.
The June and January 2009 GAO reports stated that there are two ways for Class III devices to be cleared for approval. One was the 510(k) process that allowed a device to demonstrate equivalence to another legally marketed device or through the more stringent pre-market approval (PMA) process. The latter requires that a manufacturer to demonstrate safety and efficacy. The GAO stated that in 1976 it was envisioned by Congress that all such devices would eventually go through the more stringent process, but that has not been the case and the recommendation was that FDA put forth a pathway for putting devices through the more stringent PMA process.
The FDA announcement this week does not put into place that kind of new process, but it did change the process for approval considerations at medical device advisory committees that at least seems a prelude to the bigger change. The release by the FDA said that the way that information is presented in meetings will change and couched the substantive change in the way that committees vote for approval. One side issue – committees will no longer vote by show of hands, they will use ballots. Who ever thought that was a good idea?
But more to the substance, the FDA used to present a unified point of view about the approvability of a device. Now they will present the range of opinion that resided with the FDA staff reviewers for the panel's consideration. And before, panels voted on the general approvability of a product after hearing the staff opinion, as opposed to specific issues of risk versus benefit. Now they will vote on risk versus benefit. It might be a disconcerting surprise to many consumers that the system was not set up this way in the first place, but there you are.
So what is the communications and marketing takeaway? First, from a communications point of view, it would appear that the character of these meetings is going to more closely reflect in character and in practice that of a drug approval. That means that for the future, device manufacturers would be well advised to observe recordings of some drug approval meetings, or at least attend some future ones, to understand the methods of presenting safety and risk information and addressing the concerns that will be expressed by FDA staff in their review. There are past meetings were there are some very good examples of this, and some where there are some good examples of how not to do this. I've worked with a lot of presenters going into such a meeting. It is good to learn the difference before you go into your meeting.
The marketing takeaway is this. If I were a device manufacturer who went through this kind of AdComm and I was competing against a device that had not, I would certainly find a way to communicate that the issue of safety and benefit was actually voted on for my device, while for others in a class, only approvability had been the subject of a vote. It might be considered a marketing advantage.
Lastly, one can only speculate that this kind of move is a prelude to the FDA's eventual embrace of the recommendations made by the GAO. It might be a good idea to begin preparing for that as well.
