As we've heard multiple times before, the Food and Drug Administration (FDA) really takes a beating from medtech manufacturers and patient advocacy groups because of the long medical device approval times in the US the fear is that the US will fall behind in terms of innovation, with the most advanced devices entering other markets, such as Europe, years before they become available in the US.
But how much blame does the FDA really deserve? The FDA's responsibilities are pretty overwhelming they have to ensure the safety of every medical product before and after it is approved, regardless of whether or not it was manufactured in the US. And this article states that more than eight million shipments of medical products arrive at US ports every year. The organization has definitely taken the blame when approved devices haven't performed as planned take the recent scandal with metal-on-metal hip implants, for example. So how can the FDA ensure the safety of US citizens while satisfying the need for innovative technology.
The answer might be simple in principle: more funding. This article in the Boston Globe discusses how the FDA is chronically underfunded, which makes it difficult for the organization to manage all of its responsibilities. Furthermore, staff turnover continues to be a problem, which lengthens the process because the new hire will need to spend time getting up to speed before product evaluations can continue.
Nonetheless, the FDA has acknowledged the long approval times in its strategic priorities press release for 2012 and vowed (albeit somewhat vaguely) to better manage the approval process. This promise has been reinforced by the recent agreement between the FDA and the medical device industry on user fees the industry agreed to pay $595 million in user fees over five years and in return the FDA agreed to set certain performance goals, including reducing overall approval times.
Maybe this whole issue would be solved if the FDA had more funding but then again, it would be hard to find any group that would argue that they don't need more funding!