As a society we value and sometimes even need activist organisations to represent the interest of the common man in one cause or another. To take a stand against fight evil capitalists and their dependent legalists for example. Maybe that’s going a bit far, but you get the point. This goes for the medical device world too, and indeed the consumer’s rights group, Consumer Reports has shot from the hip on medical device regulations before as reported on our own pages. Now its policy and advocacy arm, Consumers Union is calling attention to what it is calling a “dangerous medical device loophole” that apparently “puts patients at risk”, by printing a full-page ad in Politico today. The ad is timed to coincide with the Senate’s vote on a bill this week to re-authorise the statute governing medical device oversight.
What it all revolves around is the unearthing by Consumers Union of a legal loophole under which device makers cannot be required by FDA to prove they have addressed design flaws in a recalled predicate product when they want to sell a new device based on it.
What is less clear is why any device maker, keen to keep its investor community intact and happy, would want to launch a product with a known device flaw. So is the complaint a red-herring, a stalking horse for bigger issues or a key point on which Consumers Union can win in order to strengthen its arm?
First of all, let’s examine the starting points of the various parties. The medical device industry’s position is always likely to err on the side of less regulation, so it’s perhaps unsurprising to hear it say it believes FDA already has the necessary power. Given that FDA’s position is usually that it wants more regulation, it’s equally unsurprising to hear that esteemed organ saying it does not have enough power in this particular regard.
So who’s right?
Well, Consumers Union quickly makes that something of a moot point by turning its guns onto the 510(k) process itself, an issue far bigger than the loophole that started the piece. The press release from Consumers Union damns the 510(k) process with phrases such as “fast track” and “substantially equivalent” (the inverted commas clearly being intended to raise questioning eyebrows).
So the argument goes that the demonstration of substantial equivalence only works if the product to which it is substantially equivalent is safe and free from flaws. Consequently when an entire class of device is found to be potentially flawed, then device makers should have to address those flaws before gaining approval. In the case given, the well-known vaginal mesh debacle, this has clearly not been the case as new devices have been approved subsequent to problems being identified.
So, let’s examine that for a minute. Device maker ABC Inc observes things going badly wrong with product X so decides to launch its own version which it knows has had zero work done on it to address the problem? Is that really going to happen in a world where lawsuits have all-to0-recently cost millions?
Maybe that gut response is a bit too simplistic. Maybe there are situations in which companies are too far down the tracks to pull out, or even believe they’ve fixed it with their own brilliant solution, or believe that the flaws are not intrinsic but product related/specific. All those scenarios could happen, but again consider whether a company, having identified a flaw in a predicate product, is ever going to risk launching an analogue?
It’s a tricky debate, but even the most one-eyed observer must accept that these issues are rarely black and white and particularly that they are not often blessed with the hindsight that says “of course it was stupid to clear subsequent product X or even Y.”
So can we expect the usual responses? FDA assurances about safety and medical device manufacturer industry bodies claiming the ad to be an overreaction to one facet of what is actually the most tightly regulated medical device market in the world?
Probably. Or they might choose to ignore it.
Consumers Union comments
“It’s time to close this absurd loophole and give the FDA the power it needs to protect patients,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “But so far, the politically powerful medical device lobby has blocked this common sense reform. Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients.”
“Medical device makers have misled Congress that this reform isn’t necessary, but the evidence is clear that the FDA doesn’t have the power it needs to protect patients,” said McGiffert. “It’s time to use some common sense and close this indefensible loophole in the law.”
Source: Consumers Union, PR Newswire