The FDA warning letter has been around for more than a quarter century, and questions about their use and abuse crop up periodically. Perhaps it's time again to ask whether warning letters actually fulfill their purpose, but one gets the feeling that like the horseshoe crab, this is a species that is unresponsive to allegations of obsolescence.
Before we go off on warning letters, however, we should acknowledge that Congress is looking into legislation dealing with the medical device inspection imbroglio. But will that change anything about the warning letter debate?
No foul odor, no foul
The warning letter is the brainchild of the FDA of 1991, when David Kessler sat in the commissioner's office. The original idea was probably to create a little public shaming and to let others in industry know that their competition had some issues, all of which would compel a company to clean up their compliance systems ... or to keep those systems in order from the get-go.
The problem with the public shaming piece is that the mainstream media almost never cover a warning letter unless it addresses a hot-button issue such as surgical meshes, and those in industry know all too well that a warning letter might be mostly or entirely about documentation. Frankly, even we in the trade press don't cover warning letters much anymore, so device makers probably don't know about most of them unless they have an employee who keeps track of the FDA warning letter page, or they subscribe to Medical Device Daily.
One of the really interesting things about all this is that device makers sometimes are inclined to see a recent recipient of a warning letter in a fairly benign light. Part of the logic here seems to be that if you have not had a warning letter in a long time, you may be headed for one of those jumbo consent decrees, such as the $100 million headache the agency dropped on Abbott in 1999.
Conversely, a company that has received a recent warning letter might be seen as having one of the more effective compliance systems in the business, which one supposes is an implicit nod to the Hawthorne effect. That's a big deal if you're an original equipment manufacturer, and even more so if you're a contract manufacturer.
This might not rise to the level of a perverse incentive, but it at least torques the discussion somewhat. The net effect might be that it's too close to a wash for some companies to worry about warning letters, right?
Close-out or close enough?
We're all familiar with the warning letter close-out program, which was birthed by the agency shortly after Peggy Hamburg took the commissioner's job. It was touted as a method for removing the shroud of shame from a company's head. The problem with the close-out letter is that almost all the recent close-out letters are to companies regulated by the Center for Tobacco Products; in other words, companies that are newbies to the world of FDA regulation.
We might forgive our collective cynicism for thinking it's a rookie mistake to believe that a close-out letter is of any intrinsic value. In my imagination, device makers are watching the recipients of these tobacco center warning letters scurrying about in pursuit of a close-out letter and thinking, "are you sure you don't have better things to do with your time?"
After all, a web search for the term "FDA warning letter" returns few or no hits for products regulated by CTP in the first three pages on your favorite browser. Clearly the public relations value of a close-out letter does not exist even for these companies despite that nobody makes a cigarette that treats coronary artery stenosis.
No runs, no hits, no errors, no point So we've visited the presumed benefits of warning letters and found them lacking. Then we consider the lack of value of a close-out letter, which leads us to ask why the warning letter hasn't found the embrace of oblivion.
The easy answer is that the FDA has no intention of letting go of an instrument that suggests the agency still has teeth, even if a closer examination makes those choppers look like wooden dentures. There's always detention for imported devices and quarantine for domestic devices if there's a real problem, and it's not as if the agency's grab bag of enforcement tools ends there.
Beyond that, there's this question of whether untitled letters were any better. Better yet is to ask whether it makes sense to slap someone with a warning letter for failure to define terms such as "became aware of," but let's acknowledge something: If you don't want documentation hits in warning letters, you have to agree to an EU-style inspection of your manufacturing processes rather than an FDA-style inspection of your record-keeping practices. So pick your poison.
But all that leaves us right where we began, doesn't it? The FDA warning letter might not be very useful – assuming it's at all useful to anyone other than regulatory attorneys and consultants – but it's not going away, either, if only because of inertia. After all, what incentive does the FDA have to do away with the warning letter when it's one of the few public-facing manifestations of enforcement?