Day 2 of the Third Annual Risk Management and Drug Safety Summit focused on the future from a policy perspective -- and why.
A few points to share and consider:
After the 65 presentations made at the FDA's public meeting and over 2000 docket submissions, it's becoming increasingly clear that not only is the agency's REMS initiative confusing to industry and stakeholders -- but that the problem is, in many ways, one of the FDA's own making.
Not that the there's anything wrong with the REMS concept, to contrary, the recent Avandia decision (and, notably, Tysabri) shows the value of a program that provides avenues for both approving and maintaining products with high risk profiles on the market. The problem is that the excesses of the post-Vioxx inquisition have inured many -- specifically practicing physicians -- to any kind of safety warnings.
When important safety warnings become ambient noise, we're facing a dangerous public health situation.
Consider the rash of black box warnings proliferated by the agency since the recall of Vioxx. It's the Precautionary Principle come home to roost. Despite the best intentions, early safety signal communications has resulted in a rash of negative unintended consequences: tabloid media reporting, patients scared into non-compliance, labels being increasingly "lawyered-up," and ever-more defensive medical practices that add costs to our already over-burdened healthcare system and birth ever-more (and more obnoxious) 1-800 ambulance-chaser ads. At a certain point, prescribers just stop listening. And that's not good.
Someone raised the issue of REMS and federal preemption. The laughter took a few minutes to subside. Bad decisions have negative unintended consequences. The implications of Wyeth v. Levine will be with us for years to come.
A related issue is that of product knowledge. What is the real level of understanding physicians have about the products they prescribe -- especially since they are spending less and less time with pharmacy field staff (often by politically-correct dictate).
Isn't it time that sales reps begin to "detail the label" to their physician audience? That would be a real public health service -- and also has positive marketing potential. A solid double play.
And perhaps it's time for the FDA to measure how the New Labeling Rule (not so new anymore) has impacted prescriber understanding. Such a study would be a whole lot more useful to protecting and promoting the public health than yet another study on the viewing public's understanding of fair balance and adequate provision. (And maybe its time for industry to step up to the plate and rewrite their existing labels in the new format.
Relative to PDUFA V reauthorization, it's going to be a tough slog for the FDA to ask for new things when it still has much to deliver on from PDUF IV. And that certainly includes many risk management issues, REMS included.
This becomes even more interesting when you consider the likelihood of different members of Congress wielding the gavel on some committees pretty crucial to the reauthorization process. One issue raised, relative to reauthorization, is the need for the FDA to clarify the when, where and how of the OSE in the review process.
The conference ended on a positive and thoughtful note. Rather than a laser beam focus on REMS, perhaps what is required (from both regulator and regulated) is a broader focus on the appropriate spirit of risk management -- of which REMS is only a piece.
Perspective. It's a wonderful thing.
