Accelerated; Language and the New FDA

October 19, 2017 – 8:42 AM | By Mark McCarty | No comments yet
FDA; sucked into a regulatory wormhole!

FDA; sucked into a regulatory wormhole!

We’ve all been witness to a variety of predicaments in terms of the FDA’s premarket review of biologics, drugs and devices, but while controversies abound, there’s also this nagging question of how words color perception. It’s an important consideration, one that legislators and government agency employees might want to carefully think through before committing things to print.

A good example is the term “accelerated approval.” This is a term the FDA has itself used, so its understandable when the agency’s critics blast the FDA for its seemingly hasty review process for these products. I would hasten to point out, however, that the FDA is not the only author of this kind of rhetoric.

When fast isn’t fast enough

One of the problems with the “accelerated approval” discussion is that the agency has several programs for accelerated approval and priority review. After all, the Food and Drug Administration Modernization Act (FDAMA) of 1997 gave us fast-track review for drugs. Ten years later, the Food and Drug Administration Amendments Act (FDAAA) gave us the priority review voucher program for drugs. We have a priority review program, so to speak, for breakthrough medical devices, and some have characterized the 510(k) process as a fast-track program, too.

How well are these programs working? It depends on whom one asks. The agency recently approved the use of Opdivo (nivolumab) for second-line treatment of hepatocellular carcinoma, not exactly a trifling health issue. Will this work out in the end?

Only time will tell, but patients aren’t exactly waiting in line to see how it would have worked without accelerated approval. After all, the five-year mortality for all patients with this condition is about 50 percent. That number plummets to 11 percent for locally metastatic disease by some estimates. Anyone care to go on the record as telling these patients that it’s their tough luck, and they’ll just have to wait their turn?

There are plenty of other examples of drugs and devices that went through a premarket examination at a gazillion times the speed of light, but what I never hear from critics is the number of hours the FDA staff put into that premarket review. Maybe the term “priority” is really where a lot of the action is, although it is legitimate to note that the agency is requiring less data on the front end of the product life cycle and more data on the back end.

Still, if a patient has been made aware of the attendant hazards, who are the FDA’s critics to say this product’s entry to market was too hasty? I suspect most people stuck in a hospital bed would say, “it’s my life and I’ll do with it what I damn well please.”

Slower won’t do in America

Some complain that some of these rapidly reviewed items are experimental, but aren’t all drugs and devices really experimental in the end? Granted the argument is easier to make for devices, given how iterative they are, but who really wants all the side effects and other problems associated with a lot of reasonably effective drugs and devices that went through the typical, more leisurely pace of premarket review?

And let’s not forget that American patients want the best, and by God, we want it now. We in the U.S. are justly reputed to live in the world’s most feverishly high-risk/high-reward culture. That’s why there are so many fast cars and so many workaholics in the U.S. This is who we are, folks, and that has a lot to do with the culture of “accelerated approval” on Capitol Hill and at the FDA.

But back to words and meanings. If you use the term “accelerated approval,” you are pretty much setting yourself up for this rhetorical crucifixion, however absurd some of it might be. It doesn’t matter to the naysayers that their latest bogeyman, FDA commissioner Scott Gottlieb, has been at the agency only five months. He still takes the blame for a drug approval rate deemed “staggering” by breathless scribblers who only belatedly acknowledge that this blistering pace was already underway when Gottlieb took the job. So some of the critics are a bit unhinged and hence it won’t matter how you exercise (or not) artistic license in many instances.

Still, the term “accelerated approval” is a big, fat target, and is a term that ought to be avoided, particularly when FDA employees make a point of continually saying that standards of premarket review have not been compromised by these programs. It just sends too many mixed signals, and even some of the most vocal supporters of the 21st Century Cures Act will have few kind things to say about “faster cures” when the inevitable problem arises.

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