When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011

While FDA and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has acknowledged it is facing real problems with staff turnover and tight funding. Both of these issues are leading to inconsistent reviews and, yes, some degree of incompetency—because many of its new reviewers are recent college grads with no relevant work experience.

December 19, 2011

2 Min Read
When Reason Meets the Absurd: A Quick Look at FDA and CDRH in 2011

FDA logoWhile FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has acknowledged it is facing real problems with staff turnover and tight funding. Both of these issues are leading to inconsistent reviews in the CDRH Office of Device Evaulations and, yes, some degree of incompetency—because many of its new reviewers are recent college grads with no relevant work experience.

But many of the decisions the agency makes are fair and rational. Sure, it doesn't help when, for instance, Jeffrey Shuren, MD, blames most of 510(k) clearance delays on the industry, when high CDRH staff turnover is at least part of the reason. But it's hard, for instance, to argue against the use of computational modeling, to beef up regulatory science. And, of course, the agency's reliance on statistics to justify its reviews does make sense. And it is a good idea to require manufacturers to show equivalence in safety and efficacy for products that represent incremental improvements to existing products. It is also a sound idea to opt for randomized clinical data when possible.

But sometimes the push for randomized trials is not always reasonable. At times, the agency itself has trouble with risk–benefit analysis. I recently spoke with a medical device entrepreneur who provided an example of this. His company had developed an implantable device that was approved and commercialized in Europe. "We went to the FDA with a trial design and they came back and said 'it has to be randomized,'” he explained. "They are invoking this randomization in absurd situations."

In this example, FDA told the manufacturer that the clinical trial has to have two groups. In one, the device is implanted to assess its effectiveness. In other—the control group, the device is implanted but not switched on. "Which patient in their right mind would subject themselves to be implanted and not have the device turned on?" the entrepreneur asks. This is where FDA's logic become irrational: where a formulaic notion (randomization) that makes sense on paper doesn't make sense in a specific instance. 

"Randomization is a great idea," the entrepreneur acknowledged. "It takes the placebo effect out; it takes the biases out of the trial. But randomization cannot be done when surgery is involved. Or when the patient knows that he is getting a dud."

—Brian Buntz

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