Medical Device Industry Skeptical FDA Training Initiative Will Do Much Good

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Medical device companies are telling us off the record that they are not particularly optimistic about the FDA’s much ballyhooed new reviewer training programs it unveiled last week.

“If it makes reviewers act more consistently it will be positive but I think the problem is deeper,” a small medical device shop told us this week. Their products are mostly Class I but last year they began a Class II review process.

“Our reviewer left the agency in the middle, and the new guy asked a whole bunch of new questions and even questioned some of the old questions again,” the CEO told us.

His situation is not atypical, according to John Smith, Partner at HoganLovells.  His firm has represented over 500 medical device companies navigating the FDA review process. And what he’s seen isn’t pretty.

“It’s well known in the medical device world that depending on which FDA reviewer is assigned, you may get dramatically different results,” John told us. Like our small medical device shop CEO’s experience, John has also seen the review process change completely when one reviewer leaves and is replaced mid-process.

John’s also seen too many situations where similar Class II products get completely different treatment during their review. “That inconsistency is tough for industry to deal with,” he adds.

“It’s not uncommon for a new member [of the FDA review team] to raise new questions or even go back and look at areas the device company thought were already addressed” by the outgoing reviewer, John says.

CDRH chief Jeffrey Shuren has sometimes downplayed the impact of FDA turnover on the review process, but he generally concedes that the agency needs more help here.

The FDA’s current training initiative is not making any hearts flutter with happiness in medical device land, but John says it is a positive at least in the sense that “the FDA is right to identify this as an issue where resources should be directed.”

For John and others, the impact of this training initiative won’t be clear for months and maybe years. “It sounds like a worthwhile initiative, but we’d like to see the results,” he diplomatically says.  “It’s easy to identify the problem, let’s see if the FDA addresses it.”

But former FDA reviewer Patrick Stone says reviewers will keep leaving unless the agency makes some fundamental changes. “They never praise reviewers or give any positive feedback, and that’s why most reviewers can only take it there for about five years.”

The Senate is also expected to hold hearings in the Fall that will look at how good, or bad, the FDA’s current device review process is and how effectively it balances patient safety with spurring product innovation.

Summer’s over. Back to work.

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