In the ongoing debate over safety and efficacy involving the U.S. Food and Drug Administration, a new recommendation comes from a knowledgeable source who suggests FDA needs a thorough revamp.
In an op-ed piece in the Wall Street Journal, Andrew Von Eschenbach, commissioner of the FDA from 2006 to 2009, argues that in order to help the U.S. biomedical industry retain its global lead, the FDA needs to approve products if they are safe and test for efficacy in post-market studies.
Of course, Congress, who Von Eschenbach exhorts should make this happen, will never allow it. Throngs of consumer advocacy groups will ensure that such a proposal dies a quick death.
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But that is not the only reason this idea is doomed. The medical device industry may not want this to happen either.
Why? Because the concept of federal preemption — under which device manufacturers making expensive PMA devices have enjoyed relative protection from product liability lawsuits — will thereafter most likely come under scrutiny. And device manufacturers will become more vulnerable.
Here’s a recap of the status of federal preemption courtesy of Robert Klepinski, a regulatory expert at the law firm Fredrikson Byron: Currently, federal preemption — the idea that once a product has been approved by the FDA, lawsuits against the product’s maker cannot be brought in state courts — covers devices approved under a PMA, or premarket approval process. The exception being that the manufacturer violated good manufacturing practices. Drugs don’t enjoy federal preemption. Neither do products approved using the 510(k) regulatory pathway, Klepinski explained.
Now, this process will have to be changed if the FDA begins to approve devices solely on the basis of safety relegating efficacy to post-market studies. A whole new legal regime would have to be developed to manage the issue of product liability on complex medical devices because the argument that the FDA cleared it after a rigorous process and so the product is safe, will no longer have any weight.
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My guess is that’s a headache that already-taxed device makers would rather not deal with.