FDA is the arbiter of safety and efficacy, not value

Now I know that the FDA is, like other federal agencies, under current scrutiny to justify its existence as more than a federal rubber stamp for industry.  I know that there is certainly room for improvement in the agency’s ability to effectively ensure the introduction of safe, effective products in the market.  But let’s think for a moment about where the limit of that federal intervention should be.  Perhaps the FDA should rigorously evaluate each and every product on a de novo basis, even if the only difference is the color of the device or the particular font used in the product packaging.  Perhaps the FDA should always ensure a minimum time necessary to complete each product review (say, ten years).  Perhaps the FDA should set the prices for products based on some clinically-driven product valuation algorithm.  Of course, I am being absurd.

But, today I read in NYT today ("F.D.A. Criticized on Device Approvals") about the GAO report on recommendations that the FDA fulfill its commitment to improve the process it uses to approve complex medical devices.  No problem there.  The issue relates to the use of 510(k) approval of medical devices, which allows new devices to be deemed "substantially equivalent" to already approved devices and therefore considered sufficiently tested.  Again, as long as the FDA is the arbiter of this, is there really any legitimate argument with this?  However, the crux of the GAO report on this is that legislation in 1990 stipulated that the FDA write rules setting specific deadlines for when all Class III devices must go through rigorous testing before being approved, but the FDA as yet has not done so.

OK, here comes the absurdity.  In response to this, Dr. Peter Bach, says:

“So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, ‘Look, it’s a car just like the Model T,’ ” said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center and a former senior adviser to Medicare and Medicaid. “Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without any necessary actual improvement in outcomes.”

I have to believe his quote is taken out of context.  I have to believe he’s much better at pulmonology than federal policy.  Does he really advocate that the FDA approve products based not only on safety and efficacy, but also on the value of products in the marketplace? Implicit in this is the suggestion that the company is dictating to the FDA that the product is "just like the Model T".  Implicit in this is the assumption that the FDA should determine not just whether the product is at least as good as the previously approved Model T, but also whether it is better and MOREOVER, whether that product will drive up costs.

I am not a physician, but if I were, I would take affront at the notion that I can be convinced that a Ferrari is necessary, when the Model T is the best prescription.



Leave a Reply