FDA Reverses Course on Melafind

Remember that a couple of months ago I wrote a piece about FDA overregulation, applied to the particular case of Melafind, a handheld computer vision system intended to help dermatologists decide which suspicious skin lesions should be biopsied for potential melanoma a system for assessing. The FDA’s original response to Melafind had been to deem it  “not approvable,” saying that MelaFind “puts the health of the public at risk.”

In my piece I analyzed why the FDA had unreasonable and contradictory expectations for Melafind. I then testified before a Congressional subcommittee on the subject.

Well, the FDA has surprisingly changed its mind. From the WSJ today:

Doctors in the coming months are likely to have a new tool to diagnose the deadly skin cancer melanoma, after the Food and Drug Administration reversed its earlier decision and said the MelaFind device was “approvable,” pending some final negotiations.

The FDA cleared the path for approval in a letter it sent to Mela Sciences Inc. Thursday night. The letter hasn’t previously been disclosed.

More to follow.

Does the FDA Impede Innovation? A Case Study

I have a new policy brief from PPI entitled “How the FDA Impedes Innovation: A Case Study in Overregulation”.  Here’s the intro:

As the key gatekeeper for pharmaceutical and device innovation, the Food and Drug Administration (FDA) has a tough job. If it is too lenient, it will allow the sale of drugs and medical technology that could harm vulnerable Americans. Too tight, and the U.S. is being deprived of key innovations that could cut costs, increase health, and create jobs.

With this in mind, this paper addresses the question: Is the FDA unintentionally choking off cost-saving medical innovation? First, I discuss the difficulty of assessing whether the FDA is under-regulating or overregulating new drugs and devices, given the desire for safety. I then show how the FDA is clearly applying “too-high” standards in the case of one noninvasive device currently under consideration—MelaFind, a handheld computer vision system intended to help dermatologists decide which suspicious skin lesions should be biopsied for potential melanoma, a life-threatening skin cancer. I then draw analogies to development of the early cell phones and personal computers.

The bottom line of the policy brief:

 If the FDA fails to approve MelaFind, it would be the equivalent of rejecting the first cell phone on the grounds that callers might mishear important messages.

Take a look.

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