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.


  1. Nice paper, great example of Melafind. It’s obvious that the FDA has been captured by the regulated just like any other govt regulatory agency, as the criteria they’re criticizing it with are ridiculous. It’s clear that the “expert dermatologists” are simply afraid that they will have work taken away from them by this computer vision system. Yet another example of how the purpose of the FDA and other govt agencies is to keep out competition more than anything else.

  2. Michael Mandel of the Progressive Policy Institute will tell Congress that the FDA should look for devices like these early computers that have the potential to transform healthcare.

  3. You really make it seem really easy with your presentation but I in finding this matter to be really one thing which I feel I would never understand. It sort of feels too complicated and very vast for me. I am looking ahead for your subsequent post, I’ll attempt to get the dangle of it!

  4. I love the valuable info you supply in your posts. To be honest I am not sure I can agree with you.


  1. […] Does the FDA Impede Innovation? A Case Study ( […]

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s


%d bloggers like this: