October 3 2011
FDA Hearts Process
The FDA is killing people. That may sound a little harsh, but the Wall Street Journal today has a piece on how thousands of people who could have benefited from an aortic valve device have died because the FDA is slow to approve it:
Scott Gottlieb, physician, fellow at the American Enterprise Institute, and former deputy commissioner of the FDA, notes in the piece that, as people age, the main valve carrying blood from the heart becomes brittle:
Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year end-more than four years after it first hit the market in Europe.
This is an all too familiar story, the FDA impeding useful innovations in the U.S. Entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. When clinical studies get started, the FDA is asking for longer and larger trials that increasingly mirror hurdles proposed for new drugs.
The makers of these devices have a solution: go abroad. China, India, and Brazil are benefitting from these companies that find doing business in the U.S. is no longer feasible. You can abuse these firms as "Benedict Arnold Companies" all you want. But they have no alternative if they are to continue being innovative and creating profits for their investors. I prefer to call them "Charles Darwin Companies" because they are simply trying to survive.
The consequences of sending these companies abroad are enormous, and not just for people who have heart trouble:
Many emerging-market countries including China, India and Brazil have enacted "country of origin" rules. These laws require a marketed device to be made in the same country where it received regulatory approval. Companies know they'll get European approval long before they get the FDA's nod. So if they want to market their devices in these emerging markets, they need to make sure manufacturing facilities are also located in the European Union.
Not surprisingly, U.S. investment in medical devices is falling. According to data from PricewaterhouseCoopers and the National Venture Capital Association, the number of newly started, venture-backed medical-device companies fell to 60 in 2010 from 118 in 2008. The magnitude of these declines dwarfs those seen in other entrepreneurial sectors. It can't reasonably be ascribed to the struggling economy alone.
So the good news is that the FDA is streamlining its process and this problem will soon be remedied? Not a bit. The FDA is demanding more trials and holding up the process even more. That is how bureaucrats think. If you like this, you are going to love Obamacare, which puts bureaucrats in charge of an even larger chunk of our health system.