Wednesday, January 19, 2011
Yesterday, President Obama signed an executive order making it the "operating principle of our government" that regulation "strike the right balance" between its protective function and stifling economic activity, immediately inviting the question: "Why does the federal government need to be ordered to do that?"
Be that as it may, today at 12:15 we will get an immediate test of President Obama's sincerity. Per an email from a Wall Street device analyst, the Food and Drug Administration has scheduled a "media briefing" to issue "a list of 510(k) pre-market program reforms that it intends to implement in the near-term." The 510(k) program is the principle means by which the FDA clears medical devices to be sold in the United States. Last year the FDA announced its intention to increase the testing burden on new device clearances, which in turn will increase the cost of clearance and the time to market (itself a cost). While this might be good news for companies with established products (because there would be a new barrier to competition), the proposed "reform" promised to increase the financial return "hurdle" required for any new medical device to attract capital. In short, the FDA's proposals would entrench previously cleared products and keep new products that are approved for sale in such libertarian paradises as France and Germany from use in American patients, sometimes for years and in other cases forever.
It will be interesting to see whether the FDA read President Obama's order.
The first thing O did as POTUS was sign executive orders to close Guantanamo. Also signed an executive order not allowing abortion to have any part in Obamacare. Any questions?
Waiting for the followup post. It is possible (but not likely) that having this briefing so close to the executive order would indicate some sort of cooperation between the FDA and the President. It would be "throwing a bone" to have a nice puffy briefing about how lovey-dovey the administration is going to behave to our high-tech medical device field, and a horrible gaffe if the executive order were to be followed by a crackdown/extortion scheme. Not to mention the amount of negative press the Prez would get from the radio talk shows.
Not that I would rule out the gaffe...