Several months ago I made an offhand suggestion in this communiqué that medical device regulatory approvals could be greatly eased without compromising patient safety simply by having FDA require proof of safety but allowing clinicians to establish product efficacy over time. This would be a combined regulatory and market-based approach. I think the scheme could actually be made to work, but the howls of many patient advocates would be deafening indeed.

     Now, I dare not claim that they appropriated my idea -- after all, ideas are everywhere and untrackable -- but Michele Boldrin and S. Joshua Swamidass of Washington University published an opinion piece in the Wall Street Journal on July 25 touting a rather similar notion. I've quoted the essence of their idea from the article:

"We can reduce the cost of the drug companies' bet by returning the FDA to its earlier mission of ensuring safety and leaving proof of efficacy for post-approval studies and surveillance. It is ensuring the efficacy -- not the safety -- of drugs that is the most expensive, time-consuming and difficult. All the usual mechanisms of ensuring the safety of drugs would remain firmly in place. In exchange for this simplification, companies would sell medications at a regulated price equal to total economic cost until proven effective, after which the FDA would allow the medications to be sold at market prices. In this way, companies would face strong incentives to conduct or fund appropriate efficacy studies."

     I recommend the article to your attention. Its title is "A New Bargain for Drug Approvals". You can read it online with a WSJ online subscription.

     Interesting idea? You bet. Could it work? Just like mine, I think so. Does it have any chance of adoption? Unlikely, but you decide!