Liberating Drugs
This is Alex Tabbarok at Marginal Revolution:
I agree but I would go further: Any drug or medical device introduced into say the EU, Japan, Canada or Australia ought to be automatically approved in the United States within 90 days. Such a procedure would reduce delay, eliminate needless duplication and cut costs.
Think about it this way: Europeans don’t regard the FDA as the best or final arbiter of safety and efficacy so why should we?
Senate-passed FDA reform bill will do just that, thanks to an amendment by Rand Paul.
Great idea.
I’ve talked to industry insiders who claim the FDA doesn’t really trust the EU to be thorough enough to satisfy American’s heightened desire for safety. However, American’s need to be educated that no drug is perfectly safe. Furthermore, sometimes a drug’s benefits outweighs its harm. Rather than demanding perfect safety, maybe the FDA should demand complete disclosure and post-market monitoring. Americans could be warned that until a drug has a track record dating back several years, the risks will not be fully known. The bottom line is: let Americans have quicker access to new drugs; but make them aware the full extent of the risk is unknown.
speeding up bureaucracy is not a bad idea.
Brilliant idea.
I like it.