Hyperventilating about the FDA

Eli,

Thanks for the gruesome baby pics. What next? Sending me pics of a 16 car pile up?

I made three points:

1) Government regulation is not necessarily required for product safety to improve.
2) Regulation should be subject to questions about its efficacy.
3) False negatives can lead to poor outcomes.

Although I didn't make this point, it is equally true. If you delay a life-saving drug for years in order to do further testing, by definition you deny a life-saving drug to patients. At least for those patients, that is a negative consequence.

Bill.