An interesting article about the costs of regulation by Eliezer Yudkowsky It links to the benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade. Note three things about the foregoing passage. (1) The comparison is between the FDA and the foreign systems of drug control. (2) The relative benefits of the FDA are expressed in number of casualties, whereas the relative costs are in number of lives. (3) In addressing the costs, Gieringer estimated the costs only from drug delay; he does not attempt to quantify the costs associated with drug loss. Nevertheless, his conclusion is clear: the FDA is responsible for more lives lost than lives saved.
The FDA has no incentive to get drugs out earlier.
It takes 12 to 15 years for new drugs and medical devices to be approved
The alternative are voluntary assurance systems
Society has three broad approaches to quality and safety assurance:
1. Voluntary practices and institutions, such as reputation, knowers, and middlemen, which assure quality and safety because it is profitable to satisfy the consumer and live up to one's promises
2. Tort remedy, by which consumers who are harmed or cheated may sue under the rubrics of fraud, false representation, breach of warranty, negligence, malpractice, and so on
3. Governmentally imposed restrictions on voluntary exchange, whereby government attempts to determine the quality and safety of goods and services, and prohibits exchange until it has given permission
These kinds of systems need to be examined as the rate of new technology introduction increases and society will be allowing more death by not introducing new technology with proper speed.
Technological solutions are real time modeling and individual assessment before administering treatment and real time monitoring during and after treatment. Instead of taking 12-15 years to guess about drug effects upon a population, get accurate models of each person and model the effect of each drug for each individual.