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.
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