Part III: The Innovation Conundrum

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Part III: The Innovation Conundrum Blaming the Messenger

 

Part three of the four part series

if you are interested:

 

http://www.gooznews.com/archives/000904.html

Blaming the Messenger

Contrary to popular belief, the regulatory environment for new drug development has grown less stringent over the past two decades, not more so. A succession of changes in food and drug laws plus new rules propagated by the FDA itself, which began when an alarmed HIV/AIDS patient community began clamoring for new drugs to treat that deadly disease, substantially liberalized the rules under which new drug development takes place.

The Prescription Drug User Fee Act of 1992 sharply reduced the amount of time that FDA reviewers may take to evaluate new drugs once all the data from confirmatory clinical trials have been submitted to the agency. Regulations put in place the same year allowed new drug applicants to measure surrogate markers, not clinical