History
The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the FDA. All three groups felt that drug approvals were taking far too long. Pharmaceutical companies had to wait to begin to recoup the costs of research and development. The FDA estimated that a delay of one month in a review’s completion cost its sponsor $10 million. The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market. The FDA had not received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be used to speed drug review. The 1992 law became possible when the FDA and industry agreed on setting target completion times for reviews and the promise these fees would supplement federal appropriations instead of replacing them.
Read more about this topic: Prescription Drug User Fee Act
Famous quotes containing the word history:
“The history of the genesis or the old mythology repeats itself in the experience of every child. He too is a demon or god thrown into a particular chaos, where he strives ever to lead things from disorder into order.”
—Ralph Waldo Emerson (1803–1882)
“Culture, the acquainting ourselves with the best that has been known and said in the world, and thus with the history of the human spirit.”
—Matthew Arnold (1822–1888)
“Considered in its entirety, psychoanalysis won’t do. It’s an end product, moreover, like a dinosaur or a zeppelin; no better theory can ever be erected on its ruins, which will remain for ever one of the saddest and strangest of all landmarks in the history of twentieth-century thought.”
—Peter B. Medawar (1915–1987)