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:
“Anyone who is practically acquainted with scientific work is aware that those who refuse to go beyond fact rarely get as far as fact; and anyone who has studied the history of science knows that almost every great step therein has been made by the “anticipation of Nature.””
—Thomas Henry Huxley (1825–95)
“We don’t know when our name came into being or how some distant ancestor acquired it. We don’t understand our name at all, we don’t know its history and yet we bear it with exalted fidelity, we merge with it, we like it, we are ridiculously proud of it as if we had thought it up ourselves in a moment of brilliant inspiration.”
—Milan Kundera (b. 1929)
“A man will not need to study history to find out what is best for his own culture.”
—Henry David Thoreau (1817–1862)