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
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“While the Republic has already acquired a history world-wide, America is still unsettled and unexplored. Like the English in New Holland, we live only on the shores of a continent even yet, and hardly know where the rivers come from which float our navy.”
—Henry David Thoreau (1817–1862)
“We said that the history of mankind depicts man; in the same way one can maintain that the history of science is science itself.”
—Johann Wolfgang Von Goethe (1749–1832)
“The history is always the same the product is always different and the history interests more than the product. More, that is, more. Yes. But if the product was not different the history which is the same would not be more interesting.”
—Gertrude Stein (1874–1946)