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:
“Don’t give your opinions about Art and the Purpose of Life. They are of little interest and, anyway, you can’t express them. Don’t analyse yourself. Give the relevant facts and let your readers make their own judgments. Stick to your story. It is not the most important subject in history but it is one about which you are uniquely qualified to speak.”
—Evelyn Waugh (1903–1966)
“Like their personal lives, women’s history is fragmented, interrupted; a shadow history of human beings whose existence has been shaped by the efforts and the demands of others.”
—Elizabeth Janeway (b. 1913)
“This above all makes history useful and desirable: it unfolds before our eyes a glorious record of exemplary actions.”
—Titus Livius (Livy)