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 modern art is also the history of the progressive loss of art’s audience. Art has increasingly become the concern of the artist and the bafflement of the public.”
—Henry Geldzahler (1935–1994)
“I believe that in the history of art and of thought there has always been at every living moment of culture a “will to renewal.” This is not the prerogative of the last decade only. All history is nothing but a succession of “crises”Mof rupture, repudiation and resistance.... When there is no “crisis,” there is stagnation, petrification and death. All thought, all art is aggressive.”
—Eugène Ionesco (b. 1912)
“There is no example in history of a revolutionary movement involving such gigantic masses being so bloodless.”
—Leon Trotsky (1879–1940)