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:
“There is nothing truer than myth: history, in its attempt to “realize” myth, distorts it, stops halfway; when history claims to have “succeeded” this is nothing but humbug and mystification. Everything we dream is “realizable.” Reality does not have to be: it is simply what it is.”
—Eugène Ionesco (b. 1912)
“The best history is but like the art of Rembrandt; it casts a vivid light on certain selected causes, on those which were best and greatest; it leaves all the rest in shadow and unseen.”
—Walter Bagehot (1826–1877)
“The history of a soldier’s wound beguiles the pain of it.”
—Laurence Sterne (1713–1768)