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:
“Let it suffice that in the light of these two facts, namely, that the mind is One, and that nature is its correlative, history is to be read and written.”
—Ralph Waldo Emerson (1803–1882)
“The history of American politics is littered with bodies of people who took so pure a position that they had no clout at all.”
—Ben C. Bradlee (b. 1921)
“False history gets made all day, any day,
the truth of the new is never on the news
False history gets written every day
...
the lesbian archaeologist watches herself
sifting her own life out from the shards she’s piecing,
asking the clay all questions but her own.”
—Adrienne Rich (b. 1929)