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:
“I saw the Arab map.
It resembled a mare shuffling on,
dragging its history like saddlebags,
nearing its tomb and the pitch of hell.”
—Adonis [Ali Ahmed Said] (b. 1930)
“The one duty we owe to history is to rewrite it.”
—Oscar Wilde (1854–1900)
“I am ashamed to see what a shallow village tale our so-called History is. How many times must we say Rome, and Paris, and Constantinople! What does Rome know of rat and lizard? What are Olympiads and Consulates to these neighboring systems of being? Nay, what food or experience or succor have they for the Esquimaux seal-hunter, or the Kanaka in his canoe, for the fisherman, the stevedore, the porter?”
—Ralph Waldo Emerson (1803–1882)