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In 1962 the Drug Amendments Act, called "thalidomide "thalidomide law,"was passed in the wake or the thalidomide scare. Thalidomide was never proven effective for anything in animal tests. It was designed for seizure control but has no antiseizure properties; Its disastrous effects on people were discovered only after it was marketed. A provision of the new act was grace period for drugs approved by the FDA between 1938 (when the agency was creited) and 4962. These drugs stayed on the market without having to prove they were effective, at least at first. By October 1964 drug companies had to satisfy the FDA that pre- 1962 drugs were effective or pull them off the market. Many disappeared from pharmacists' shelves.
Source: "Safety & Effectiveness," Time, 83 (13 March 1964) 82
Disaster Averted.
On 20 November 1961 West German pediatrician Dr. Widukind Lenz presented his findings that thalidomide caused phocomelia to a meeting...
This section contains 358 words (approx. 2 pages at 300 words per page) |
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