norml08 - Page 21
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This state of affairs became unsatisfactory to a majority of
the American people. In 1906, Congress intervened with the
passage of the Food, Drug and Cosmetic Act (FDCA) o A shift
began away from anecdotal evidence tc objectively conducted
scientific research, away from uninformed opinions of lay
persons and local doctors to expert opinions of specialists
trained to evaluate the safety and effectiveness of drugs,
and away from totally democratic decision-making to
oversight by the Federal Government°
By 1969, Congress had developed detailed Federal
statutory criteria under the FDCA to determine whether drugs
are acceptable for medical use. Those deemed acceptable can
be marketed nationally_ Those deemed unacceptable are
subject to Federal seizure if marketed interstate° The FDCA
is a very complex regulatory scheme not easily summarized.
However, it is fair to say that drugs falling into one of
four FDCA categories were accepted by Congress for medical
USeo
Firsts Congress accepted new drugs which have been
approved by EDA's experts as safe and effective for use in
treatment, based on substantial scientific evidence°
21 U.S.C. 321(p) and 355 (so-called "NDA-approved drugs").
Seconds Congress accepted those drugs "generally
recognized, among experts qualified by scientific training
and experience to evaluate the safety and effectiveness of
drugsr as safe and effective," based on substantial
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