norml09 - 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 Foods Drug and Cosmetic Act (FDCA) ° A shift
began away from anecdotal evidence to 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
First, Congress accepted new drugs which have been
approved by FDA's experts as safe and effective for use in
treatments based on substantial scientific evidence°
21 U.S.Co 321(p) and 355 (so-called '_NDA_approved drugs")°
Second_ Congress accepted those drugs _generally
recognized_ among experts qualified by scientific training
and experience to evaluate the safety and effectiveness of
drugs_ as safe and effective_ _' based on substantial
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