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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
 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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