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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
 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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