
126 • Pharmaceutical Supply Chain
to provide proof of the eectiveness as well as safety of drugs (called proof
of ecacy) before FDA approval. e nature of the evidence for eective-
ness had to be much more rigorous, and developed by those qualied to
do so. e FDA was given greater oversight of clinical investigations, and
patients involved in drug experiments had to supply informed consent that
they were subjects in a drug study. In addition, this amendment required
drug advertising to disclose accurate information about side eects and
ecacy of treatments. e law gave greater authority to FDA inspectors
to access certain drug manufac