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a quasi-judicial function when it determines what the law is and adjudicates the
rights of the parties before it.[28]
An administrative agency's quasi-judicial functions should not be confused with its
administrative or executive functions. A purely executive or administrative function
connotes, or pertains, to "administration, especially management, as by
managing or conducting, directing or superintending, the execution,
application, or conduct of persons or things." It does not entail an
opportunity to be heard, the production and weighing of evidence, and a
decision or resolution thereon.[29]
On the other hand, an administrative agency exercises its quasi-judicial function
when "it performs in a judicial manner an act which is essentially of an executive or
administrative nature."[30] Thus, while the administrative agency is not expected to
act like a court of law, it is still expected to listen to both sides and to render a
decision explaining its reasons for its decision.[31]
As previously discussed, the Food and Drug Administration requires scientific,
medical, and pharmacological data as well as numerous clinical studies in its
registration, certification, and re-certification procedures. Due to the highly technical
nature of the processes, none of the standards and procedures required in quasijudicial proceedings would be applicable to it.
The standard of evidence required to establish the existence of a fact before a quasijudicial tribunal is substantial evidence.[32] Substantial evidence is defined as "that
amount of relevant evidence which a reasonable mind might accept as adequate to
justify a conclusion."[33]
The United States Food and Drug Administration defines substantial evidence of a
drug's effectiveness as:
"evidence consisting of adequate and well-controlled investigations,
including clinical investigations, by experts qualified by scientific training
and experience to evaluate the effectiveness of the drug involved, on the
basis of which it could fairly and responsibly be concluded by such
experts that the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or suggested
in the labeling or proposed labeling thereof."[34]
Republic Act No. 10354 mandates that the Food and Drug Administration use the
"best evidence available" to ascertain whether a contraceptive is non-abortifacient:
c) In making its determination, the FDA shall use the best evidence
available, including but not limited to: meta-analyses, systematic reviews,
national
clinical
practice
guidelines
where
available,
and
recommendations of international medical organizations.[35]
4/21/2020, 9:19 AM
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