E-Library - Information At Your Fingertips: Printer Friendly 35 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 It would be absurd to presume that any evidence, which a reasonable mind may accept as adequate, would yield the same kind of evidence as clinical investigations by scientific experts, meta-analyses, systematic reviews, national clinical practice guidelines, and recommendations of international medical organizations. It also requires a review of the physiology of the reproductive system, the classification, regulatory status, and mechanism of hormonal contraceptives in other countries, and a review of all available scientific data in medical journals and textbooks. An independent evidence review group composed of leading experts in the fields of pharmacodynamics, medical research, evidence-based medicine, and other relevant fields may also be constituted to review the available data.[36] What the law requires is not just a reasonable mind, but also scientific, medical, and pharmacological expertise. The necessary evidence in registration, certification, and re-certification proceedings cannot be equated to that required in a quasi-judicial tribunal. Quasi-judicial agencies are also required to adjudicate only on the evidence submitted by the parties.[37] In certification and re-certification proceedings, however, the Food and Drug Administration cannot merely rely on the evidence submitted by the Marketing Authorization Holder or of the oppositors. The law requires it to use the "best evidence available."[38] This means that it must consider external and extraneous evidence not necessarily submitted by the applicants or oppositors, such as clinical studies, medical journals and textbooks, and safety guidelines and standards in other countries. Rulings of quasi-judicial agencies are also appealable to the Court of Appeals under Rule 43 of the Rules of Court.[39] The Court of Appeals, however, does not have the technical expertise to review or overrule the scientific, medical, and pharmacological data of the Food and Drug Administration. Even the law recognizes the Food and Drug Administration's expertise on the matter: (a) Abortifacient refers to any drug or device that induces abortion or the destruction of a fetus inside the mother's womb or the prevention of the fertilized ovum to reach and be implanted in the mother's womb upon determination of the FDA.[40] (Emphasis supplied) In Imbong v. Ochoa,[41] this Court further recognized that the Food and Drug Administration "has the expertise to determine whether a particular hormonal contraceptive or intrauterine device is safe and non-abortifacient."[42] The Court of Appeals does not have the required medical and pharmacological background to review the numerous clinical studies performed by scientific, medical, and pharmacological experts, metaanalyses, systemic reviews, medical journals, and textbooks. It is not equipped to conclude matters of a highly technical nature. It cannot adjudicate on conflicting scientific studies to conclude which would have more weight. For this reason, the law specifically assigned the procedure to a specialized agency as part of its executive regulatory function. 4/21/2020, 9:19 AM