E-Library - Information At Your Fingertips: Printer Friendly 38 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 Post Marketing Surveillance is conducted through sampling, inspecting drug establishments and outlets, and investigating adverse drug reactions.[46] Marketing Authorization Holders are likewise required to submit Periodic Safety Update Reports at regular intervals and Post-Authorization Safety Studies/Post-Authorization Efficacy Studies.[47] Marketing Authorization Holders may also conduct a Phase IV clinical trial when necessary.[48] Certifications of contraceptives cannot be considered "final and executory" if the Food and Drug Administration conducts further examinations on patients for health and pregnancy risks even after it certifies to its nonabortifacience or if the Marketing Authorization Holders are required to monitor their products and conduct further testing. The Food and Drug Administration's mandate under Republic Act No. 10354 to determine and certify if a contraceptive or intrauterine device is medically safe and non-abortifacient is an exercise of its regulatory function for the "[protection] and [promotion] of the right to health of the Filipino people."[49] The "right of the State as parens patriae"[50] is a role that the Food and Drug Administration, as a regulatory agency, undertakes. In a quasi-judicial proceeding, interested or affected parties must first be given the opportunity to be heard.[51] The primary consideration of administrative due process is the fairness in the procedure.[52] Proceedings that are regulatory in nature, such as certification and recertification proceedings of contraceptives, do not require trial-type proceedings. Public participation is required only as a matter of transparency.[53] Oppositors are allowed to submit any data that addresses the science involved, which they believe may overturn the findings of the Food and Drug Administration. It is the duty of the Food and Drug Administration in certification and re-certification proceedings to acknowledge and consider any opposition from the public and address their concerns. III At this point, it must be clarified that an abortifacient under Section 4 (a) of the Responsible Parenthood and Reproductive Health Act of 2012 (RH Law) is: SEC. 4. Definition of Terms. - For the purpose of this Act, the following terms shall be defined as follows: (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 the determination of the FDA. Drugs or contraceptives that merely prevent fertilization are not abortifacient. Normally, fertilization occurs when a single sperm cell penetrates an egg cell inside a 4/21/2020, 9:19 AM