E-Library - Information At Your Fingertips: Printer Friendly 9 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 mandate of the Court in Imbong that the IRR should be amended to conform to it. More importantly, the Court notes that Step 5 requires the FDA to issue a notice to all concerned MAHs and require them to submit scientific evidence that their product is non-abortifacient; and that Step 6 requires the posting of the list of contraceptive products which were applied for re-certification for public comments in the FDA website. If an opposition or adverse comment is filed on the ground that the drug or devise has abortifacient features or violative of the RH Law, based on the pronouncements of the Court in Imbong or any other law or rule, the FDA is dutybound to take into account and consider the basis of the opposition. To conclude that product registration, recertification, procurement, and distribution of the questioned contraceptive drugs and devices by the FDA in the exercise of its regulatory power need not comply with the requirements of due process would render the issuance of notices to concerned MAHs and the posting of a list of contraceptives for public comment a meaningless exercise. Concerned MAHs and the public in general will be deprived of any significant participation if what they will submit will not be considered. Section 7.04, Rule 7 of the IRR of the RH Law (RH-IRR),[35] relied upon by the respondents in support of their claims, expressly allows the consideration of conflicting evidence, such as that supplied by the petitioners in support of their opposition to the approval of certain contraceptive drugs and devices. In fact, the said provision mandates that the FDA utilize the "best evidence available" to ensure that no abortifacient is approved as a family planning drug or device. It bears mentioning that the same provision even allows an independent evidence review group (ERG) to ensure that evidence for or against the certification of a contraceptive drug or device is duly considered. Structure of the FDA As earlier mentioned, the respondents argue that the Decision "wreaked havoc on the organizational structure of the FDA, whose myriad of functions have been carefully delineated under R.A. No. 9711 IRR."[36] Citing Section 7.04, Rule 7 of the RH-IRR, the FDA insists that the function it exercises in certifying family planning supplies is in the exercise of its regulatory power, which cannot be the subject of judicial review, and that it is the Director-General of the FDA who exercises quasi-judicial powers, citing Section 2(b) of Article 3, Book I of the RH-IRR.[37] The FDA wants the Court to consider that, as a body, it has a distinct and separate personality from the Director-General, who exercises quasi-judicial power. The Court cannot accommodate the position of the respondents. Section 6(a) of R.A. No. 3720, as amended by Section 7 of R.A. No. 9711,[38] provides that "(a) The FDA shall be headed by a director-general with the rank of undersecretary, x x x." How can 4/21/2020, 9:19 AM