Case Summary (G.R. No. 217872)
Procedural Posture and Reliefs Sought
Petitioners filed: (1) Petition for Certiorari, Prohibition, Mandamus with prayer for TRO and/or other injunctive relief (G.R. No. 217872); and (2) Petition for Contempt (G.R. No. 221866). The respondents filed an Omnibus Motion seeking partial reconsideration of the Court’s August 24, 2016 decision. The Supreme Court’s April 26, 2017 resolution modifies the prior decision, denies the Omnibus Motion, denies the contempt petition for lack of basis, and issues remand and specific directives to the FDA and DOH.
Core Rulings and Immediate Directives
- The Court remanded the matter to the FDA and ordered the FDA to observe the basic requirements of due process by conducting a hearing and allowing petitioners to be heard regarding the re‑certified, procured and administered contraceptive drugs and devices (including Implanon and Implanon NXT) to determine whether they are abortifacients.
- The FDA was directed to formulate rules of procedure for screening, evaluation and approval of contraceptive drugs/devices under RA 10354, with minimum due process content (publication/notice/hearing; intervention by interested parties; adherence to the constitutional standard as adopted under RA 10354 regarding allowable contraceptives; resolving reasonable doubts in favor of unborn life; compliance with administrative due process principles as in Ang Tibay).
- The DOH, in coordination with agencies, was directed to formulate rules/guidelines governing purchase and distribution under Section 9 of RA 10354, including procedural safeguards (publication/notice/hearing; intervention) and specific regulatory details to prevent use as abortifacients.
- The DOH was ordered to generate and distribute a complete, correct list of government reproductive health programs/services under RA 10354 to serve as the template for duty‑to‑inform obligations.
- The FDA was ordered to commence the necessary hearing within 30 days (as earlier directed), and the TRO was maintained pending resolution; the Court later modified the schedule to require the FDA to decide within 60 days from submission for resolution.
Respondents’ Main Arguments in Omnibus Motion
- The FDA acted within its regulatory powers (issuing CPRs, re‑certifications, procurement, administration) and thus notice and hearing were unnecessary because the issuance of CPR was not quasi‑judicial and did not adjudicate rights through adversarial proceedings. Respondents emphasized internal functional delineations (quasi‑judicial functions of the Director‑General versus regulatory/administrative functions of the FDA) to argue exemption from procedural due process.
- Ang Tibay procedural standards allegedly do not apply because: (a) substantial evidence is not an appropriate standard for determining abortifacience; (b) courts lack competence to review FDA scientific findings on abortifacience; (c) the FDA is not bound by Rules of Court evidentiary rules; and (d) FDA findings are not subject to res judicata or stare decisis. Respondents asserted that requiring public hearings would delay RH Law implementation and cause supply disruptions.
Judicial Review and Scope of Court’s Power
The Court reaffirmed its power to review administrative acts where grave abuse of discretion amounting to lack or excess of jurisdiction is alleged. The FDA’s invocation of regulatory power does not place its acts beyond judicial review. When constitutional rights (notably procedural due process) are implicated, the Court may review FDA action regardless of whether the FDA acted in ministerial, quasi‑judicial, or regulatory capacity.
Quasi‑Legislative vs. Quasi‑Judicial Functions and Due Process
- Quasi‑legislative (rulemaking) generally does not require notice and hearing except where the legislature so mandates.
- Quasi‑judicial functions, involving determination of rights and liabilities based on facts and law, ordinarily require jurisdiction plus observance of due process (notice and hearing).
- The Court interpreted “regulatory” or “enabling” powers (as described in administrative law sources) as a subcategory of quasi‑judicial determinative powers when they affect rights, meaning that certain regulatory issuance (e.g., CPR certification that affects protected interests) may trigger due process protections.
Finding of Denial of Procedural Due Process
The Court held that petitioners were deprived of procedural due process because the FDA failed to act upon or address oppositions filed by petitioners against product registration, re‑certification, procurement and distribution. The FDA’s process, as implemented, either ignored or did not meaningfully consider petitioners’ oppositions alleging abortifacient characteristics of the drugs/devices. The Court emphasized that statutory/regulatory steps (including notice to MAHs and posting of products for public comment) are meaningful only if oppositions and public comments are actually considered and addressed.
FDA Procedures and Identified Deficiencies
The Court reviewed the FDA’s articulated multi‑step process for identification, review, public posting (Step 5: notice to MAHs for non‑abortifacient evidence; Step 6: posting for public comment; Step 7: technical and scientific evaluation) and found procedural deficiencies:
- Public comment opportunities were limited to re‑certification, not initial certification, contravening the Court’s Imbong mandate to amend IRR for conformity.
- The FDA’s failure to consider petitioners’ oppositions rendered the posting and notice procedures meaningless.
- Section 7.04 of the RH‑IRR mandates use of the “best evidence available” and allows an independent Evidence Review Group (ERG); these provisions permit consideration of conflicting evidence and require the FDA to weigh oppositions.
Nature of the Hearing Required — Not Trial‑Type
The Court clarified that due process in this administrative context does not require a formal, trial‑type hearing. Administrative due process is satisfied by a fair and reasonable opportunity to present science‑based evidence and arguments, and by the agency’s consideration of that material. The FDA must afford oppositors a genuine opportunity to present evidence and must consider and address such evidence, but technical trial procedures are not required.
Standard of Proof and Scientific Evidence
Under Rule 133, Sec. 5 (Rules of Court), a fact before administrative bodies may be established by substantial evidence. For FDA certification/re‑certification, “substantial evidence” means the best scientific evidence available — meta‑analyses, systematic reviews, clinical guidelines, international medical organization recommendations, and expert review (ERG). The FDA may and should consult extraneous scientific sources and experts. The FDA is not strictly bound by judicial rules of evidence or by stare decisis, and it may update or cancel certifications motu proprio on new scientific findings.
Competence of Courts and Reviewability of Scientific Findings
The Court rejected the claim that courts lack competence to review FDA findings because of the scientific nature of the issues. Judicial review is available and necessary where due process issues arise. Courts may weigh scientific evidence presented by both sides in reviewing whether the agency complied with statutory standards and constitutional due process; specialized agency expertise is relevant but does not oust judicial review for grave abuse of discretion.
Appellate Path and Modification Re: Appeals
The Court modified its earlier statement allowing direct appeal to the Court of Appeals. By statute (RA 3720, Sec. 32; E.O. No. 247, Sec. 9), FDA decisions are appealable to the Secretary of Health, and from there to the Office of the President; recourse to courts follows exhaustion of administrative remedies. Because the Secretary of Health is a party in these proceedings, the Court directed that appeals from FDA decisions in this matter should be to the Office of the President (not the Secretary), in accordance with E.O. No. 247, Sec. 9.
Temporary Restraining Order (TRO) and Timing
The Court maintained the TRO as to the specific contraceptives challenged (including Implanon and Implanon NXT) pending the FDA’s observance of due process and resolution. Lifting the TRO before the summary hearing and administrative determination would be premature. If, after due process and FDA decision, the products are found non‑abortifacient, the TRO would be deemed lifted. The Court criticized the FDA for delay in conducting the summary hearing and ordered resolution within sixty (60) days from submission for resolution.
On Delay and Responsibility
The Court held that delays in distribution attributable to judicial review were the consequence of the FDA’s failure to comply with the Court’s prior orders to conduct a summary hearing and to meaningfully consider oppositions. Had the FDA promptly held the hearing and resolved oppositions, the controversy would have been clarified earlier.
Final Disposition
- The Omnibus Motion was denied; the contempt petition was denied for lack of concrete basis.
- The August 24, 2016 Decision was modified: FDA was ordered to consider oppositions (including Implanon/Implanon NXT) under RA 10354 standards (as construed in Imbong), decide within sixty (60) days from submission, and amend the IRR to conform with Imbong. Upon FDA promulgation of its decision, the TRO would be lifted if the drugs/devices are found non‑abortifacient. Appeals from FDA decision in this matter should be to the Office of the Presi
Case Syllabus (G.R. No. 217872)
Procedural Posture and Relief Sought
- The subject is the Omnibus Motion filed by respondents through the Office of the Solicitor General seeking partial reconsideration of the Court's August 24, 2016 Decision resolving: (1) Petition for Certiorari, Prohibition, Mandamus with Prayer for Issuance of a TRO and/or Writs (G.R. No. 217872); and (2) Petition for Contempt (G.R. No. 221866).
- The August 24, 2016 Decision remanded G.R. No. 217872 to the Food and Drug Administration (FDA) to observe due process in hearings on re-certified, procured and administered contraceptive drugs and devices (including Implanon and Implanon NXT) and to determine whether they are abortifacients.
- The Decision directed the FDA and the Department of Health (DOH) to formulate and amend procedures and IRR provisions, and it denied the motion to lift the TRO pending resolution; the contempt petition was denied for lack of concrete basis.
- The Omnibus Motion sought relief from those findings and orders, including lifting the TRO.
Parties and Their Roles
- Petitioners: Alliance for the Family Foundation, Philippines, Inc. (ALFI), Atty. Maria Concepcion S. Noche (in her own behalf and as counsel/president), and listed individual petitioners.
- Respondents: Hon. Janette L. Garin (Secretary-designate, DOH), Nicolas B. Lutero III (Assistant Secretary, OIC, FDA), Maria Lourdes C. Santiago (Officer-in-Charge, Center for Drug Regulation and Research).
- Office of the Solicitor General prosecuted the Omnibus Motion on behalf of respondents.
Core Legal and Administrative Questions Presented
- Whether the FDA’s acts of registering, re-certifying, procuring, and administering contraceptive drugs and devices (including Implanon and Implanon NXT) undertaken in the exercise of regulatory power required compliance with procedural due process (notice and hearing).
- Whether the procedural due process standards laid down in Ang Tibay v. CIR apply to FDA certification/re-certification proceedings.
- Whether the courts can review FDA determinations on the non-abortifacient character of contraceptives or whether such determinations are beyond judicial competence given their scientific nature.
- Whether the FDA’s internal organizational delineation of quasi-judicial versus regulatory powers places certain FDA acts beyond judicial review.
Respondents’ Arguments (Part 1 — Regulatory Power and Due Process)
- Respondents argued their actions were exercised pursuant to the FDA’s regulatory powers, not adjudicatory powers, and thus did not require notice and hearing as in adversarial proceedings.
- They relied on the FDA’s IRR provisions delineating quasi-judicial powers (exercised by the Director-General) and separate regulatory/administrative powers to contend that issuance of Certificates of Product Registration (CPR) under RH-IRR Rule 7.04 did not involve adversarial adjudication.
- They described the CDRR’s internal examination and testing process for non-abortifacience to argue that due process requirements were inapplicable to their acts.
- Respondents contended that the Decision disrupted the FDA’s organizational structure and sought lifting of the TRO as it hampered provision of reproductive health needs.
Respondents’ Arguments (Part 2 — Inapplicability of Ang Tibay Standards)
- Respondents claimed Ang Tibay procedural due process standards were inapplicable because:
- Substantial evidence could not be used to determine abortifacience.
- Courts lacked jurisdiction or competence to review FDA scientific findings.
- The FDA was not bound by Rules of Court on admissibility and presentation of evidence.
- FDA findings could not be subject to res judicata or stare decisis.
- They maintained Implanon and Implanon NXT were not abortifacients and argued that affording oppositors procedural opportunities would delay RH Law implementation and distribution of contraceptives.
Court’s Disposition of the Omnibus Motion
- The Court denied the Omnibus Motion but issued clarifications and modifications to the prior Decision.
- The Court reaffirmed remand to the FDA to consider oppositions and to observe procedural due process in certification/re-certification of contraceptives, including Implanon and Implanon NXT.
- The Court modified the appellate route: after FDA decision, appeal should be to the Office of the President pursuant to Section 9 of E.O. No. 247 rather than directly to the Court of Appeals given the Secretary of Health was a party.
- The Court ordered the FDA to decide the oppositions within sixty (60) days from the date the case is deemed submitted for resolution; upon promulgation, the TRO would be lifted if the drugs are found non-abortifacients.
- The Court maintained that the motion to lift the TRO was denied pending the FDA’s compliance with due process requirements; the contempt petition remained denied for lack of concrete basis.
Judicial Review and Scope of Court’s Power
- Administrative powers are classified as quasi-legislative and quasi-judicial; legislative rules generally do not require notice and hearing except when the legislature mandates fact-based investigation.
- Quasi-judicial power involves determination of facts affecting rights and liabilities and requires acquisition of jurisdiction and observance of due process (notice and hearing).
- The Court held it retains power to review acts and decisions where there is grave abuse of discretion, including in acts characterized as regulatory, when constitutional due process rights are implicated.
- The FDA cannot evade judicial review by labeling actions as regulatory; prior jurisprudence demonstrates Court review over regulatory acts when grave abuse is alleged.
Due Process Findings and Ang Tibay Standards
- The Court found petitioners were deprived of constitutional due process because respondents failed to act on or meaningfully address oppositions filed by petitioners against product registration, recertification, procurement, and distribution.
- The FDA’s practice of relying on procedural technicalities rather than addressing oppositions was deemed deplorable; correspondence from petitioners remained unanswered.
- The Court reiterated Ang Tibay’s cardinal rights in administrative proceedings:
- Right to a hearing and to present evidence;
- Tribunal must consider evidence presented;
- Decision must have supporting basis and substantial evidence;
- Decision must be rendered on evidence in the record;
- Independent consideration of law and facts by the deciding body;
- Decision should disclose issues and reasons.
- The Court held that denial of due process in administrative proceedings is jurisdictional and renders resulting decisions void.
FDA Certification/Re-certification Procedures (Steps Outlined by FDA/CDRR)
- Step 1: Identify contraceptive products in database; create database with details (generic name, dosage, brand, registration number, manufacturer, MAH, CPR validity).
- Step 2: Identify contraceptives classified as essential medicines in the Philippine Drug Formulary.
- Step 3: Retrieve product files and CPR duplicates; create product history database (initial, renewal, amendment, variation applications).
- Step 4: Conduct preliminary review of female reproductive physiology, hormonal contraceptive classification, regulatory status in benchmark countries, and mechanism of action based on reputable sources (journals, meta-analyses, systematic reviews, foreign regulatory evaluations, textbooks).
- Step 5: Issue notice to all concerned Market Authorization Holders (MAHs) requiring submission of scientific evidence that their product is non-abortifacient as defined in RH Law and Imbong.
- Step 6: Post list of contraceptive products applied for re-ce