Alliance For The Family Foundation, Philippines, Inc., et al. vs. Hon. Garin, et al.

Administrative agencies exercising regulatory or quasi-judicial powers must observe the minimum requirements of procedural due process (notice and hearing) when their actions affect the rights of parties; acts tainted with grave abuse of discretion for violating due process are subject to the SC's power of judicial review.

The SC previously issued an August 24, 2016 Decision remanding the case to the FDA to conduct hearings on the procured and administered contraceptive drugs and devices (including Implanon and Implanon NXT) to determine if they are abortifacients. The SC also directed the FDA and the Department of Health (DOH) to formulate rules of procedure containing minimum due process requirements. The respondents filed an Omnibus Motion for partial reconsideration of this decision.

• Filed in SC: Original actions for Certiorari, Prohibition, Mandamus (G.R. No. 217872) and Contempt of Court (G.R. No. 221866).
• Decision of SC: August 24, 2016 Decision remanded the case to the FDA and maintained the TRO.
• Elevated to SC: Respondents filed an Omnibus Motion seeking partial reconsideration of the August 24, 2016 Decision.

• The Food and Drug Administration (FDA) certified, recertified, procured, and administered several contraceptive drugs and devices, specifically Implanon and Implanon NXT.
• Petitioners filed various oppositions against these actions, asserting that the questioned contraceptives fell within the definition of an "abortifacient" under Section 4(a) of the Reproductive Health Law (RH Law) because their secondary mechanism of action induces abortion or prevents the fertilized ovum from implanting in the mother's womb.
• The FDA completely ignored the petitioners' oppositions and proceeded with the registration, recertification, procurement, and distribution of the contraceptives.
• The SC previously enjoined the FDA from processing these specific contraceptives until due process was observed.
• Respondents filed an Omnibus Motion arguing that the FDA's actions were purely regulatory and exempt from due process requirements.

• The questioned contraceptive drugs and devices (Implanon and Implanon NXT) are abortifacients under Section 4(a) of the RH Law.
• The FDA violated their constitutional right to due process by failing to act upon, address, or even answer the various oppositions and letters they filed against the product registration and distribution.

• The FDA's acts of registering, recertifying, procuring, and administering contraceptives were done in the exercise of its regulatory powers, not quasi-judicial powers, and thus do not require compliance with due process (notice and hearing).
• The standards of procedural due process in Ang Tibay v. CIR are inapplicable because substantial evidence cannot measure whether a drug is an abortifacient, and the FDA is not bound by technical rules of evidence.
• The courts lack jurisdiction and competence to review the FDA's scientific findings on the non-abortifacient character of the drugs.
• The SC's TRO causes inordinate delay, hampering the implementation of the RH Law and causing a nationwide stockout of family planning supplies.

• Procedural Issues:
  • Whether the SC has the power of judicial review over the acts of the FDA done in the exercise of its regulatory powers.
• Substantive Issues:
  • Whether the FDA is required to observe the requirements of procedural due process (notice and hearing) in the certification and recertification of contraceptive drugs and devices.

• Procedural: Yes. The SC has the power to review all acts and decisions of any branch or instrumentality of the Government where there is a commission of grave abuse of discretion. The FDA's invocation of its regulatory power cannot curtail the SC's power of judicial review, especially when there is a violation of the constitutional mandate that no person shall be deprived of life, liberty, or property without due process of law. A court is not incompetent to review FDA findings simply because the issues involve weighing scientific evidence.
• Substantive: Yes. The FDA must comply with procedural due process. The petitioners were deprived of their constitutional right to due process when the FDA completely ignored their oppositions. While a formal trial-type hearing is not essential, the essence of due process requires that parties be given a fair and reasonable opportunity to explain their side and present supporting science-based evidence. The FDA's own procedural steps for approval require the use of the "best evidence available" and the consideration of conflicting evidence, which makes the issuance of notices and public comments meaningless if oppositions are ignored.

• Due Process in Administrative Proceedings (Ang Tibay Doctrine) — Administrative bodies must respect the cardinal rights of parties, which include:
  1. The right to a hearing (to present one's case and submit evidence).
  2. The tribunal must consider the evidence presented.
  3. The decision must have something to support itself.
  4. The evidence must be substantial.
  5. The decision must be rendered on the evidence presented at the hearing or contained in the record.
  6. The tribunal must act on its own independent consideration of the law and facts.
  7. The body must render its decision in such a manner that parties know the issues involved and the reasons for the decision.
  8. Application: The SC applied this doctrine to rule that the FDA's failure to consider the petitioners' oppositions violated their right to be heard and to have their evidence considered.
• Quasi-Legislative vs. Quasi-Judicial Power — Quasi-legislative power is the authority to adopt rules intended to carry out legislative policy (generally does not require notice and hearing). Quasi-judicial power is the authority to determine questions of fact and apply legislative policy to determine rights and liabilities (requires jurisdiction and due process/notice and hearing).
  • Application: The SC clarified that even if the FDA claims to exercise "regulatory" or "enabling" powers (a subcategory of quasi-judicial power), it is not exempt from the twin requirements of notice and hearing when determining the rights of oppositors.

• "The mere fact that the RH Law was declared as not unconstitutional does not permit the respondents to run roughshod over the constitutional rights, substantive and procedural, of the petitioners."
• "Where the denial of the fundamental right to due process is apparent, a decision rendered in disregard of that right is void for lack of jurisdiction. This rule is equally true in quasi-judicial and administrative proceedings..."
• "Administrative due process cannot be fully equated with due process in its strict judicial sense, for in the former a formal or trial-type hearing is not always necessary... The essence of due process is simply to be heard..."

• Ang Tibay v. CIR — Controlling precedent. Cited to establish the seven cardinal rights of parties in administrative proceedings, which the FDA violated.
• Imbong v. Ochoa — Followed. Cited as the standard for determining whether a contraceptive drug or device is an abortifacient under the RH Law.
• Perez v. Philippine Telegraph and Telephone Company & Vivo v. Pagcor — Cited to explain that a formal trial-type hearing is not essential to satisfy administrative due process; a fair and reasonable opportunity to explain one's side is sufficient.

• Article III, Section 1 of the 1987 Constitution — No person shall be deprived of life, liberty, or property without due process of law. Applied to invalidate the FDA's certifications issued without hearing the petitioners.
• Republic Act No. 10354 (RH Law) & its Implementing Rules and Regulations (RH-IRR) — Specifically Section 7.04, Rule 7, which mandates the FDA to use the "best evidence available" and consider conflicting evidence in determining if a drug is an abortifacient.
• Republic Act No. 9711 (FDA Act of 2009) — Section 5 (amending R.A. No. 3720) mandates the FDA to observe due process before ordering the ban, recall, or withdrawal of health products.
• Executive Order No. 247, Section 9 — Applied to modify the appellate procedure. Decisions of the FDA/Secretary of Health must be appealed to the Office of the President before recourse to the courts.