Facts:

The case at hand involves two petitions filed by the petitioners, who are composed of the Alliance for the Family Foundation, Philippines, Inc. (ALFI) along with several individual members, against multiple respondents, including Hon. Janette L. Garin, the Secretary-Designate of the Department of Health, and other officials from the Food and Drug Administration (FDA). The petitions seek to address claims of grave abuse of discretion by the FDA and the Department of Health following the Supreme Court's decision in the earlier case of Imbong v. Ochoa. The Supreme Court ruled on April 8, 2014, that parts of Republic Act No. 10354, also known as the Reproductive Health Law, were not unconstitutional, except for certain provisions which were deemed unconstitutional for violating constitutional rights.

On May 28, 2014, shortly after the verdict in Imbong, petitioners inquired with the FDA regarding their compliance with the Supreme Court's decision. There appeared to be a lac

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Facts:

Background of the Case

• The case arises from petitions challenging the actions of the Food and Drug Administration (FDA) and the Department of Health (DOH) concerning the re-evaluation/re-certification of certain contraceptive drugs and devices under Republic Act No. 10354 (the RH Law) and its Implementing Rules and Regulations (RH-IRR).
• The dispute originates from the Court’s earlier decision in Imbong v. Ochoa, where most provisions of the RH Law were upheld except for several that were declared unconstitutional.
• The petitioners, which include Alliance for the Family Foundation, Inc. (ALFI) and various individual petitioners represented by Maria Concepcion S. Noche, opposed the re-certification of contraceptive products on the ground that such products might be abortifacient and that the FDA’s processes lacked compliance with due process requirements.

Actions Leading to the Controversy

• In September 2014, the FDA issued a Notice inviting Marketing Authorization Holders (MAH) of fifty contraceptive drugs to apply for their re-evaluation/re-certification.
• ALFI, believing that the contraceptives in question possessed a secondary mechanism of action that could induce abortion or prevent implantation, initiated its opposition by filing a preliminary opposition (October 8, 2014) and later a formal opposition (November 24, 2014) covering seventy-seven products.
• Despite these oppositions, the FDA issued certificates of product registration for “Implanon” and “Implanon NXT” shortly after the opposition was filed, thereby prompting further contestation.

Petitioners’ Claims and Allegations

• The petitioners asserted that the FDA and DOH had violated the Court’s directives in Imbong by:
• Ignoring their oppositions and failing to hold hearings or provide adequate notice regarding the re-certification process.
• Certifying contraceptives without complying with the basic due process guarantees.
• They further argued that the issuance of certificates, particularly for “Implanon” and “Implanon NXT,” was executed in haste and in contravention of the revised constitutional standards for protecting the life of the unborn.
• The petitioners also raised concerns that the existing version of the RH-IRR still contained provisions declared unconstitutional by the Court, and that the FDA’s actions inadvertently allocated public funds for products potentially hazardous to the unborn.

Response by the Respondents and OSG

• The Office of the Solicitor General (OSG) argued that:
• The petitioners had failed to show a direct injury or transcendental importance.
• The regulatory exercise of the FDA, being a function of its administrative power and guided by scientific determination, was not subject to the same standards as judicial proceedings.
• The OSG maintained that any issues regarding the re-certification process could be remedied through the existing appeal procedures and that a circular or administrative directive carries the force of law.
• In their Reply, the petitioners reiterated that the Constitution mandates that any potential risks to the life of the unborn must be addressed by affording full due process to opposers, highlighting the need for a fair hearing as an essential safeguard.

Procedural Developments and Relief Sought

• On June 17, 2015, the Court issued a Temporary Restraining Order (TRO) enjoining the respondents from:
• Granting any pending applications for reproductive products including contraceptive drugs and devices.
• Procuring, selling, distributing, dispensing, advertising, and promoting “Implanon” and “Implanon NXT.”
• Petitioners filed a petition for contempt (G.R. No. 221866) alleging that the FDA, despite the TRO, continued to effectuate registration or re-certification actions.
• The petitioners further called upon the Court to use its rule-making power to require the FDA and DOH to institute procedures that ensure publication, public hearings, intervention by interested parties, and a resolution of doubts favoring the right to life of the unborn.

Issue:

Locus Standi and Proper Recourse

• Whether the petitioners, as citizens and taxpayers, have the legal standing to challenge the FDA’s and DOH’s actions on the grounds of constitutional rights.
• Whether their direct resort to the Court via petitions for certiorari, prohibition, mandamus, and contempt is proper given the concurrent jurisdiction with lower courts.

Violation of Due Process in the FDA’s Re-certification Process

• Whether the FDA’s issuance of re-certification certificates for contraceptive drugs (notably “Implanon” and “Implanon NXT”) without adequate notice, public hearing, and an opportunity for intervention violates the procedural due process guarantees.
• Whether the failure to observe the basic tenets of due process in administrative proceedings, as necessitated by both substantive and procedural requirements, renders the FDA’s actions null and void.

Compliance with the Court’s Prior Decision in Imbong

• Whether the FDA and DOH, by not amending the RH-IRR to expunge the unconstitutional provisions declared in Imbong, have contravened the Court’s judgment.
• Whether the continued use and distribution of products certified under the flawed process undermine the constitutional protection of the life of the unborn.

The Scope of the Judicial Review Over Administrative Actions

• Whether the Court’s power to review and invalidate administrative acts (including rule-making or procedural lapses) extends to the quasi-judicial functions of the FDA.
• Whether the administrative processes governing re-certification should incorporate the same standards of fairness as judicial proceedings.

The Petition for Contempt

• Whether the respondents’ actions post-TRO constitute contempt of Court in light of the alleged failure to comply with the TRO’s directives.
• Whether evidence exists to substantiate that the respondents continued to distribute or promote the contested contraceptive products in defiance of the TRO.

Ruling:

• (Subscriber-Only)

Ratio:

• (Subscriber-Only)

Emphasis on the Primacy of Due Process

• The Court reiterated that due process is a cardinal constitutional guarantee which applies equally in judicial and administrative proceedings.

• The lack of notice and public hearing in the FDA’s re-certification process undermines the fundamental fairness required by law.

Protection of the Life of the Unborn

• Given the constitutional right to life of the unborn, any uncertainty regarding the safety and non-abortifacient nature of contraceptive drugs must be resolved in favor of preserving life.
• The burden of proof lies with the proponent of the contraceptive’s safety and non-abortifacient character; any ambiguity should be resolved in favor of life.

Judicial Oversight Over Administrative Proceedings

• The decision affirms that the judicial review of administrative acts is warranted when such acts potentially infringe upon fundamental constitutional rights.
• The Court emphasized that even procedures performed by quasi-judicial bodies such as the FDA must comply with the basic tenets of due process.

Rule-Making Power of the Court

• The Court ably exercised its constitutional power to promulgate and modify rules of procedure to ensure the protection of constitutional rights.
• This power extends to ensuring that regulatory agencies such as the FDA and DOH integrate essential procedural safeguards in their operations.

Legal Precedents and Doctrines

• The ruling draws on established jurisprudence, including Ang Tibay v. CIR and principles from cases like David v. Arroyo and Ginete v. Court of Appeals, to highlight the necessity of procedural fairness.
• These precedents reinforce the view

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