G.R. No. 217872 and G.R. No. 221866, August 24, 2016
ALLIANCE FOR THE FAMILY FOUNDATION, PHILIPPINES, INC. (ALFI) AND ATTY. MARIA CONCEPCION S. NOCHE, IN HER OWN BEHALF AND AS PRESIDENT OF ALFI, JOSE S. SANDEJAS, ROSIE B. LUISTRO, ELENITA S.A. SANDEJAS, EMILY R. LAWS, EILEEN Z. ARANETA, SALVACION C. MONTIERO, MARIETTA C. GORREZ, ROLANDO M. BAUTISTA, RUBEN T. UMALI AND MILDRED C. CASTOR, PETITIONERS, VS. HON. JANETTE L. GARIN, SECRETARY-DESIGNATE OF THE DEPARTMENT OF HEALTH, NICOLAS B. LUTERO III, ASSISTANT SECRETARY OF HEALTH, OFFICER-IN-CHARGE, FOOD AND DRUG ADMINISTRATION, AND MARIA LOURDES C. SANTIAGO, OFFICER-IN-CHARGE, CENTER FOR DRUG REGULATION AND RESEARCH, RESPONDENTS.

FACTS

This case involves two consolidated petitions stemming from the Supreme Court’s decision in Imbong v. Ochoa, which declared the Reproductive Health (RH) Law constitutional except for several specific provisions. Petitioners, who were among those who opposed the RH Law, wrote to the Food and Drug Administration (FDA) inquiring about steps taken to implement the Court’s decision. In September 2014, petitioner Rosie B. Luistro saw an FDA Notice inviting Marketing Authorization Holders of fifty contraceptive drugs to apply for re-evaluation/re-certification. Petitioner ALFI, believing these contraceptives were abortifacients under the RH Law, filed a preliminary and later a main opposition to seventy-seven contraceptive drugs. Despite the pending opposition, the FDA issued certificates of product registration for “Implanon” and “Implanon NXT” on November 27, 2014. Petitioners’ subsequent letters to the DOH and FDA regarding the status of their opposition went unanswered. Petitioners filed a petition for certiorari, contending the FDA committed grave abuse of discretion by violating the Imbong decision, failing to act on their opposition, and violating due process due to a lack of procedure for re-evaluation. They also alleged the DOH had been administering Implanon and that the RH-IRR posted online still contained provisions declared unconstitutional. The Court issued a Temporary Restraining Order (TRO) on June 17, 2015, enjoining respondents from granting pending applications for reproductive products and from procuring, selling, distributing, etc., “Implanon” and “Implanon NXT.” Respondents, through the OSG, argued petitioners lacked standing, violated the hierarchy of courts, and that the FDA’s re-certification was a scientific and regulatory act not subject to certiorari. A separate Petition for Contempt (G.R. No. 221866) was filed, alleging respondents violated the TRO by issuing a certificate of product registration for another drug, “Lydia Post Pill,” and by continuing to promote and procure contraceptives.

ISSUE

The primary issue is whether the FDA and DOH committed grave abuse of discretion amounting to lack or excess of jurisdiction in the re-certification of contraceptive drugs and devices, and in their implementation of the RH Law post-Imbong.

RULING

The Supreme Court DISMISSED the petitions.
1. On the Petition for Certiorari ( G.R. No. 217872 ): The Court held that a petition for certiorari under Rule 65 was an improper remedy. The acts complained of—the FDA’s re-evaluation/re-certification of contraceptive drugs and the DOH’s procurement and distribution—were exercises of quasi-legislative or quasi-judicial functions. For quasi-legislative acts (rulemaking), certiorari is not available; the proper recourse is to question the reasonableness or constitutionality of the rules. For quasi-judicial acts (adjudication, like product registration), the proper remedy is an appeal to the Secretary of Health, as provided under the FDA Act of 2009, not a direct petition to the Supreme Court. The Court found that petitioners failed to exhaust this administrative remedy. Furthermore, the Court ruled that petitioners did not have legal standing. They failed to demonstrate a direct and personal injury; their interest was too generalized and based on a “mere expectancy” of a right. The issues raised were also not of transcendental importance to justify relaxing procedural rules, as the core policy question on contraceptive use had already been settled in Imbong. The Court also found no violation of the Imbong decision, as the FDA’s re-certification process was its mandate to ensure safety, and the decision did not prohibit the certification of contraceptives per se but only struck down specific provisions of the law and its IRR.
2. On the Petition for Contempt (G.R. No. 221866): The Court found no sufficient basis to hold respondents in contempt. The TRO specifically enjoined actions related to “Implanon” and “Implanon NXT” and pending applications. The issuance of a certificate for “Lydia Post Pill” was not covered by the TRO as it was not one of the drugs specifically named. The alleged continued promotion and procurement were based on news articles and hearsay, which were insufficient to prove contempt beyond reasonable doubt. The Court noted that the DOH had issued a memorandum to its units to comply with the TRO.
3. On the Prayer for the Court to Promulgate Rules: The Court declined the petitioners’ request to promulgate rules for the FDA’s re-certification process, stating that this is a function of the executive branch, not the judiciary. The Court’s rule-making power under the Constitution is limited to rules concerning pleading, practice, and procedure in courts.
The TRO issued on June 17, 2015, was LIFTED and SET ASIDE.