SPECIAL SECOND DIVISION where the Court resolved the: [1] Petition for Certiorari, Republic Act No.

e Court resolved the: [1] Petition for Certiorari, Republic Act No. 10354 covered by the certification from the Food
Prohibition, Mandamus with Prayer for Issuance of a Temporary and Drug Administration that said product and supply is made
April 26, 2017 Restraining Order and/or Writ of Preliminary Prohibitory and available on the condition that it will not be used as an
G.R. No. 217872 Mandatory Injunction (G.R. No. 217872); and the [2] Petition for abortifacient subject to the following minimum due process
Contempt of Court (G.R. No. 221866), in the following manner: requirements: (a) publication, notice and hearing, and (b)
interested parties shall be allowed to intervene. The rules and
regulations or guidelines shall provide sufficient detail as to the
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. WHEREFORE, the case docketed as G.R No. 217872 is hereby manner by which said product and supply shall be strictly regulated
SANDEJAS, ROSIE B. LUISTRO, ELENITA S.A. SANDEJAS, EMILY R. LAWS, EILEEN Z. REMANDED to the Food and Drugs Administration which is hereby in order that they will not be used as an abortifacient and in order
ARANETA, SALV ACION C. MONTEIRO, MARIETTA C. GORREZ, ROLANDO M. to sufficiently safeguard the right to life of the unborn.
BAUTISTA, RUBEN T. UMALI, and MILDRED C. CASTOR , Petitioners ordered to observe the basic requirements of due process by
conducting a hearing, and allowing the petitioners to be heard, on
vs. the re-certified, procured and administered contraceptive drugs
HON. JANETTE L. GARIN, Secretary-Designate of the Department of Health; NICOLAS and devices, including Implanon and lmplanon NXT, and to 3. DIRECTS the Department of Health to generate the complete and
B.LUTERO III, Assistant Secretary of Health, Officer-in-Charge, Food and Drug determine whether they are abortifacients or non-abortifacients. correct list of the government's reproductive health programs and
Administration; and MARIA LOURDES C. SANTIAGO, Officer in-Charge, Center for services under Republic Act No. 10354 which will serve as the
Drug Regulation and Research, Respondents
template for the complete and correct information standard and,
Pursuant to the expanded jurisdiction of this Court and its power to hence, the duty to inform under Section 23(a)(l) of Republic Act No.
issue rules for the protection and enforcement of constitutional 10354. The Department of Health is DIRECTED to distribute copies
x-----------------------x
rights, the Court hereby: of this template to all health care service providers covered by
Republic Act No. 10354.
G.R. No. 221866

1. DIRECTS the Food and Drug Administration to formulate the

rules of procedure in the screening, evaluation and approval of all The respondents are hereby also ordered to amend the
MARIA CONCEPCION S. NOCHE, in her own behalf and as counsel of Petitioners, JOSE
contraceptive drugs and devices that will be used under Republic Implementing Rules and Regulations to conform to the rulings and
S. SANDEJAS, ROSIE B. LUISTRO, ELENITA S.A. SANDEJAS, EMILY R. LAWS EILEEN Z.
Act No. 10354. The rules of procedure shall contain the following guidelines in G.R. No. 204819 and related cases.
ARANETA, SALVACION C. MONTEIRO MARIETTA C. GORREZ, ROLANDO M. BAUTISTA,
RUBEN T. UMALI, and MILDRED C. CASTOR, Petitioners minimum requirements of due process: (a) publication, notice and
vs.
hearing, (b) interested parties shall be allowed to intervene, (c) the
standard laid down in the Constitution, as adopted under Republic The above foregoing directives notwithstanding, within 30 days
HON. JANETTE L. GARIN, Secretary-Designate of the Department of Health; NICOLAS B. Act No. 10354, as to what constitutes allowable contraceptives from receipt of this disposition, the Food and Drugs Administration
LUTERO III, Assistant Secretary of Health; NICOLAS B. LUTERO III, Assistant Secretary of
Health, Officer-in-Charge, Food and Drug Administration; and MARIA LOURDES C.
shall be strictly followed, that is, those which do not harm or should commence to conduct the necessary hearing guided by the
SANTIAGO, Officer-in-Charge, Center for Drug Regulation and Research, Respondents. destroy the life of the unborn from conception/fertilization, (d) in cardinal rights of the parties laid down in CIR v. Ang Tibay.
weighing the evidence, all reasonable doubts shall be resolved in
favor of the protection and preservation of the right to life of the
RESOLUTION unborn from conception/fertilization, and (e) the other Pending the resolution of the controversy, the motion to lift the
requirements of administrative due process, as summarized in Ang Temporary Restraining Order is DENIED.
Tibay v. CIR, shall be complied with.
MENDOZA, J.:
With respect to the contempt petition, docketed as G.R No.
2. DIRECTS the Department of Health in coordination with other 221866, it is hereby DENIED for lack of concrete basis.
Subject of this resolution is the Omnibus Motion1 filed by the concerned agencies to formulate the rules and regulations or
respondents, thru the Office of the Solicitor General (OSG), seeking guidelines which will govern the purchase and distribution/
partial reconsideration of the August 24, 2016 Decision (Decision),2 dispensation of the products or supplies under Section 9 of
SO ORDERED.3
 that the Decision wreaked havoc on the organizational structure of
the FDA, whose myriad of functions had been carefully delineated
Arguments of the Respondents in the IRR of R.A. No. 9711. 11 The respondents, thus, prayed for Judicial Review
the lifting of the Temporary Restraining Order (TR0). 12

Part 1: Due Process need not be complied with as the questioned The powers of an administrative body are classified into two
acts of the Food and Drug Administration (FDA) were in the Part 2: The requirements of due process need not be complied with fundamental powers: quasi-legislative and quasi-judicial. Quasi-
exercise of its Regulatory Powers as the elements of procedural due process laid down in Ang Tibay legislative power, otherwise known as the power of subordinate
v. CIR are not applicable legislation, has been defined as the authority delegated by the
In the subject Omnibus Motion, the respondents argued that their lawmaking body to the administrative body to adopt rules and
actions should be sustained, even if the petitioners were not regulations intended to carry out the provisions of law and
afforded notice and hearing, because the contested acts of implement legislative policy. 18 "[A] legislative rule is in the nature
registering, re-certifying, procuring, and administering The respondents further claimed in their omnibus motion that the of subordinate legislation, designed to implement a primary
contraceptive drugs and devices were all done in the exercise of its requirements of due process need not be complied with because legislation by providing the details thereof." 19 The exercise by the
regulatory power.4 They contended that considering that the the standards of procedural due process laid down in Ang Tibay v. administrative body of its quasi-legislative power through the
issuance of the certificate of product registration (CPR) by the FDA CIR 13 were inapplicable considering that: a) substantial evidence promulgation of regulations of general application does not, as a
under Section 7.04, Rule5 of the Implementing Rules and could not be used as a measure in determining whether a rule, require notice and hearing. The only exception being where
Regulations of Republic Act (R.A.) No. 10354 (RH-IRR) did not contraceptive drug or device was abortifacient; 14 b) the courts the Legislature itself requires it and mandates that the regulation
involve the adjudication of the parties' opposing rights and had neither jurisdiction nor competence to review the findings of shall be based on certain facts as determined at an appropriate
liabilities through an adversarial proceeding, the due process the FDA on the non-abortifacient character of contraceptive drugs investigation.20
requirements of notice and hearing need not be complied with.6 or devices; 15 c) the FDA was not bound by the rules of
admissibility and presentation of evidence under the Rules of
Court; 16 and d) the findings of the FDA could not be subject of the
rule on res judicata and stare-decisis. 17 Quasi-judicial power, on the other hand, is known as the power of
Stated differently, the respondents assert that as long as the act of the administrative agency to determine questions of fact to which
the FDA is exercised pursuant to its regulatory power, it need not the legislative policy is to apply, in accordance with the standards
comply with the due process requirements of notice and hearing. laid down by the law itself.21 As it involves the exercise of
The respondents then insisted that Implanon and Implanon NXT discretion in determining the rights and liabilities of the parties, the
were not abortifacients and lamented that the continued injunction proper exercise of quasi-judicial power requires the concurrence of
Corollary to this, the respondents wanted the Court to consider of the Court had hampered the efforts of the FDA to provide for the two elements: one, jurisdiction which must be acquired by the
that the FDA had delineated its functions among different persons reproductive health needs of Filipino women. For the respondents, administrative body and two, the observance of the requirements
and bodies in its organization. Thus, they asked the Court to make a to require them to afford the parties like the petitioners an of due process, that is, the right to notice and hearing.22
distinction between the "quasi-judicial powers" exercised by the opportunity to question their findings would cause inordinate delay
Director-General of the FDA under Section 2(b)7 of Article 3, Book I in the distribution of the subject contraceptive drugs and devices
of the Implementing Rules and Regulations (IRR) of R.A. No. 9711,8 which would have a dire impact on the effective implementation of
the RH Law. On the argument that the certification proceedings were
and the "regulatory/administrative powers" exercised by the FDA conducted by the FDA in the exercise of its "regulatory powers"
under Section 2(c )(1) 9 of the same. For the respondents, the and, therefore, beyond judicial review, the Court holds that it has
distinction given in the above-cited provisions was all but proof the power to review all acts and decisions where there is a
that the issuance of CPR did not require notice and hearing. The Court's Ruling commission of grave abuse of discretion. No less than the
Constitution decrees that the Court must exercise its duty to
ensure that no grave abuse of discretion amounting to lack or
After detailing the process by which the FDA's Center for Drug After an assiduous assessment of the arguments of the parties, the excess of jurisdiction is committed by any branch or instrumentality
Regulation and Research (CDRR) examined and tested the Court denies the Omnibus Motion, but deems that a clarification on of the Government. Such is committed when there is a violation of
contraceptives for non-abortifacience, 10 the respondents stressed some points is in order. the constitutional mandate that "no person is deprived of life,
liberty, and property without due process of law." The Court's the twin requirements of notice and hearing. Nowhere from the of the questioned contraceptive drugs and devices. Instead of
power cannot be curtailed by the FDA's invocation of its regulatory above-quoted texts can it be inferred that the exercise of addressing the petitioners' assertion that the questioned
power. "regulatory power" places an administrative agency beyond the contraceptive drugs and devices fell within the definition of an
reach of judicial review. When there is grave abuse of discretion, "abortifacient" under Section 4(a) of the RH Law because of their
such as denying a party of his constitutional right to due process, "secondary mechanism of action which induces abortion or
In so arguing, the respondents cited Atty. Carlo L. Cruz in his book, the Court can come in and exercise its power of judicial review. It destruction of the fetus inside the mother's womb or the
Philippine Administrative Law. can review the challenged acts, whether exercised by the FDA in its prevention of the fertilized ovum to reach and be implanted in the
ministerial, quasi-judicial or regulatory power. In the past, the mother's womb,"32 the respondents chose to ignore them and
Court exercised its power of judicial review over acts and decisions proceeded with the registration, recertification, procurement, and
of agencies exercising their regulatory powers, such as DPWH, 24 distribution of several contraceptive drugs and devices.
Lest there be any inaccuracy, the relevant portions of the book TRB, 25 NEA, 26 and the SEC,27 among others. In Diocese of
cited by the respondents are hereby quoted as follows: Bacolod v. Commission on Elections,28 the Court properly
xxx. exercised its power of judicial review over a Comelec resolution A cursory reading of the subject Omnibus Motion shows that the
issued in the exercise of its regulatory power. respondents proffer no cogent explanation as to why they did not
act on the petitioners' opposition. As stated by the Court in the
B. The Quasi-Judicial Power Decision, rather than provide concrete action to meet the
Clearly, the argument of the FDA is flawed. petitioners' opposition, the respondents simply relied on their
xxx challenge questioning the propriety of the subject petition on
Petitioners were Denied their technical and procedural grounds. 33 The Court, thus, finds the
2. Determinative Powers subject motion to be simply a rehash of the earlier arguments
Right to Due Process
presented before, with the respondents still harping on the
To better enable the administrative body to exercise its quasi
peculiarity of the FDA's functions to exempt it from compliance
judicial authority, it is also vested with what is known as
with the constitutional mandate that "no person shall be deprived
determinative powers and functions. Due process of law has two aspects: substantive and procedural. In oflife, liberty and property without due process of law."
order that a particular act may not be impugned as violative of the
due process clause, there must be compliance with both the
Professor Freund classifies them generally into the enabling powers substantive and the procedural requirements thereof. 29
Substantive due process refers to the intrinsic validity of a law that The law and the rules demand compliance with due process
and the directing powers. The latter includes the dispensing, the
interferes with the rights of a person to his property.30 Procedural requirements
examining, and the summary powers.
due process, on the other hand, means compliance with the A reading of the various provisions, cited by the respondents in
procedures or steps, even periods, prescribed by the statute, in support of their assertion that due process need not be complied
conformity with the standard of fair play and without arbitrariness with in the approval of contraceptive drugs or devices, all the more
The enabling vowers are those that permit the doing of an act
on the part of those who are called upon to administer it.31 reinforces the Court's conclusion that the FDA did fail to afford the
which the law undertakes to regulate and which would be unlawful
with government approval. The most common example is the petitioners a genuine opportunity to be heard.
issuance of licenses to engage in a particular business or
occupation, like the operation of a liquor store or restaurant. x x x. The undisputed fact is that the petitioners were deprived of their
23 [Emphases and underscoring supplied] constitutional right to due process of law. As outlined by the respondents themselves, the steps by which the
FDA approves contraceptive drugs or devices, demand compliance
with the requirements of due process viz:
From the above, two things are apparent: one, the "enabling As expounded by the Court, what it found to be primarily
powers" cover "regulatory powers" as defined by the respondents; deplorable is the failure of the respondents to act upon, much less
and two, they refer to a subcategory of a quasi-judicial power address, the various oppositions filed by the petitioners against the Step 1. Identify contraceptive products in the database. Create
which, as explained in the Decision, requires the compliance with product registration, recertification, procurement, and distribution another database containing the following details of contraceptive
products: generic name, dosage strength and form, brand name (if A. Part I (Review of Chemistry, Manufacture and Controls)
any), registration number, manufacturer, MAH, and the period of
validity of the CPR. 1. Unit Dose and Finished Product Formulation 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,
2. Technical Finished Product Specifications based on the pronouncements of the Court in Im bong or any other
3. Certificate of Analysis law or rule, the FDA is duty-bound to take into account and
Step 2. Identify contraceptive products which are classified as consider the basis of the opposition.
essential medicines in the Philippine Drug Formulary.

B. Part II (Evaluation of Whether the Contraceptive Product is

Abortifacient) To conclude that product registration, recertification, procurement,
Step 3. Retrieve the contraceptive product's file and the CPR and distribution of the questioned contraceptive drugs and devices
duplicate of all registered contraceptive products. Create a 1. Evaluation of the scientific evidence submitted by the applicant by the FDA in the exercise of its regulatory power need not comply
database of the contraceptive product's history, including its initial, and the public. with the requirements of due process would render the issuance of
renewal, amendment, and/or variation applications. notices to concerned MAHs and the posting of a list of
2. Review and evaluation of extraneous evidence, e.g., scientific contraceptives for public comment a meaningless exercise.
journals, meta-analyses, etc. Concerned MAHs and the public in general will be deprived of any
Step 4. Conduct a preliminary review of the following: significant participation if what they will submit will not be
considered.
Step 8. Assess and review the documentary requirements
a. general physiology of female reproductive system, including submitted by the applicant. Technical reviewers considered
hormones involved, female reproductive cycle, and conditions of scientific evidence such as meta-analyses, systemic reviews, Section 7.04, Rule 7 of the IRR of the RH Law (RH-IRR),35 relied
the female reproductive system during pregnancy. national and clinical practice guidelines and recommendations of upon by the respondents in support of their claims, expressly
international medical organizations submitted by the companies, allows the consideration of conflicting evidence, such as that
b. classification of hormonal contraceptives; organizations and individuals, to be part of the review.34 supplied by the petitioners in support of their opposition to the
[Emphases and Underlining supplied] approval of certain contraceptive drugs and devices. In fact, the
c. regulatory status of the products in benchmark countries; and
said provision mandates that the FDA utilize the "best evidence
d. mechanism of action of hormonal contraceptives based on available" to ensure that no bortifacient is approved as a family
reputable journals, meta-analyses, systemic reviews, evaluation of The Court notes that the above-outlined procedure is deficient planning drug or device. It bears mentioning that the same
regulatory authorities in other countries, textbooks, among others. insofar as it only allows public comments to cases of re- provision even allows an independent evidence review group (ERG)
certification. It fails to allow the public to comment in cases where to ensure that evidence for or against the certification of a
a reproductive drug or device is being subject to the certification contraceptive drug or device is duly considered.
Step 5. Issue a notice to all concerned MAHs, requiring them to process for the first time. This is clearly in contravention of the
submit scientific evidence that their product is non-abortifacient, as mandate of the Court in lmbong that the IRR should be amended to
defined in the RH Law and Imbong. conform to it. Structure of the FDA

Step 6. Post a list of contraceptive products which were applied for More importantly, the Court notes that Step 5 requires the FDA to As earlier mentioned, the respondents argue that the Decision
re-certification for public comments in the FDA website. issue a notice to all concerned MAHs and require them to submit "wreaked havoc on the organizational structure of the FDA, whose
scientific evidence that their product is non-abortifacient; and that myriad of functions have been carefully delineated under R.A. No.
Step 6 requires the posting of the list of contraceptive products 9711 IRR."36 Citing Section 7.04, Rule 7 of the RH-IRR, the FDA
which were applied for re-certification for public comments in the insists that the function it exercises in certifying family planning
Step 7. Evaluate contraceptive products for re-certification. FDA website. 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 "(e) To issue certificates of compliance with technical requirements "(o) To prescribe standards, guidelines, and regulations with
Article 3, Book I of the RH-IRR.37 to serve as basis for the issuance of appropriate authorization and respect to information, advertisements and other marketing
spot-check for compliance with regulations regarding operation of instruments and promotion, sponsorship, and other marketing
manufacturers, importers, exporters, distributors, wholesalers, activities about the health products as covered in this Act;
The FDA wants the Court to consider that, as a body, it has a drug outlets, and other establishments and facilities of health
products, as determined by the FDA; "(p) To maintain bonded warehouses and/or establish the same,
distinct and separate personality from the Director-General, who whenever necessary or appropriate, as determined by the director-
exercises quasi-judicial power. The Court cannot accommodate the "xxx general for confiscated goods in strategic areas of the country
position of the respondents. Section 6(a) of R.A. No. 3720, as especially at major ports of entry; and
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, xxx." How can the head be separated from the "(h) To conduct appropriate tests on all applicable health products
body? prior to the issuance of appropriate authorizations to ensure "(q) To exercise such other powers and perform such other
safety, efficacy, purity, and quality; functions as may be necessary to carry out its duties and
responsibilities under this Act. [Emphases supplied]
"(i) To require all manufacturers, traders, distributors, importers,
For the record, Section 4 of R.A. No. 3720, as amended by Section 5 exporters, wholesalers, retailers, consumers, and non-consumer
of R.A. No. 9711, also recognizes compliance with the requirements users of health products to report to the FDA any incident that
of due process, although the proceedings are not adversarial. Thus: reasonably indicates that said product has caused or contributed to The Cardinal Rights of Parties in Administrative Proceedings as laid
the death, serious illness or serious injury to a consumer, a patient, down in Ang Tibay v. CIR
or any person;
Section 5. Section 4 of Republic Act No. 3720, as amended, is "G) To issue cease and desist orders motu propio or upon verified
hereby further amended to read as follows: In Ang Tibay v. CJR,39 the Court laid down the cardinal rights of
com plaint for health products, whether or not registered with the parties in administrative proceedings, as follows:
FDA Provided, That for registered health products, the cease and
desist order is valid for thirty (30) days and may be extended for
"SEC. 4. To carry out the provisions of this Act, there is hereby sixty (60) days only after due process has been observed;
created an office to be called the Food and Drug Administration 1) The right to a hearing, which includes the right to present one's
(FDA) in the Department of Health (DOH). Said Administration shall "(k) After due process, to order the ban, recall, and/or withdrawal case and submit evidence in support thereof;
be under the Office of the Secretary and shall have the following of any health product found to have caused the death, serious
illness or serious injury to a consumer or patient, or is found to be 2) The tribunal must consider the evidence presented;
functions, powers and duties:
imminently injurious, unsafe, dangerous, or grossly deceptive, and 3) The decision must have something to support itself;
to require all concerned to implement the risk management plan
which is a requirement for the issuance of the appropriate 4) The evidence must be substantial;
"(a) To administer the effective implementation of this Act and of authorization;
the rules and regulations issued pursuant to the same; 5) The decision must be rendered on the evidence presented at the
"(l) To strengthen the post market surveillance system in hearing, or at least contained in the record and disclosed to the
"(b) To assume primary jurisdiction in the collection of samples of monitoring health products as defined in this Act and incidents of parties affected;
health products; adverse events involving such products;
6) The tribunal or body or any of its judges must act on its or his
"(c) To analyze and inspect health products in connection with the "(m) To develop and issue standards and appropriate own independent consideration of the law and facts of the
implementation of this Act; authorizations that would cover establishments, facilities and controversy and not simply accept the views of a subordinate in
"(d) To establish analytical data to serve as basis for the health products; arriving at a decision; and
preparation of health products standards, and to recommend "(n) To conduct, supervise, monitor and audit research studies on 7) The board or body should, in all controversial questions, render
standards of identity, purity, safety, efficacy, quality and fill of health and safety issues of health products undertaken by entities its decision in such a manner that the parties to the proceeding can
container; duly approved by the FDA;
know the various issues involved, and the reason for the decision questioned contraceptive drugs by the respondents should be
rendered. 40 struck down as violative of the constitutional right to due process.
In the fairly recent case of Vivo v. Pagcor,43 the Court explained:

In the Decision, the Court found that the FDA certified, procured Verily, it is a cardinal precept that where there is a violation of basic
and administered contraceptive drugs and devices, without the constitutional rights, the courts are ousted from their jurisdiction. The observance of fairness in the conduct of any investigation is at
observance of the basic tenets of due process, that is, without The violation of a party's right to due process raises a serious the very heart of procedural due process. The essence of due
notice and without public hearing. It appeared that, other than the jurisdictional issue which cannot be glossed over or disregarded at process is to be heard, and, as applied to administrative
notice inviting stakeholders to apply for certification/recertification will. Where the denial of the fundamental right to due process is proceedings, this means a fair and reasonable opportunity to
of their reproductive health products, there was no showing that apparent, a decision rendered in disregard of that right is void for explain one's side, or an opportunity to seek a reconsideration of
the respondents considered the opposition of the petitioners. Thus, lack of jurisdiction. This rule is equally true in quasi-judicial and the action or ruling complained of. Administrative due process
the Court wrote: administrative proceedings, for the constitutional guarantee that cannot be fully equated with due process in its strict judicial sense,
no man shall be deprived of life, liberty, or property without due for in the former a formal or trial-type hearing is not always
process is unqualified by the type of proceedings (whether judicial necessary, and technical rules of procedure are not strictly applied.
or administrative) where he stands to lose the same.41 Ledesma v. Court of Appeals elaborates on the well-established
Rather than provide concrete evidence to meet the petitioners' meaning of due process in administrative proceedings in this wise:
opposition, the respondents simply relied on their challenge
questioning the propriety of the subject petition on technical and
procedural grounds. The Court notes that even the letters The Court stands by that finding and, accordingly, reiterates its
submitted by the petitioners to the FDA and the DOH seeking order of remand of the case to the FDA. x x x Due process, as a constitutional precept, does not always and
information on the actions taken by the agencies regarding their in all situations require a trial-type proceeding. Due process is
opposition were left unanswered as if they did not exist at all. The satisfied when a person is notified of the charge against him and
mere fact that the RH Law was declared as not unconstitutional given an opportunity to explain or defend himself. In administrative
Procedure in the FDA; No Trial-Type Hearing proceedings, the filing of charges and giving reasonable
does not permit the respondents to run roughshod over the
constitutional rights, substantive and procedural, of the petitioners. opportunity for the person so charged to answer the accusations
against him constitute the minimum requirements of due process.
The Court is of the view that the FDA need not conduct a trial-type The essence of due process is simply to be heard, or as applied to
hearing. Indeed, due process does not require the conduct of a administrative proceedings, an opportunity to explain one's side, or
Indeed, although the law tasks the FDA as the primary agency to trial-type hearing to satisfy its requirements. All that the an opportunity to seek a reconsideration of the action or ruling
determine whether a contraceptive drug or certain device has no Constitution requires is that the FDA afford the people their right to complained of. [Emphasis supplied; citations omitted]
abortifacient effects, its findings and conclusion should be allowed due process of law and decide on the applications submitted by
to be questioned and those who oppose the same must be given a MAHs after affording the oppositors like the petitioners a genuine
genuine opportunity to be heard in their stance. After all, under opportunity to present their science-based evidence. As earlier
Section 4(k) of R.A. No. 3720, as amended by R.A. No. 9711, the Best Evidence Available
pointed out, this the FDA failed to do. It simply ignored the
FDA is mandated to order the ban, recall and/ or withdrawal of any opposition of the petitioners. In the case of Perez, et al. v.
health product found to have caused death, serious illness or Philippine Telegraph and Telephone Company, et al., 42 it was
serious injury to a consumer or patient, or found to be imminently stated that: Section 5, Rule 133 of the Rules of Court provides:
injurious, unsafe, dangerous, or grossly deceptive, after due
process.

A formal trial-type hearing is not even essential to due process. It is Section 5. In all cases filed before administrative or quasi-
enough that the parties are given a fair and reasonable opportunity judicialbodies, a fact may be deemed established if it is supported
Due to the failure of the respondents to observe and comply with to explain their respective sides of the controversy and to present by substantialevidence, or the amount of relevant evidence which a
the basic requirements of due process, the Court is of the view that supporting evidence on which a fair decision can be based. reasonable mind might accept as adequate to justify a conclusion.
the certifications/re-certifications and the distribution of the
As applied to certification proceedings at the FDA, "substantial requires is that the FDA afford the people their right to due process
evidence" refers to the best scientific evidence available,44 of law and decide on the applications submitted by the MAHs after
"including but not limited to: meta analyses, systematic reviews, affording the oppositors, like the petitioners, a genuine opportunity On the Prayer to Lift the TRO
national clinical practice guidelines where available, and to present their sciencebased evidence.
recommendations of international medical organizations," needed
to support a conclusion whether a contraceptive drug or device is The respondents lament that the assailed decision undermines the
an abortifacient or not. The FDA need not be bound or limited by The Appellate Procedure; functions of the FDA as the specialized agency tasked to determine
the evidence adduced by the parties, but it can conduct its own whether a contraceptive drug or device is safe, effective and non-
search for related scientific data. It can also consult other technical Appeal to the Office of the President abortifacient. They also claim that the assailed decision requiring
scientific experts known in their fields. It is also not bound by the notice and hearing would unduly delay the issuance of CPR thereby
principle of stare decisis or res judicata, but may update itself and affecting public access to State-funded contraceptives. Finally, in a
cancel certifications motu proprio when new contrary scientific Incidentally, Section 32 of R.A. No. 3720 and Section 9 of Executive veritable attempt to sow panic, the respondents claim that the TRO
findings become available or there arise manifest risks which have Order (E.O.) No. 247 provide that any decision by the FDA would issued by the Court would result in "a nationwide stockout of
not been earlier predicted. then be appealable to the Secretary of Health, whose decision, in family planning supplies in accredited public health facilities and
tum, may be appealed to the Office of the President (OP). Thus: the commercial market. "45

On the Competence of the Court

Sec. 32. The orders, rulings or decisions of the FDA shall be On this score, it should be clarified that the Decision simply
to review the Findings of the FDA enjoined the respondents from registering, recertifying, procuring,
appealable to the Secretary of Health. - An appeal shall be deemed
perfected upon filing of the notice of appeal and posting of the and administering only those contraceptive drugs and devices
corresponding appeal bond. which were the subjects of the petitioners' opposition, specifically
The fact that any appeal to the courts will involve scientific matters Implanon and Implanon NXT. It never meant to enjoin the
will neither place the actions of the respondents beyond the need processing of the entire gamut of family planning supplies that
to comply with the requirements of Ang Tibay nor place the actions have been declared as unquestionably non-abortifacient.
of the FDA in certification proceedings beyond judicial review. An appeal shall not stay the decision appealed from unless an order Moreover, the injunction issued by the Court was only subject to
from the Secretary of Health is issued to stay the execution thereof. the condition that the respondents afford the petitioners a genuine
opportunity to their right to due process.
It should be pointed out that nowhere in Batas Pambansa Blg. 129,
as amended, are the courts ousted of their jurisdiction whenever Sec. 9. Appeals. - Decisions of the Secretary (DENR, DA, DOH or
the issues involve questions of scientific nature. A court is not DOST) may be appealed to the Office of the President. Recourse to As the Decision explained, the Court cannot lift the TRO prior to the
considered incompetent either in reviewing the findings of the FDA the courts shall be allowed after exhaustion of all administrative summary hearing to be conducted by the FDA. To do so would
simply because it will be weighing the scientific evidence presented remedies. render the summary hearing an exercise in futility. Specifically, the
by both the FDA and its oppositors in determining whether the respondents would want the Court to consider their argument that
contraceptive drug or device has complied with the requirements Implanon and Implanon NXT have no abortifacient effects.
of the law. In view thereof, the Court should modify that part of the Decision According to them, "the FDA tested these devices for safety,
which allows direct appeal of the FDA decision to the Court of efficacy, purity, quality, and non-abortiveness prior to the issuance
Appeals.1âwphi1 As stated in the said decision, the FDA decision of certificates of registration and recertification, and after the
Although the FDA is not strictly bound by the technical rules on need not be appealed to the Secretary of Health because she promulgation of Imbong." 46 The Court, however, cannot make
evidence, as stated in the Rules of Court, or it cannot be bound by herself is a party herein. Considering that the Executive such determination or pronouncement at this time. To grant its
the principle of stare decisis or res judicata, it is not excused from prayer to lift the TRO would be premature and presumptuous. Any
complying with the requirements of due process. To reiterate for declaration by the Court at this time would have no basis because
emphasis, due process does not require that the FDA conduct trial- the FDA, which has the mandate and expertise on the matter, has
Secretary is not a party herein, the appeal should be to the OP as
type hearing to satisfy its requirements. All that the Constitution to first resolve the controversy pending before its office.
provided in Section 9.
 adduced to convince the FDA unless they want to present JOSE CATRAL MENDOZA,
additional evidence to fortify their positions. The only entities that
This Court also explained in the Decision that the issuance of the would present evidence would be the petitioners to make their Associate Justice
TRO did not mean that the FDA should stop fulfilling its mandate to point by proving with relevant scientific evidence that the
test, analyze, scrutinize, and inspect other drugs and devices. Thus: contraceptives have abortifacient effects. Thereafter, the FDA can
resolve the controversy. WE CONCUR:

Nothing in this resolution, however, should be construed as

restraining or stopping the FDA from carrying on its mandate and Indeed, in addition to guaranteeing that no person shall be ANTONIO T. CARPIO
duty to test, analyze, scrutinize, and inspect drugs and devices. deprived of life, liberty and property without due process of law,48
What are being enjoined are the grant of certifications/re- the Constitution commands that "all persons shall have the right to Associate Justice
certifications of contraceptive drugs without affording the a speedy disposition of their cases before all judicial, quasi-judicial
petitioners due process, and the distribution and administration of Chairperson
and administrative bodies."49
the questioned contraceptive drugs and devices including Implanon
and Implanon NXT until they are determined to be safe and non-
abortifacient.47 MARIANO C. DEL CASTILLO
WHEREFORE, the August 24, 2016 Decision is MODIFIED.
Accordingly, the Food and Drug Administration is ordered to Associate Justice I Concur, see separate opinion
consider the oppositions filed by the petitioners with respect to the
On Delay listed drugs, including Implanon and Implanon NXT, based on the MARVIC M.V.F. LEONEN
standards of the Reproductive Health Law, as construed in lmbong
Associate Justice
v. Ochoa, and to decide the case within sixty (60) days from the
The respondents claim that this judicial review of the date it will be deemed submitted for resolution. SAMUEL R. MARTIRES
administrative decision of the FDA in certifying and recertifying
drugs has caused much delay in the distribution of the subject Associate Justice
drugs with a dire impact on the effective implementation of the RH After compliance with due process and upon promulgation of the
Law. decision of the Food and Drug Administration, the Temporary
Restraining Order would be deemed lifted if the questioned drugs ATTESTATION
and devices are found not abortifacients.
In this regard, the respondents have only themselves to blame.
Instead of complying with the orders of the Court as stated in the I attest that the conclusions in the above Resolution had been
Decision to conduct a summary hearing, the respondents have After the final resolution by the Food and Drug Administration, any reached in consultation before the case was assigned to the writer
returned to this Court, asking the Court to reconsider the said appeal should be to the Office of the President pursuant to Section of the opinion of the Court’s Division.
decision claiming that it has wreaked havoc on the organizational 9 of E.O. No. 247.
structure of the FDA.
As ordered in the August 24, 2016 Decision, the Food and Drug
ANTONIO T. CARPIO
Administration is directed to amend the Implementing Rules and
Had the FDA immediately conducted a summary hearing, by this Regulations of R.A. No. 10354 so that it would be strictly compliant Associate Justice
time it would have finished it and resolved the opposition of the with the mandates of the Court in lmbong v. Ochoa.
Chairperson, Second Division
petitioners.1âwphi1 Note that there was already a finding by the
FDA, which was its basis in registering, certifying and recertifying
the questioned drugs and devices. The pharmaceutical companies SO ORDERED.
or the MAHs need not present the same evidence it earlier CERTIFICATION
 b) The following mechanisms do not constitute abortion: the prevention of ovulation;
the direct action on sperm cells prior to fertilization; the thickening of cervical mucus;
and any mechanism acting exclusively prior to the fertilization of the egg by the sperm; Step 2. Identify contraceptive products which are classified as essential medicines in
Pursuant to the Section 13, Article VIII of the Constitution and the
the Philippine Drug Formulary.
Division Chairperson’s Attestation, I certify that the conclusions in
the above Resolution had been reached in consultation before the
c) In making its determination, the FDA shall use the best evidence available, including
case was assigned to the writer of the opinion of the Court’s Step 3. Retrieve the contraceptive product's file and the CPR duplicate of all registered
but not limited to: metaanalyses, systematic reviews, national clinical practice
Division. guidelines where available, and recommendations of international medical contraceptive products. Create a database of the contraceptive product's history,
organizations including its initial, renewal, amendment, and/or variation applications.

MARIA LOURDES P.A. SERENO

d) In the presence of conflicting evidence, the more recent, better-designed, and larger Step 4. Conduct a preliminary review of the following:
studies shall be preferred, and the conclusions found therein shall be used to
Chief Justice
determine whether or not a drug or device is an abortifacient; and

a. general physiology of female reproductive system, including hormones involved,

female reproductive cycle, and conditions of the female reproductive system during
e) Should the FDA require additional expertise in making its determination, an pregnancy.
independent evidence review group (ERG) composed of leading experts in the fields of
Footnotes pharmacodynamics, medical research, evidence-based medicine, and other relevant
fields may be convened to review the available evidence. The FDA shall then issue its
b. classification of hormonal contraceptives;
certification based on the recommendations of the ERG.

1 Rollo, pp. 406-744.

c. regulatory status of the products in benchmark countries; and

6 Rollo, pp. 414-416.

2 Id. at 382-405.

d. mechanism of action of hormonal contraceptives based on reputable journals,

7 Sec. 2. Duties and Functions of the Director-General x x x
meta-analyses, systemic reviews, evaluation of regulatory authorities in other
3 Id. at 402-403. countries, textbooks, among others.

b. Quasi-Judicial Powers, Duties and Functions:

4 Id. at 414-430. Step 5. Issue a notice to all concerned MAHs, requiring them to submit scientific
evidence that their product is non-abortifacient, as defined in the RH Law and lmbong.
xxx

5 Section 7.04. FDA Certification of Family Planning Supplies.

Step 6. Post a list of contraceptive products which were applied for re-certification for
8 Otherwise known as the Food and Drug Administration Act of2009. public comments in the FDA website.

The FDA must certify that a family planning drug or device is not an abortifacient in
dosages of its approved indication (for drugs) or intended use (for devices) prior to its
inclusion in the EDL. The FDA shall observe the following guidelines in the 9 c. Regulatory Powers, Duties and Functions: Step 7. Evaluate contraceptive products for re-certification.
determination of whether or not a drug or device is an abortifacient:

xxx A. Part I (Review of Chemistry, Manufacture and Controls)

a) As defined in Section 3.01 (a) of these Rules, a drug or device is deemed to be an
abortifacient if it is provento primarily induce abortion or the destruction of a fetus
inside the mother's womb or the prevention of the fertilized ovum to reach and be
10 Step 1. Identify contraceptive products in the database. Create another database 1. Unit Dose and Finished Product Formulation
implanted in the mother's womb;
containing the following details of contraceptive products: generic name, dosage
strength and form, brand name (if any), registration number, manufacturer, MAH, and
the period of validity of the CPR.
2. Technical Finished Product Specifications
 19 Commissioner of Customs v. Hypermix Feeds Corporation, 680 Phil. 681, 689 33 Decision, p. 15.
(2012), citing Misamis Oriental Association of Coco Traders, Inc. v. Department of
3. Certificate of Analysis Finance Secretary, G.R. No. 108524, November 10, 1994, 238 SCRA 63, 69-70.

34 Rollo, pp. 418-419.

B. Part II (Evaluation of Whether the Contraceptive Product is Abortifacient) 20 Cruz, Philippine Administrative Law, supra note 18 at 67.

35 Section 7.04. FDA Certification of Family Planning Supplies.

1. Evaluation of the scientific evidence submitted by the applicant and the public. 21 Id. at 88, citing Gudmindson v. Cardollo, 126 F2d. 521.

The FDA must certify that a family planning drug or device is not an abortifacient in
dosages of its approved indication (for drugs) or intended use (for devices) prior to its
2. Review and evaluation of extraneous evidence, e.g., scientific journals, meta- 22 Id. at 91. inclusion in the EDL. The FDA shall observe the following guidelines in the
analyses, etc. determination of whether or not a drug or device is an abortifacient:

23 Cruz, Philippine Administrative Law, supra note 18 at 41.

Step 8. Assess and review the documentary requirements submitted by the applicant. a) As define in Section 3.01 (a) of these Rules, a drug or device is deemed to be an
Technical reviewers considered scientific evidence such as meta-analyses, systemic abortifacient if it is proven to primarily induce abortion or the destruction of a fetus
reviews, national and clinical practice guidelines and recommendations of inside the mother's womb or the prevention of the fertilized ovum to reach and be
international medical organizations submitted by the companies, organizations and 24 Mirasol et al. v. DPWH and TRB, 523 Phil. 713, (2006). implanted in the mother's womb;
individuals to be part of the review. [Emphases and Underling supplied]

25 Id. b) The following mechanisms do not constitute abortion: the prevention of ovulation;
11 Omnibus Motion, p. 37. the direct action on sperm cells prior to fertilization; the thickening of cervical mucus;
and any mechanism acting exclusively prior to the fertilization of the egg by the sperm;
26 ZAMECO II Board of Directors v. Castillejos Consumers Ass 'n. Inc. (CASCONA), et al.,
12 Rollo, pp. 442-447. 600 Phil. 365, (2009).
c) In making its determination, the FDA shall use the best evidence available, including
but not limited to: meta-analyses, systematic reviews, national clinical practice
guidelines where available, and recommendations of international medical
13 69 Phil. 635 (1940). 27 SEC v. Court of Appeals, 316 Phil. 903 (1995).
organizations;

14 Rollo, pp. 430-431. 28 G.R. No. 205728, January 21, 2015, 747 SCRA I. ("This case pertains to acts of
d) In the presence of conflicting evidence, the more recent, better-designed, and larger
COMELEC in the implementation of its regulatory powers. When it issued the notice
studies shall be preferred, and the conclusions found therein shall be used to
and letter, the COMELEC was allegedly enforcing election laws.")
determine whether or not a drug or device is an abortifacient; and
15 Id. at 431-432, 442.

29 Republic of the Phils. v. Sandiganbayan, 461 Phil. 598 (2003).

e) Should the FDA require additional expertise in making its determination, an
16 Id. at 432-433. independent evidence review group (ERG) composed of leading experts in the fields of
pharmacodynamics, medical research, evidence-based medicine, and other relevant
30 Ynot v. Intermediate Appellate Court, No. L-74457, March 20, 1987, 148 SCRA 659. fields may be convened to review the available evidence. The FDA shall then issue its
certification based on the recommendations of the ERG.
17 Id. at 433-434.

31 Tatadv. Sandiganbayan, 242 Phil. 563, 575-576 (1988).

36 Omnibus Motion, p. 37.
18 Cruz, Philippine Administrative Law, p. 29 (2007 Edition).

32 Rollo (G.R. No. 217872), p. 18.

37 Id. at 10.
38 Dated August 18, 2009.

39 69 Phil. 635, 642-644 (1940).

40 As cited and paraphrased in Solid Homes v. Laserna, 574 Phil. 69, 83 (2008).

41 Rollo, pp. 396-397.

42 602 Phil. 522, 540 (2009).

43 721 Phil. 34, 39-40(2013).

44 See Section 7.04 (c) Rule 7 ofthe Implementing Rules and Regulations of R.A. No.
10354.

45 Rollo, pp. 442-446.

46 Omnibus Motion, pp. 40-41.

47 Alliance for the Family Foundation, Philippines, Inc. v. Garin, G.R. Nos. 217872 &
221866, August 24, 2016.

48 CONSTITUTION, (I 987), Art. III, Sec. I.

49 CONSTITUTION, (1987), Art. III, Sec. 16.