Tag: Contraceptives

Due Process in Reproductive Health: FDA Must Hear Opposition to Contraceptives

The Supreme Court has affirmed that the Food and Drug Administration (FDA) must observe due process when certifying or re-certifying contraceptive drugs and devices. This means the FDA must provide notice and hearing to parties who oppose the approval of such products, particularly regarding concerns that they may be abortifacients. The ruling ensures that the FDA’s decisions are not made in a vacuum and that all voices are heard before potentially harmful products are made available to the public. This landmark decision underscores the importance of transparency and fairness in regulatory processes that impact public health and constitutional rights, ensuring that the FDA’s mandate does not override fundamental protections.

When Science Meets Due Process: Balancing Public Health and Individual Rights in Contraceptive Certification

The case of Alliance for the Family Foundation, Philippines, Inc. (ALFI) v. Hon. Janette L. Garin revolves around the FDA’s certification and re-certification of contraceptive drugs and devices, specifically Implanon and Implanon NXT. ALFI, along with concerned citizens, filed petitions questioning the FDA’s procedures, arguing that they were not given a fair opportunity to be heard regarding their concerns that these contraceptives could be abortifacients. This legal challenge highlights a fundamental tension: the government’s responsibility to ensure public access to reproductive health products versus its obligation to protect the constitutional rights of individuals and groups affected by those products.

At the heart of the controversy is the question of whether the FDA’s actions in certifying and re-certifying contraceptives are subject to judicial review, particularly when allegations of grave abuse of discretion are raised. The respondents, led by the Secretary of Health and FDA officials, argued that their actions were purely regulatory and administrative, thus exempting them from the due process requirements of notice and hearing. They contended that the issuance of a Certificate of Product Registration (CPR) did not involve adjudicating opposing rights and liabilities in an adversarial proceeding. The FDA further distinguished between its “quasi-judicial powers” and its “regulatory/administrative powers,” asserting that the CPR issuance falls under the latter and does not require notice and hearing.

The Supreme Court, however, firmly rejected this argument, emphasizing its power to review all acts and decisions of government instrumentalities where there is a commission of grave abuse of discretion. The Court stressed that this power is enshrined in the Constitution and cannot be curtailed by the FDA’s invocation of its regulatory authority. Grave abuse of discretion occurs when there is a violation of the constitutional mandate that “no person is deprived of life, liberty, and property without due process of law.”

“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 excess of jurisdiction is committed by any branch or instrumentality of the Government. Such is committed when there is a violation of the constitutional mandate that ‘no person is deprived of life, liberty, and property without due process of law.’”

The Court clarified the distinction between quasi-legislative and quasi-judicial powers of administrative bodies. While the exercise of quasi-legislative power generally does not require notice and hearing, the exercise of quasi-judicial power does. Quasi-judicial power involves determining questions of fact and applying legislative policy, requiring both jurisdiction and the observance of due process, including the right to notice and hearing. The Supreme Court has consistently exercised its power of judicial review over agencies exercising their regulatory powers, including the Department of Public Works and Highways (DPWH), Toll Regulatory Board (TRB), and Securities and Exchange Commission (SEC), among others.

The Court found that the petitioners were indeed denied their right to due process, as they were not given a genuine opportunity to be heard regarding their opposition to the contraceptive drugs and devices. The respondents failed to act upon or address the oppositions filed by the petitioners, instead relying on technical and procedural grounds to challenge the petitions. This, the Court held, violated the petitioners’ constitutional right to due process of law. The FDA’s outlined procedure for approving contraceptive drugs or devices, while including steps for notice and public comments, was deemed deficient. It only allowed public comments in cases of re-certification, not in cases where a drug or device was being certified for the first time, a clear contravention of the Court’s mandate in Imbong v. Ochoa.

The Court outlined in Ang Tibay v. CIR the cardinal rights of parties in administrative proceedings: the right to a hearing, consideration of evidence presented, a decision with supporting evidence, substantial evidence, a decision based on the record, independent consideration of law and facts, and a decision that informs parties of the issues and reasons for the decision. The Court found that the FDA failed to comply with these tenets by certifying, procuring, and administering contraceptive drugs without notice or public hearing. It reiterated its order to remand the case to the FDA to conduct a hearing.

However, the Court clarified that the FDA need not conduct a trial-type hearing. Due process does not require a formal trial; it is sufficient that the parties are given a fair and reasonable opportunity to explain their positions and present supporting evidence. The FDA must afford the people their right to due process and decide on applications after affording oppositors a genuine opportunity to present their science-based evidence.

In this context, “substantial evidence” refers to the best scientific evidence available, including meta-analyses, systematic reviews, national clinical practice guidelines, and recommendations of international medical organizations. The FDA is not bound by the evidence adduced by the parties alone but can conduct its own search for related scientific data and consult with technical scientific experts. The FDA is also not bound by the principle of stare decisis or res judicata but may update itself and cancel certifications motu proprio when new contrary scientific findings become available or there arise manifest risks.

Ultimately, the Court modified its original decision, ordering that any appeal from the FDA’s decision should be directed to the Office of the President, pursuant to Section 9 of Executive Order No. 247, rather than the Secretary of Health. The Supreme Court held that the issuance of the TRO did not mean that the FDA should stop fulfilling its mandate to test, analyze, scrutinize, and inspect other drugs and devices and reiterated its directive to the FDA to amend its IRR to align with the mandates in Imbong v. Ochoa.

FAQs

What was the key issue in this case?	The central question was whether the FDA violated due process by certifying or re-certifying contraceptive drugs without providing notice and a hearing to parties who opposed their approval.
What did the Supreme Court decide?	The Court ruled that the FDA must observe due process, including providing notice and a hearing to oppositors, when certifying or re-certifying contraceptive drugs and devices.
What does “due process” mean in this context?	In administrative proceedings, due process means giving interested parties a fair and reasonable opportunity to present their case and evidence before a decision is made.
Does this mean the FDA must conduct a full trial?	No, the Court clarified that a full trial is not required. The FDA needs to provide a reasonable opportunity for parties to present their arguments and evidence.
What kind of evidence should the FDA consider?	The FDA should consider the best scientific evidence available, including meta-analyses, systematic reviews, and recommendations from reputable medical organizations.
To whom should appeals from the FDA decision be directed?	Appeals should be directed to the Office of the President, rather than the Secretary of Health, according to Section 9 of Executive Order No. 247.
What are the implications of this ruling for the FDA?	The FDA must amend its procedures to ensure that oppositors are given a fair opportunity to be heard and their concerns are considered before contraceptive drugs are certified or re-certified.
Does this ruling affect the availability of contraceptives?	The ruling does not ban contraceptives but ensures a more transparent and participatory process for their approval.
Does this ruling only apply to contraceptives?	While the ruling specifically addresses contraceptives, its principles regarding due process in administrative proceedings can extend to other areas of regulation.

This decision underscores the delicate balance between ensuring public health and protecting individual rights. The Supreme Court’s ruling mandates that the FDA must adhere to due process requirements, providing a more transparent and participatory process for approving contraceptive drugs and devices. While the decision may introduce some delays in the certification process, it ultimately serves to strengthen public trust and ensure that regulatory decisions are made with full consideration of all relevant perspectives.

For inquiries regarding the application of this ruling to specific circumstances, please contact ASG Law through contact or via email at frontdesk@asglawpartners.com.

Disclaimer: This analysis is provided for informational purposes only and does not constitute legal advice. For specific legal guidance tailored to your situation, please consult with a qualified attorney.
Source: Alliance for the Family Foundation, Philippines, Inc. (ALFI) v. Hon. Janette L. Garin, G.R. No. 217872 & 221866, April 26, 2017

April 26, 2017

Due Process in Drug Certification: Protecting Rights in Reproductive Health Decisions

The Supreme Court ruled that the Food and Drug Administration (FDA) violated due process in certifying and distributing contraceptive drugs, including Implanon and Implanon NXT. The Court emphasized that while the FDA has the authority to determine the safety and non-abortifacient properties of drugs, it must provide notice and a fair hearing to those who oppose such certifications. This decision underscores the importance of procedural fairness in administrative decisions, especially when they touch on sensitive issues like reproductive health and the right to life.

FDA’s Oversight: Balancing Public Health and Due Process in Contraceptive Certification

This case stems from challenges to the implementation of the Reproductive Health Law (RH Law) in the Philippines. Petitioners, including Alliance for the Family Foundation, Philippines, Inc. (ALFI), questioned the FDA’s re-evaluation and re-certification of several contraceptive drugs, alleging that these drugs were potentially abortifacient. They contended that the FDA failed to observe due process by not providing adequate notice, hearing, or consideration of their opposition before issuing certifications for these drugs. The central legal question was whether the FDA’s actions violated the petitioners’ right to due process, particularly in light of constitutional concerns regarding the right to life of the unborn.

The petitioners argued that the FDA’s actions were conducted without proper procedure, rules, regulations, or consultations, thereby violating their right to due process. They specifically pointed to the issuance of certificates of product registration for Implanon and Implanon NXT shortly after a Senate committee required FDA certifications for contraceptives as a condition for government funding. Furthermore, they claimed that the Department of Health (DOH) had already begun administering Implanon even before the certificates were issued. The petitioners sought to enjoin the approval, procurement, distribution, administration, advertisement, and promotion of contraceptive use by the FDA and the DOH, asserting that these actions were tainted with grave abuse of discretion.

The respondents, through the Office of the Solicitor General (OSG), countered that the petitioners lacked the legal standing to file the petition and that their direct resort to the Supreme Court violated the doctrine of hierarchy of courts. The OSG also maintained that the re-certification of contraceptive drugs involved scientific determinations of fact within the FDA’s regulatory power, which did not require notice and hearing. They further argued that the FDA was guided by the RH-IRR and other administrative issuances in its re-certification process.

The Supreme Court, however, sided with the petitioners, holding that they had the legal standing to question the FDA’s actions, given the transcendental importance of the issues and the potential allocation of public funds for alleged abortifacients. The Court emphasized that the right to life of the unborn was a paramount concern, justifying the petitioners’ intervention. The Court rejected the argument that the FDA’s regulatory function was beyond judicial review, asserting its duty to determine whether there had been grave abuse of discretion on the part of any government instrumentality.

The Court underscored the importance of due process, both substantive and procedural, in administrative proceedings. Citing Ang Tibay v. CIR, the Court reiterated the cardinal rights of parties in administrative proceedings, including the right to a hearing, the consideration of evidence, and a decision supported by substantial evidence. The Court found that the FDA had failed to observe these basic tenets of due process by certifying, procuring, and administering contraceptive drugs without notice or public hearing, despite the petitioners’ opposition.

The Court also addressed the issue of the Temporary Restraining Order (TRO) it had previously issued, enjoining the respondents from granting applications for reproductive products and supplies and from procuring, selling, distributing, dispensing, administering, advertising, and promoting Implanon and Implanon NXT. While denying the motion to lift the TRO, the Court clarified that it was not restraining the FDA from carrying out its mandate to test, analyze, scrutinize, and inspect drugs and devices. Instead, the Court emphasized that the TRO was intended to prevent the grant of certifications/re-certifications without due process and the distribution and administration of questioned contraceptive drugs until they were determined to be safe and non-abortifacient.

In light of these considerations, the Supreme Court ordered the case remanded to the FDA, directing the agency to observe due process by conducting a hearing and allowing the petitioners to be heard on the re-certified, procured, and administered contraceptive drugs. The Court also directed the FDA to formulate rules of procedure in the screening, evaluation, and approval of all contraceptive drugs and devices, ensuring that these rules included minimum requirements of due process, such as publication, notice, hearing, and the consideration of evidence. The court also ordered the DOH to provide rules and regulations that ensures the drugs are not to be used as abortifacient. The Court ordered the respondents to amend the Implementing Rules and Regulations to conform to the rulings and guidelines in G.R. No. 204819 and related cases.

Furthermore, the Court clarified that any decision of the FDA is appealable to the Court of Appeals through a petition for review under Rule 43 of the Rules of Court. The Supreme Court acknowledged the inaction of the public respondents to amend the RH-IRR to conform to the pronouncements in Imbong, and the failure to provide a procedural mechanism by which oppositors may challenge the safety and the non-abortifacient character of contraceptive drugs and devices. As such, the Court adopted and embodied in the dispositive portion the instructions in the Concurring Opinion of Hon. Mariano C. Castillo in Imbong, to serve as guidelines for all concerned.

FAQs

What was the key issue in this case?	The key issue was whether the FDA violated due process in certifying and distributing contraceptive drugs without providing adequate notice and a hearing to those who opposed the certifications.
What did the Supreme Court rule?	The Supreme Court ruled that the FDA had indeed violated due process and ordered the case remanded to the FDA for further proceedings in compliance with due process requirements.
What is the significance of due process in this case?	Due process ensures fairness and transparency in administrative decisions, requiring that individuals have the opportunity to be heard and present their case before being deprived of their rights or interests.
What are the cardinal rights of parties in administrative proceedings?	The cardinal rights include the right to a hearing, the consideration of evidence, a decision supported by substantial evidence, and a decision rendered on the evidence presented at the hearing.
What is the FDA required to do as a result of this ruling?	The FDA is required to conduct a hearing on the re-certified contraceptive drugs and devices and formulate rules of procedure in the screening, evaluation, and approval of all contraceptive drugs and devices.
What is the effect of the Temporary Restraining Order (TRO)?	The TRO enjoins the respondents from granting applications for reproductive products and supplies and from procuring, selling, distributing, dispensing, administering, advertising, and promoting Implanon and Implanon NXT until further proceedings.
Can the FDA still carry out its mandate to test drugs and devices?	Yes, the Court clarified that the TRO does not restrain the FDA from testing, analyzing, scrutinizing, and inspecting drugs and devices.
What happens to decisions made by the FDA?	The Supreme Court clarified that the any adverse decision by the FDA in this particular case should be directly appealable to the Court of Appeals (CA) through a petition for review under Rule 43 of the Rules of Court.

This case highlights the critical balance between administrative efficiency and the protection of individual rights. While agencies like the FDA must be able to perform their regulatory functions effectively, they must also adhere to the principles of due process to ensure fairness and transparency in their decision-making processes. This ruling serves as a reminder that procedural safeguards are essential, especially in matters involving sensitive constitutional rights.

For inquiries regarding the application of this ruling to specific circumstances, please contact ASG Law through contact or via email at frontdesk@asglawpartners.com.

August 24, 2016