Compliance with the Supreme Court Resolution Regarding the Recertification and Certification of Contraceptive Products
On 26 April 2017, the Supreme Court (SC) issued a Resolution ordering the Food and Drug Administration (FDA) to consider “the oppositions filed by Alliance for the Family Foundation, Inc. (ALFI) with respect to the listed drugs, including Implanon and Implanon NXT, based on the standards of the Reproductive Health Law, as construed in Imbong vs. Ochoa, and to decide the case within sixty (60) days from the date it will be deemed submitted for resolution”.
Consequently, the FDA issued on 21 August 2017 Advisory No. 2017-253 to begin the recertification process for the listed products.
FDA wishes to advice the public that—
1) For the recertification process, the FDA will no longer issue any additional guidelines as the provisions in RA 10354 and its Implementing Rules and Regulations, and the decision of the High Court in ALFI vs. Garin et al. are already clear.
2) For the certification process of new reproductive health products, the draft of the revised IRR will contain the guidelines that will be implemented by the FDA in the registration process. As a matter of procedure, a public consultation will be scheduled and held to give opportunity to the public to comment on this.
The FDA is determined to do its part by exerting all efforts to consider the oppositions filed and decide on their merits accordingly.
The FDA is mindful of its responsibility to comply with the SC’s decision, and to uphold the mandates of due process, both geared towards the goal of ensuring and protecting public health.