• FDA to start hearings on contraceptives


    The Food and Drug Administration (FDA) will hold the first round of summary hearings in August to finalize the certification and re-certification of disputed contraceptive products under their amended rules.

    FDA’s change in their screening process was made for the first time due to the Supreme Court (SC) decision on August 24, 2016 directing them to “formulate the rules of procedure in the screening, evaluation and approval of all contraceptive drugs and devices that will be used under Republic Act No. 10354 [Reproductive Health Law].”

    The amended rules of procedure will contain the minimum requirements needed for due process such as publication, intervention of interested parties, the standard laid down by the Constitution as to what constitutes allowable contraceptives, weighing of evidence and other requirements of the administrative due process.

    The high court, in a resolution on April 26, reiterated that the FDA should conduct a summary hearing and amend the Implementing Rules and Regulations of the RH Law to make it compliant with the court’s mandates.

    The FDA gave the assurance that they will “fast-track” the process to resolve the matter at the soonest possible time.

    “The latest statement of the SC is surprising. However, the FDA wishes to assure the public that it is closely following and faithfully complying with all the manifold and evolving directives issued by the SC,” FDA Director General Nela Puno said in a statement.

    President Rodrigo Duterte, in his second State of the Nation Address, urged the SC to lift the TRO on the RH Law.

    But Chief Justice Ma. Lourdes Sereno clarified that the tribunal did not issue a TRO against the RH Law. The TRO, she said, only covered the two specific contraceptives.

    “This pertains to two implants — Implanon and Impanon NXT. As clearly stated in the decision dated August 24, 2016 and again in [the]April 26, 2017 decision denying the motion for reconsideration, the TRO is limited to only those two implants,” Sereno said.

    The TRO was issued on June 17, 2015 in the case of Alliance for the Family Foundation Philippines, Inc. vs. former health secretary Janette Garin, et al.

    These implants are thin rods inserted under the skin which release hormones that could prevent pregnancy for up to three years.


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