FDA asks for ‘sobriety’ on contraceptive review


The Food and Drug Administration (FDA) on Friday asked groups monitoring the re-evaluation and re-certification of contraceptives to “exercise sobriety” amid concerns raised over the transparency of the process.

FDA Director General Nela Charade Puno made the call in the wake of what the FDA said was “an escalating attack on the integrity of the agency and its processes” ahead of the conclusion of its review of several contraceptives products.

If the contraceptives, Implanon and Implanon NXT, will be certified as a non-abortifacient, the temporary restraining order (TRO) on the Reproductive Health Law would be effectively lifted.

The TRO was issued by the Supreme Court in the case of Alliance for the Family Foundation Philippines, Inc. vs former health secretary Janette Garin, et al.

Puno said the aspersions cast on the FDA and its processes “from various sides” was “unfair, not just to the agency but to the public it serves.”

She said the charges being aired by critics “are baseless and appear to merely aim at watering down the credibility of the decision the FDA may come up with at the end of the review process.”

The FDA is at the final stages of its evaluation and will soon announce its resolution on the contraceptive products.

It had also informed interested parties of the review process and had given them enough time to submit their evidence for or against the re-certification of the contraceptive products.

Puno said “hysterical remarks against the FDA and the review process” could derail the review process and cause further delay in the implementation of the Reproductive Health Law.

“The process is technical and scientific in nature and not a political one. As scientists, we work with empirical evidence and we make sure that our conclusions are based on facts and not on hysteria,” Puno said.

Earlier, Commission on Population (PopCom) executive director Juan Antonio Perez said the FDA would make an announcement this month pertaining to the results of the certification process of several contraceptives.

Perez said the FDA would release a resolution soon but there was no assurance that contraceptives up for certification or re-certification would be approved.

Puno, in a text message, said Health Secretary Francisco Duque 3rd and the FDA would issue the formal announcement next week.


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