FDA assures transparency in contraceptives review

The Food and Drug Administration (FDA) on Monday reassured the public that the conduct of evaluation and reevaluation of contraceptives, including those covered by a Supreme Court (SC) order, “is aboveboard and transparent.” (Photo: Food and Drug Administration Philippines/ Facebook)

MANILA — The Food and Drug Administration (FDA) on Monday reassured the public that the conduct of evaluation and reevaluation of contraceptives, including those covered by a Supreme Court (SC) order, “is aboveboard and transparent.”

Results of the process “will be fully compliant with the standards set by the High Court,” said FDA Director-General Nela Charade Puno in a statement.

Puno said the agency is nearing completion of the review in line with the certification and recertification of some 50 contraceptives.

The move comes after the SC specifically ordered the FDA “to observe the basic requirements of due process by conducting a hearing, and allowing the petitioners to be heard, on the re-certified, procured, and administered contraceptive drugs and devices, including Implanon and Implanon NXT; and to determine whether they are abortifacients or non-abortifacients.”

In the same ruling, the high court also directed the FDA to formulate rules for screening, evaluation and approval of all contraceptive drugs and devices to be used under the Reproductive Health Law.

The contraceptives are covered by an SC order for recertification following a petition by civic group Alliance for the Family Foundation Philippines Inc.

According to Puno, the pieces of evidence submitted by various groups either to support or oppose the approval of the contraceptives “have been strongly considered and evaluated in this process.”

“We are grateful for the interest and the productive participation of these civic groups in the process,” Puno said. She added that the input given by these groups “have ensured that the results of the certification and recertification processes will have solid technical and scientific bases.”

Prior to this, the FDA urged interested groups to submit inputs for the certification and recertification process to provide the agency with evidence last August 21.

Interested parties were given 10 days to submit their inputs and were informed of the process that the FDA will follow in the evaluation and review of the contraceptives concerned.

Puno clarified the FDA is strictly following the standards set by the High Court as contained in its decision in a related court case.

“We will make sure that the results of the technical and scientific processes to evaluate and reevaluate these contraceptives will be made accessible to the public,” she said.

She further assured that “scientists who comprise the technical evaluation team of the FDA adhere to the highest professional standards and are committed to a transparent evaluation process.”

“These standards of excellence and transparency ensure that the interest of the public is protected,” Puno said.