FDA certification needed for distribution of contraceptives under TRO — Popcom

DAVAO CITY (MindaNews/21 July) – The Food and Drug Administration needs to come out with a review on Implanon, a type of sub-dermal implant contraceptive, within the next two to three months that will certify it as not abortifacient, an official of the Commission on Population (Popcom) said Thursday.

The certification will allow the government to distribute about 300,000 Implanon expiring next year, Popcom executive director Dr. Juan Antonio A. Perez III, told reporters during the 2017 Regional Population Congress at the Pinnacle Hotel in Davao City.

He said the distribution of Implanon worth P250 million was halted after the Supreme Court issued a temporary restraining order on it on June 17, 2015.

He said the SC required the FDA to do a review on Implanon to ensure its safety. Once it gets FDA approval, he said, the two-year old TRO will be automatically lifted.

He said the FDA is coming up with guidelines in conducting a review and recertification of Implanon and 49 other contraceptives in the country.

“We are just waiting for them to issue it. Once they issue the guidelines, there will be a notice for a hearing with all the oppositions. They will make a public announcement, write those who are against it,” he said.

Perez said the FDA will study the outcome of the hearing for 30 days and get experts to review the complaints against the use of Implanon.

He added the agency will then have another 60 days to decide on whether the use of this contraceptive is safe for women.

“FDA will make an independent consideration and they will give their decision in a manner that will make all parties understand,” he said.

But the official said the FDA decision may still be questioned before the Office of the President.

“The argument posed by FDA is that in issuing Certificate of Product Registration, they are exercising merely regulatory powers and not quasi-judicial powers, as such, administrative due process should not apply.

“Ruling on the said issue, the court finds that ‘regulatory powers’ is covered by the ‘enabling powers’ while the latter is a subcategory of quasi-judicial power, and as such, in issuing CPRs the FDA is exercising quasi-judicial powers,” he explained. (Antonio L. Colina IV/MindaNews)