FDA to certify implants as not inducing abortion – PopCom
MANILA, Philippines (2nd UPDATE) – The Food and Drug Administration (FDA) is set to issue a resolution certifying contraceptive implant brands Implanon and Implanon NXT as "non-abortifacients" or not inducing abortion, according to the Commission on Population (PopCom).
PopCom executive director Juan Antonio Perez, who said he was given permission by the FDA to make the announcement, said this pending resolution would effectively lift the Supreme Court's (SC) two-year-old temporary restraining order (TRO) on contraceptives.
Both PopCom and FDA are agencies under the Department of Health (DOH).
"FDA will declare contraceptives as non-abortifacients, lifting the TRO. Full implementation of the RH Law is now on track," Perez said in a press conference on Thursday, November 2.
"The FDA is still not able to announce the full list, although I have been assured that whatever decision they make, the resolution will lift the TRO. So Implanon would have to be cleared because that is part of the SC decision," he added.
Perez said a total of 51 contraceptive products are up for recertification by the FDA, which includes Implanon and Implanon NXT.
He added that the DOH expects the FDA to release its resolution "soon", though he cannot assure the public that all 51 contraceptives will be cleared by the regulatory agency.
LOOK: The 51 contraceptive products up for recertification by the FDA pic.twitter.com/QRP1qi5p1I— Mara Cepeda (@maracepeda) November 2, 2017
FDA director-general Nel Charade Puno, however, said PopCom's announcement is still "unofficial."
"Secretary [Francisco] Duque III and FDA will issue its formal announcement next week," she said in a text message.
In 2015, the High Court issued a TRO prohibiting the DOH from "procuring, selling, distributing, dispensing or administering, advertising and promoting the hormonal contraceptive 'Implanon' and 'Implanon NXT,” which can prevent pregnancies up to 3 years.
The SC said it would only lift the TRO once the FDA certifies the two brands as non-abortifacients.
The same TRO had also prohibited the FDA from “granting any and all pending application for reproductive products and supplies, including contraceptive drugs and devices.”
This clause in the SC ruling stopped pharmaceutical companies from issuing product registrations for existing contraceptive brands. New brands of contraceptives could not be registered as well. (READ: [Dash of SAS] Harmful side effects of SC TRO on contraceptives)
The latest issuance of the FDA is therefore a welcome development for advocates of the full implementation of the Reproductive Heath (RH) Law.
No less than President Rodrigo Duterte himself had appealed to the SC to lift its two-year-old TRO on contraceptive implants.
In January of this year, Duterte signed an executive order ensuring zero unmet needs for family planning in the country.
Socioeconomic Planning Secretary Ernesto Pernia said the EO is "expected" to put pressure on the SC to finally rule on the petition against contraceptive implants. – Rappler.com
In these changing times, courage and clarity become even more important.
Take discussions to the next level with Rappler PLUS — your platform for deeper insights, closer collaboration, and meaningful action.
Sign up today and access exclusive content, events, and workshops curated especially for those who crave clarity and collaboration in an intelligent, action-oriented community.
As an added bonus, we’re also giving a free 1-year Booky Prime membership for the next 200 subscribers.
You can also support Rappler without a PLUS membership. Help us stay free and independent by making a donation: https://www.rappler.com/crowdfunding. Every contribution counts.