All 51 contraceptives under review by the Food and Drug Administration have been re-certified as non-abortifacient, effectively lifting the 29-month Temporary Restraining Order on the Reproductive Health law.
On November 10, the Food and Drug Administration (FDA) issued the Resolution 2017-302 which concluded that all 51 contraceptives are cleared as non-abortifacient, grounds used by pro-life groups who sought the TRO.
The resolution included clearing specific subjects of the Supreme Court TRO - Implanon and Implanon NXT. The order, issued in 2015, banned the procurement, sale and distribution of the contraceptive implants.
The FDA resolution read: "Per the FDA's Resolutions... with oppositions filed by Alliance for the Family Foundation, Philippines, Inc., the foregoing contraceptive products have been determined to be NON-ABORTIFACIENT."
At a press conference, FDA Director-General Nela Charade Puno said, "I am pleased to announce that we are done with the 51 resolutions containing - at length - a discussion of the evaluation process."
Each resolution contains a 7-page discussion of the individual review process, she said.
The announcement fulfilled one of the High Tribunal's directives in a resolution dated April 26, which directed the FDA to conduct "summary hearings" and amend the Implementing Rules and Regulations of the Responsible Parenthood and Reproductive Health Law or Republic Act 10345. Compliance of such directive will deem the TRO lifted.
With regard the other directive amending the IRR, this was already signed by erstwhile Secretary of Health Paulyn Ubial and the Drafting Committee of the RPRH law.
The full effectivity of the revised IRR took effect on November 13, and as with the FDA release of the resolution, the RH law can now be implemented.
The Department of Health welcomed the issuance and has already started distributing family planning commodities to the regional health offices.
At the same time, the Certificate of Product Registration (CPR) for the medicines will be available and the Health department can start procurement procedures, according to Health Undersecretary Gerardo Bayugo. Most of the contraceptive products will be expiring soon after being held from distribution for close to two years.
Dr Juan Antonio Perez, director of the Population Commission, earlier noted that the twin actions put in by the FDA and DOH meant the full implementation of the Reproductive Health law is back on track.
"The Commission on Population appreciates the diligence of the Food and Drug Administration in completing and approving the recertification of 51 contraceptives. This could not have come at a better time as depleted contraceptive supplies will not be augmented by over 200,000 implants," Director Perez said.
The DOH currently has no supply of progestin-only pills (POP), but their injectable contraceptive supplies are still good for six months.
The POPCOM chief said the department will prioritize the distribution of 261,000 implants - stored in its Manila-based warehouses - as their insertion time is set to expire by September 2018.
Once the implants are inserted, they will be effective for three years.
“The lifting of the TRO will allow DOH to start procuring commodities from its 2017 budget. All Filipinos working for women’s health should rejoice in this development,” Director Perez concluded. MIMS
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