FDA to hear soon whether implants cause abortion
MANILA, Philippines (UPDATED) – Following the latest decision of the Supreme Court (SC) keeping the temporary restraining order in place, Health Secretary Paulyn Ubial said the Food and Drug Administration (FDA) will conduct public hearing and consultation on contraceptive implants "as soon as possible."
She echoed the SC's explanation that the TRO would be deemed lifted if the "questioned drugs and devices are found not abortifacient" by the FDA.
"After we've put in place the quasi-judicial function of FDA, we can actually start re-certification of the family planning commodities. And for the implant, it can be used again after public hearing and consultation," Ubial told reporters after a press conference on Tuesday, May 30.
In its recent decision, the SC blamed the DOH for the "supposed" delay in the distribution of contraceptive implants covered by a 2015 TRO.
The High Court noted that the FDA would have finished and resolved the opposition of the petitioners already by this time had it "immediately" conducted a summary hearing on the issue.
"We're having meetings right now to implement [the decision]," Ubial said on Tuesday. (READ: TRO on implants to stay, SC blames DOH for delay)
She added: "Basically, they did not lift the [temporary restraining order], but they provided guidance to the Department of Health on how to proceed to implement the decision of the Supreme Court."
The health secretry also pointed out the SC's clarification that "it's not a TRO on all contraceptives."
She noted, however, that some contraceptive products have already been withdrawn from the market, and these would have to be re-introduced, but the DOH is still studying how to go about it.
According to the Commission on Population (PopCom), only 23 contraceptives remain available for the public this year as a result of the TRO. It said 15 certificates of product registration expired in 2016, while 10 expired as of May 2017.
"By 2020, no contraceptives can be procured from the market," the PopCom said recently.
FDA to comply
In a statement on Tuesday, June 6, the FDA said it will comply with the SC's directive to promulgate rules of procedure in the screening, evaluation, and approval of all contraceptive drugs and devices, and to resolve the issue on whether the contraceptive implants covered by the TRO are abortifacient.
FDA Director General Nela Puno said they received a copy of the latest SC decision last June 1. Puno said they have "ample time to comply with the SC resolution" after they were given 60 days to decide on the case "from the date it will be deemed submitted for resolution."
She has already directed FDA's Center for Drug Regulation and Research, Center for Device Regulation Radiation & Research, and Legal Services Division to start with compliance.
"We assure the general public that FDA will comply based on scientific evidence and follow what is prescribed under the law with the public's health and safety being our paramount concern," Puno said. – Rappler.com
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