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FDA to conduct hearings on contraceptive implants

Health Secretary Paulyn Jean Rosell-Ubial said on Friday that the Food and Drug Administration will conduct public hearing and consultation on contraceptive implants “as soon as possible.”

The public hearing will be conducted after the Supreme Court failed to lift the temporary restraining order on contraceptives.

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Ubial said 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 recertification of the family planning commodities. And for the implant, it can be used again after public hearing and consultation,” said Ubial.

“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,” she added.

In its recent decision, the SC blamed the DoH for the “supposed” delay in the distribution of contraceptive implnts covered by a 2015 TRO.

She noted the SC’s clarification that “it’s not a TRO on all contraceptives.” However, she said some contraceptive products have already been withdrawn from the market, and these would have to be re-introduced, but the DoH is still studying how to go about it.

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.

The Commission on Population said that 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.

Commission on Population Executive Director Dr. Juan Antonio Perez III has earlier warned that unsafe induced abortions may also rise without a family planning program, as more than 300,000 women signed a petition urging the Supreme Court to lift the existing TRO  on contraceptives.

With the TRO in place, Perez said unintended pregnancies may rise which may result to induced abortion and maternal deaths.

He said this may also result to increase in population which has been expressed by Filipinos as a major national concern through the Pulse Asia Research’s Ulat ng Bayan in March 2017.

He said the TRO on the distribution, dispensing, and promotion of subdermal implants and on certification and recertification of family planning commodities should be lifted now if the country has  to avert an impending national health crisis.

The lifting of the TRO, he said, will also pave the way for the full implementation of the 2012 Responsible Parenthood and Reproductive Health Act that has been deemed by CSOs and the population and development sector as dysfunctional for five years.

The RPRH Law guarantees universal access to all methods of modern contraception, comprehensive sexuality education, and maternal and child care.

Over a hundred of women and men mostly coming from urban poor communities went to the Supreme Court to submit the signed petition.

In June 2015, the SC issued a TRO to DoH and its agents to “temporarily” stop “procuring, selling, distributing, dispensing or administering, advertising and promoting the hormonal contraceptive Implanon and Implanon NXT.”

The TRO also prohibited the DoH and the Food and Drug Administration from registering and recertifying contraceptives in the subsequent SC decision in August 2015.

As a result, 15 certificates of product registration expired last 2016 while 10 expired as of May this year, leaving only 23 contraceptives available for the public.

By 2020, no contraceptives can be procured from the market. As such, CPR expirations will effectively lead to a total phaseout of FP commodities in the market before 2020. Without FP commodities, the Philippines’ national Family Planning program will effectively be put to a halt.

As part of a signature campaign led by the civil society organizations, over 300,000 individual Filipino women, couples and their families and friends from across the regions of the country had signed a multisectoral petition to urge the High Court to lift the TRO that has been in effect for the past two years.

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