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DOH, FDA urged to review contraceptives procured sans public hearing

/ 08:15 PM September 15, 2016

The government’s reproductive health program is practically back to square one after the Supreme Court ordered the Department of Health (DOH) and the Food and Drug Administration (FDA) to conduct a fresh round of certification process on the government’s stockpile of contraceptives they have previously endorsed without public hearings.

The SC ruling reached on Aug. 24 meant that the 400,000 subnormal birth control implants, including Implanon and Implanon NXT, that then Health Secretary Janet Garin procured at P500 or 10 percent of the P5,000 market price through the help of the Bill & Melinda Gates Foundation, would remain in government warehouses unless the FDA and DOH convince anti-abortion groups that these were not abortifacients.

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SC spokesperson Theodore Te announced that the SC second division led by Associate Justice Antonio Carpio upheld the separate petitions of the Alliance for the Family Foundation and its president Maria Concepcion Noche requiring the FDA to hear their side on the abortive effects of the birth control implants before their procurement and distribution as stated in the guidelines set by the high court in the implementation of the Responsible Parenthood and Reproductive Health Act of 2012 (Republic Act 10354).

Te said the court also shot down a petition to lift the temporary restraining order issued on June 17, 2015, by the Office of the Solicitor General which warned about the wastage of government resources, with the expiry of thousands of Implanon and Implanon NXT in warehouses, and the possibility of an acute shortage of contraceptives in the market.

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Te said that the FDA certified, procured, and administered 77 drugs that the petitioners claimed were abortifacients without public hearings in violation of the constitutional right to due process of the petitions.

The court ordered the DOH and FDA to tweak its implementing rules and regulations in the purchase of birth control drugs to conform with guidelines laid down by the court which required mandatory public hearings and allowing petitioners to intervene in the process of accreditation and procurement.

It also ordered the FDA to start the public hearings within 30 days after receipt of the ruling.

In its ruling, the FDA was ordered to be biased in favor of protecting the fetus. “In weighing the evidence, all reasonable doubts shall be resolved in favor of the protection and preservation of the right to life of the unborn from conception and fertilization,” said the court.

The court ordered the DOH to make sure that it would provide “sufficient details” on the regulation of the contraceptives “in order that they will not be used as an abortifacient and to sufficiently safeguard the right to life of the unborn.”

Te said the court also didn’t see any need for the lifting of the TRO on the distribution and sale of contraceptives.

The court said it was not stopping the FDA from its role as the primary arbiter of determining whether a contraceptive has abortifacient effects; it was just stopping the FDA from certifying or recertifying contraceptives without a public hearing to determine their effects on the fetus.

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TAGS: Birth Control, contraceptives, Department of Health, Food and Drug Administration, Implanon, Implanon NXT, reproductive health, Supreme Court
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