FDA refutes Sereno’s remark on contraceptive implants

MANILA, Philippines - After the Commission on Population, the Food and Drug Administration (FDA) has also rebutted the pronouncement of Chief Justice Maria Lourdes Sereno that the temporary restraining order (TRO) issued by the Supreme Court only covered specific contraceptive drugs and devices.

In its aide-mémoire on the Court’s TRO on contraceptives, the FDA said Sereno’s recent statement implied “that ‘what has been issued was a TRO against two specific contraceptives’ only, referring to Implanon and Implanon NXT.”

The FDA, however, noted the “language of the 2015 TRO is clear: the TRO required the FDA to suspend its certification/re-certification of all contraceptives.”

“The FDA was tasked to revise all the relevant procedure and implementing rules and regulations, conduct hearings and decide on all applications under the revised procedure – the very conditions on which the lifting of the TRO has been made to depend,” it added.

The agency said the “overall circumstances of the case have had the net effect of burdening and restraining the FDA from performing its mandate and regulatory functions in a timely and efficient manner.”

“The result was that the speedy and effective implementation of the Reproductive Health Law has been stalled in the meantime,” the FDA added.

In his second State of the Nation Address on July 24, President Duterte had branded the TRO as a “bane of government (projects)” as it impedes the full implementation of the Responsible Parenthood and Reproductive Health law.

In response to this, Sereno claimed that the TRO does not cover all contraceptives but merely the implants and that the TRO could not be lifted, as FDA has not issued a certification that the contraceptives are not abortifacient.