Supreme Court asks for proof of contraceptive safety; FDA to comply

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  • SC: TRO will be lifted if FDA presents proof contraceptives are non-abortifacient
  • SC said it would be "premature" and "presumptuous" to make a decision without submitted proof from FDA
  • FDA announced it would comply with SC
  • SC tells FDA to submit its old documents used in certifying the drugs
  • Only petitioners, not pharmaceutical companies, have to submit proof of safety

Metro Manila (CNN Philippines, May 26) ­— The Supreme Court (SC) is not lifting its temporary restraining order on contraceptives — at least until the Food and Drug Administration (FDA) presents proof the contraceptives are safe.

In excerpts of a decision released on May 26, the court unanimously denied the omnibus motion for reconsideration on its August 24, 2016 decision not to lift the TRO.

However, the court modified its 2016 decision and ordered the FDA "to consider the oppositions filed by the petitioners with respect to the listed drugs... and to decide the case within sixty (60) days from the date it will be deemed submitted for resolution."

"After compliance with due process and upon promulgation of the decision of the Food and Drug Administration, the [TRO] would be deemed lifted if the questioned drugs and devices are found not abortifacient," the decision read.

Any appeal after the FDA's final decision, the Supreme Court said, should be sent to the Office of the President.

The Supreme Court order, issued in 2015, prevents the FDA from granting and renewing certifications for contraceptives for women. It also prevents the DOH from distributing implants, a common method supported by government after the legislation of the Reproductive Health Law.

Related: This might be your last year to access birth control

The TRO was released after pro-life group Alliance for the Family and Foundation (ALFI) argued in court that the contraceptives had abortifacient qualities.

The recent resolution was reached by the Supreme Court Special Second Division during the Summer Session in Baguio City and was dated on April 26.

FDA to comply

The FDA has since announced that it would "comply with the directive of the Supreme Court," it said in a statement dated June 6.

The agency added it would "[promulgate] its rules of procedure in the screening, evaluation and approval of all contraceptive drugs and devices, and [resolve] the issue on whether or not the subject contraceptive drugs and devices are abortifacient."

"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," FDA Director General Nela Charade Puno was quoted as saying.

She added they had "ample time" to comply with the resolution.

According to the release, Puno directed the FDA's Center for Drug Regulation and Research, the Center for Device Regulation Radiation and Research, and the Legal Services Division, to start working on the compliance.

The FDA said they received a copy of the resolution on June 1.

Clarifications from SC

The Supreme Court also noted that its 2016 decision only covered two contraceptives, Implanon and Implanon NXT.

"It never meant to enjoin the processing of the entire gamut of family planning supplies that have been declared as unquestionably non-abortifacient," the decision read. "Moreover, the injunction issued by the Court was only subject to the condition that the respondents afford the petitioners a genuine opportunity to their right to due process."

Certificates for contraceptives have been expiring since 2015, with the last expected to expire in 2020. According to a list by the Commission on Population (POPCOM), 14 contraceptives are expiring by the end of 2017, and another 14 by next year.

Related: POPCOM lists 23 contraceptives left on the market, most expiring in 2018

The 2016 decision also asked the FDA to conduct a hearing to allow oppositors to the contraceptives to air their grievances. The Department of Health and reproductive health advocates argue that a public hearing would add unnecessary bureaucracy to the process.

However, the Supreme Court statement says that it is actually the shortest way around the issue.

"Had the FDA immediately conducted a summary hearing, by this time it would have finished it and resolved the opposition of the petitioners," the decision read.

It also noted that "there was already a finding by the FDA, which was the basis in registering, certifying and recertifying the questioned drugs and devices."

The Supreme Court also clarified that the procedure "does not require a trial-type hearing but may consider the opposition of the petitioners as well as the best scientific evidence available which it may obtain on its own."

It added that it was only the petitioners who had to present the proof, not the pharmaceutical companies.

"The only entities that would present evidence would be the petitioners to make their point by proving with relevant scientific evidence that the contraceptives have abortifacient effects," the release read. "Thereafter, the FDA can resolve the controversy."

POPCOM has also repeatedly called on the Supreme Court to lift the order, with its most recent statement also released on Friday.

"The TRO should be lifted now if we have to avert an impending national health crisis," POPCOM Executive Director Dr. Juan Antonio Perez III said in a press release.  "Unsafe induced abortions may also rise without a [family planning] program in place."