General & Misc

CA junks Plea vs FDA Certification of 51 Contraceptives

Date: 12 June 2018; Type: Legal News; Source: Philippine News Agency

MANILA, June 12 (PNA) - The Court of Appeals (CA) junked the motion for reconsideration filed by pro-life group Alliance For the Family Foundation Philippines, Inc. (ALFI) seeking to stop the Food and Drug Administration (FDA) from certifying 51 contraceptives as safe and non-abortifacient.

“We deny the petitioner’s motion for reconsideration for failure to exhaust administrative remedies. The petitioner should have filed the appeal with the Office of the President to assail the 51 resolutions of the FDA,” read the five-page resolution penned by Associate Justice Nina Antonio Valenzuela, the CA’s Former Special Seventeenth Division.

The CA did not give credence to the claim of ALFI that the doctrine of exhaustion of administrative remedies is not applicable considering that an appeal with the Office of the President would be futile considering the pronouncements of President Rodrigo Duterte to fully implement the Reproductive Health Law by distribution of modern contraception, including contraceptive drugs and devices.

The appellate court explained that according to Section 32 of Republic Act 9711 (Food and Drug Administration Act of 2009) and Section 9 of Executive Order No. 247 (Prescribing Guidelines and Establishing A Regulatory Framework for the Prospecting Biological and Genetic Resources, their By-Products and Derivatives, for Scientific and Commercial Purposes, and For Other Purposes), the orders, rulings and decisions of FDA are appealable to the Secretary of Health and the latter’s decisions may be appealed to the Office of the President.

Likewise, the CA noted the Supreme Court (SC) resolution dated on April 26, 2017 in the case of ALFI, et al, v. Garin, has ruled that FDA decisions need both be appealed to the Secretary of Health when the latter is a party to the case.

Instead, the SC held that the proper recourse is appeal to be filed with the Office of the President.

“Applying the Supreme Court pronouncement in the Garin case to this case, since the Executive Secretary is not a party in this case, the remedy to question the 51 FDA resolutions is to file the appeal with the Office of the President, and not via petition for review with this Court,” the CA pointed out.

It can be recalled that the FDA issued resolutions in December last year re-certifying as safe and non-abortifacient a list of 51 contraceptives, paving the way for the implementation of one of the key measures of the Reproductive Health Law.

Included in the list are implants like Implanon and Implanon NXT; injectables like Protec, intrauterine devices Mirena and Securit-T; and pills or oral contraceptives like Estrelle, Daphne, Yasmin, and Nordette, among others.

The move effectively lifted the Temporary Restraining Order (TRO) issued by the Supreme Court in 2015 which nullified the certification and re-certification earlier issued by the agency FDA covering contraceptive drugs and implants due to the failure of the DOH to observe and comply with the basic requirements of due process.

The Court held that the FDA certified, procured and administered contraceptive drugs and devices, without the observance of the basic tenets of due process, without notice and without public hearing, despite the constant opposition from ALFI.

The SC directed the FDA to formulate rules of procedure in the screening, evaluation, and approval of all contraceptive drugs and devices that will be used under Republic Act No.10354, otherwise known as the Responsible Parenthood and Reproductive Health Act of 2012.

It should contain, according to the Court, the minimum requirements of due process such as publication, notice and hearing; allowing interested parties to intervene; strictly following the standard laid down in the Constitution and RA 10354 as to what constitute allowable contraceptives should be followed, that is, those which do not harm or destroy life of the unborn from conception/fertilization; and in weighing evidence, all reasonable doubts should be resolved in favor of the protection and preservation of the right to life of the unborn from conception/fertilization.

The Court also tasked the DOH in coordination with other concerned agencies to formulate the rules and regulations which will govern the purchase and distribution of contraceptives covered by the certification from the FDA that said product and supply will not be used as an abortifacient.

The health department was also directed to come up with the complete and correct list of government reproductive health programs and services under RA 10354 which will serve as the template for the complete and correct information standard and to distribute the same to all health care service providers covered by the said law.

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