Advisories

AIDE MEMOIRE SC TOR on Contraceptives

AIDE MEMOIRE
SC TOR on Contraceptives

 

I. Background

On 17 June 2015, the Supreme Court issued a temporary restraining order (TRO) in the case of Alliance for the Family Foundation Philippines, Inc. (ALFI), et al. vs. Dr. Janette L. Garin, et al. (G.R. No. 217872), clearly “enjoining the respondents (including the FDA), their representatives, agents or other persons acting on their behalf from: (1) granting any and all pending applications for registration and/or recertification for reproductive products and supplies including contraceptive drugs and devices; and (2) procuring, selling, distributing, dispensing or administering, advertising and promoting the hormonal contraceptive ‘Implanon’ and ‘Implanon NXT’.”

II. Immediate effect: FDA suspends its certification/re-certification process

In compliance  to the clear language of the TRO, the FDA duly suspended its existing certification and re-certification systems and all pending applications for certificate of product registration involving all contraceptive drugs and devices.

III. Motions to lift TRO denied by SC

On 24 August 2016, the Supreme Court denied the Government’s motion to lift the TRO. 

IV. SC directs FDA to formulate rules and afford due process

The 24 August 2016 Decision DIRECTED the FDA to be more circumspect in its regulatory actions, especially considering that the Supreme Court had declared therein that the FDA’s actions were subject to judicial review and that it could be held guilty of contempt for violation of the TRO by continuing with the processing and granting of applications involving contraceptive drugs and devices.

The said Decision also directed the FDA for the first time to “formulate the rules of procedure in the screening, evaluation and approval of all contraceptive drugs and devices," strictly observing due process. It was clear from the directive of the SC that the conduct of the proceedings by the FDA should be adversarial in nature.

V. SC Resolution dated 26 April 2017,

The SC again would reject the prayer to lift the TRO in its 26 April 2017 Resolution.

 

This again directed FDA  to conduct "summary hearing" and amend IRR of RH Lawand  reiterated that the TRO still subsists and could not be lifted until “after compliance with due process and upon promulgation of the decision of the Food and Drug Administration”. 

In the same Resolution, the SC also directed the FDA for the first time to conduct summary hearings, and to amend the implementing rules and regulations of the Reproductive Health Law (R.A. No. 10354) in strict compliance with the mandates of the Court.

VI. FDA actions

  1. In compliance with these SC directives, the FDA proceeded to modify and revise its usual certification and re-certification processes to make it strictly compliant with the High Court’s Decision.
  2. The FDA has already finalized the amended Rules of Procedure/Guidelines for the certification and re-certification of ALL contraceptive products.
  3. FDA is  set to hold the first round of summary hearings under the amended procedure this August 21, 2017.

VII. Net effect on RH Law implementation

Considering all the circumstances and incidents in the pending case, the FDA is surprised by the latest SC statement  to the effect that “what has been issued was a TRO against two specific contraceptives” only, referring to Implanon and Implanon NXT.

The language of the 2015 TRO is CLEAR: 

  1. The TRO  required the FDA to suspend its certification/re-certification of all contraceptives.
  2. The FDA was tasked to revise all the relevant procedure and IRR, 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. 

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.

Nevertheless, the FDA is doing its best to closely keep up and faithfully comply with all the manifold and evolving directives issued by the Supreme Court in the pending case. FDA will fast track the hearings and decide applications involving contraceptive products, so this case can be resolved soonest.

 

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