The Public Should Know

Posted by on Dec 3, 2014 in Breaking News

AS DOH ACTING SECRETARY GARIN ASSURES THAT FDA CERTIFICATIONS WILL COME OUT FIRST WEEK OF DECEMBER, THE PUBLIC SHOULD KNOW………

The DOH budget of P1.025 billion for “family planning commodities” was approved upon the assurance given by DOH Acting Secretary Janette Garin to Senator Teofisto Guingona III, Chairman of the Senate Committee on Health, that the FDA certifications allowing the purchase by government and sale to the public of various contraceptive drugs and devices would come out the first week of December.

There are currently 50 pending applications for re-certification/reevaluation

of contraceptive drugs and devices filed by various pharmaceutical companies with the FDA. Alliance for the Family Foundation Philippines, Inc. (ALFI) filed Opposition (preliminary, then individual) to the said applications and to other 27 contraceptive drugs previously registered by the FDA. ALFI also sought the recall and withdrawal of the said drugs and devices from the market until a transparent, judicious and credible re-certification and re-evaluation process is conducted by the FDA. No public hearings have yet been set.

The Supreme Court in its Decision on the RH Law mandates the FDA to certify that all contraceptive drugs and devices that are made available to the public are Non-Abortifacient and Safe and Pose No Risks to the health of the Filipino public.

As defined under section 4(a) of the RH Law, an Abortifacient is any drug or device that either:

(a) Induces abortion; or

(b) Induces the destruction of a fetus inside the mother’s womb; or

(c) Induces the prevention of the fertilized ovum to reach and be implanted in the mother’s womb.

This definition of Abortifacient protects the fertilized ovum from fertilization until it reaches and implants in the uterus. Therefore, it behooves the FDA to observe and follow strictly, faithfully and conscientiously the SC Decision. The price for non-compliance is stiff and high—the LIFE and HEALTH OF THE FILIPINO PUBLIC—and the consequences thereof may be final, irretrievable and irreversible. And the Government and its responsible officials, employees and agents shall be put to task for the consequences.

The Supreme Court, recognizing the gravity of the consequences of distributing or making available to the public contraceptive drugs and devices, issued a WARNING, thus:

“A heavy responsibility and burden are assumed by the government in supplying contraceptive drugs and devices, for it may be held accountable for any injury, illness or loss of life resulting from or incidental to their use.”

In its Opposition, ALFI shows that, based on scientific and medical resources and materials:

1. Every single hormonal contraceptive, IUD and injectable, whether of a “combined estrogen-progesterone formulation” or of a “progestin-only formulation”, by its mechanism of action, causes changes in the uterine lining which make it harder for a fertilized egg to attach to the uterus, i.e., inhibit implantation. Such changes “induce the prevention of the fertilized ovum to reach and be implanted in the mother’s womb” which may then induce “abortion or the destruction of a fetus inside the mother’s womb,” as Abortifacient is precisely defined in the RH Law.

2. Every hormonal contraceptive, including IUD, injectable and implant (77 of them), previously registered by the FDA and is being sold in the Philippine market, invariably exhibits a mechanism of action that inhibits implantation of the fertilized ovum. There are also documented harmful effects on the health of women.

For the full text of the ALFI Opposition (preliminary and individual) and its attachments of supporting materials, including the Table of summary of relevant information on hormonal contraceptives, please click:

Preliminary Opposition

Preliminary Opposition

Volume 1

Volume 2

Individual Opposition

Individual Opposition

Attachments