E-Library - Information At Your Fingertips: Printer Friendly
18 of 48
http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027
[3] Id. at 402-403.
[4] Id. at 414-430.
[5] Section 7.04. FDA Certification of Family Planning Supplies.
The FDA must certify that a family planning drug or device is not an abortifacient in
dosages of its approved indication (for drugs) or intended use (for devices) prior to
its inclusion in the EDL. The FDA shall observe the following guidelines in the
determination of whether or not a drug or device is an abortifacient:
a) As defined in Section 3.01 (a) of these Rules, a drug or device is deemed to be an
abortifacient if it is proven to primarily induce abortion or the destruction of a fetus
inside the mother's womb or the prevention of the fertilized ovum to reach and be
implanted in the mother's womb;
b) The following mechanisms do not constitute abortion: the prevention of ovulation;
the direct action on sperm cells prior to fertilization; the thickening of cervical
mucus; and any mechanism acting exclusively prior to the fertilization of the egg by
the sperm;
c) In making its determination, the FDA shall use the best evidence available,
including but not limited to: metaanalyses, systematic reviews, national clinical
practice guidelines where available, and recommendations of international medical
organizations
d) In the presence of conflicting evidence, the more recent, better-designed, and
larger studies shall be preferred, and the conclusions found therein shall be used to
determine whether or not a drug or device is an abortifacient; and
e) Should the FDA require additional expertise in making its determination, an
independent evidence review group (ERG) composed of leading experts in the fields
of pharmacodynamics, medical research, evidence-based medicine, and other
relevant fields may be convened to review the available evidence. The FDA shall then
issue its certification based on the recommendations of the ERG.
[6] Rollo, pp. 414-416.
[7] Sec. 2. Duties and Functions of the Director-General x x x
b. Quasi-Judicial Powers, Duties and Functions:
xxx
[8] Otherwise known as the Food and Drug Administration Act of 2009.
4/21/2020, 9:19 AM