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Thus, comments and contributions at any stage of the process of certification made
by those concerned should not be simply received and filed. The Food and Drug
Administration should have gone beyond acknowledgment. It should have
summarized the issues and contentions in opposition and addressed them. No trial
type or even summary hearing is required. Rather than due process of law, this is
the essence of public participation enshrined in our Constitution.
ACCORDINGLY, the Food and Drug Administration should be ORDERED to consider
and respond to the oppositions filed regarding the re-certification of lmplanon and
lmplanon NXT based on the standards contained in the Reproductive Health Law and
the present revised standards contained in the present Implementing Rules and
Regulations within 60 days from receipt of this decision. Upon promulgation of the
resolution of the Food and Drug Administration, the Temporary Restraining Order
issued in this case is automatically lifted.
THEREAFTER, the Food and Drug Administration and the Department of Health
should amend its implementing rules in accordance with the decision and Imbong v.
Ochoa.[85]
[1] Food, Drug, and Cosmetic Act (1963).
[2] See Rep. Act No. 3720, chapt. III, sec. 4.
[3] See Exec. Order No. 851 (1982), sec. 4.
[4] See Rep. Act No. 9711, sec. 1.
[5] See Rep. Act No. 9711, sec. 5(m).
[6] See Implementing Rules and Regulations of Rep. Act No. 9711, Book II, art. I,
sec. 3(B).
[7] See Implementing Rules and Regulations of Rep. Act No. 9711, Book I, art. I,
sec. 5.
[8] See Rep. Act No. 3720, chapt. II, sec. 2.
[9] See Implementing Rules and Regulations of Rep. Act No. 9711, Book I, art. VII,
sec. 1 (a) to (d).
[10] Defined in Adm. Order No. 67 (1989), sec. 3, 3.2.4 as "a drug the safety and
efficacy of which has been demonstrated through long years of general use and can
be found in current official USP-NF, and other internationally-recognized
pharmacopoeia."
4/21/2020, 9:19 AM
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