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findings of the FDA simply because it will be weighing the scientific evidence
presented by both the FDA and its oppositors in determining whether the
contraceptive drug or device has complied with the requirements of the law.
Although the FDA is not strictly bound by the technical rules on evidence, as stated
in the Rules of Court, or it cannot be bound by the principle of stare decisis or res
judicata, it is not excused from complying with the requirements of due process. To
reiterate for emphasis, due process does not require that the FDA conduct trial-type
hearing to satisfy its requirements. All that the Constitution requires is that the FDA
afford the people their right to due process of law and decide on the applications
submitted by the MAHs after affording the oppositors, like the petitioners, a genuine
opportunity to present their sciencebased evidence.
The Appellate Procedure;
Appeal to the Office of the President
Incidentally, Section 32 of R.A. No. 3720 and Section 9 of Executive Order (E.O.) No.
247 provide that any decision by the FDA would then be appealable to the Secretary
of Health, whose decision, in turn, may be appealed to the Office of the President
(OP). Thus:
Sec. 32. The orders, rulings or decisions of the FDA shall be
appealable to the Secretary of Health. - An appeal shall be deemed
perfected upon filing of the notice of appeal and posting of the
corresponding appeal bond.
An appeal shall not stay the decision appealed from unless an order from
the Secretary of Health is issued to stay the execution thereof.
Sec. 9. Appeals. - Decisions of the Secretary (DENR, DA, DOH or
DOST) may be appealed to the Office of the President. Recourse to
the courts shall be allowed after exhaustion of all administrative
remedies.
In view thereof, the Court should modify that part of the Decision which allows direct
appeal of the FDA decision to the Court of Appeals. As stated in the said decision,
the FDA decision need not be appealed to the Secretary of Health because she
herself is a party herein. Considering that the Executive Secretary is not a party
herein, the appeal should be to the OP as provided in Section 9.
On the Prayer to Lift the TRO
The respondents lament that the assailed decision undermines the functions of the
FDA as the specialized agency tasked to determine whether a contraceptive drug or
device is safe, effective and non-abortifacient. They also claim that the assailed
decision requiring notice and hearing would unduly delay the issuance of CPR
thereby affecting public access to State-funded contraceptives. Finally, in a veritable
attempt to sow panic, the respondents claim that the TRO issued by the Court would
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