Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

EIGHTEENTH CONGRESS
First Regular Session

House Bill No, 6903

Introduced by Representative Ron P. Salo

EXPLANATORY NOTE

Article XIII, Section 12 of the 1987 Constitution mandates that the “(t)he State
shall establish and maintain an effective food and drug regulatory system and
undertake appropriate health manpower development and research, responsive to the
country's health needs and problems.”

In view of the stated principle, the Food and Drug Administration (FDA) was
created by virtue of Republic Act No. 3720 as the agency to regulate, license, and
monitor the flow of food, drugs, cosmetics, medical devices, and household hazardous
waste in the Philippines. The agency's main goal is to ensure the health and safety of
food and drugs made available to the public, Its charter was later amended by Republic
Act No. 9711 in order to strengthen and rationalize its regulatory capacity.

Presently, the FDA is attached to the Department of Health (DOH) where
instances of potential conflicts of interest may occur. This set up weakens the
independence and autonomy of the FDA in the performance of its functions.

This bill seeks to make the FDA an independent and autonomous agency
attached to the Office of the President. This will enhance the agency's regulatory
capacity and enable it to operate independently with regard to its function to inspect
regulate, license, and monitor establishments and food, drugs, cosmetics, medical
devices, and household hazardous waste products in the country.

Hence, the immediate passage of this bill is earnestly sought.

RON P. SALO
KABAYAN Partylist

Page 1 of 16


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

EIGHTEENTH CONGRESS
First Regular Session

House Bill No, 6903

Introduced by Representative Ron P. Salo

AN ACT
MAKING THE FOOD AND DRUG ADMINISTRATION AN INDEPENDENT AND
AUTONOMOUS AGENCY, AMENDING REPUBLIC ACT NO. 3720, AS AMENDED
BY REPUBLIC ACT NO. 9711

Be it enacted by the Senate and the House of Representatives of the Philippines in
Congress assembled:

SECTION 1. independent and Autonomous Agency. — Section 4 of Republic
Act No. 3720, as amended by Republic Act No. 9711 shall now read as:

SEC. 4. To carry out the provisions of this Act, there is hereby
created an office to be called the Food and Drug Administration (FDA) [in
the—Depariment—of—Health_{DOH)}. THE FDA SHALL BE AN
INDEPENDENT AND AUTONOMOUS AGENCY ATTACHED TO THE
OFFICE OF THE PRESIDENT AND SHALL EXERCISE THE
FOLLOWING FUNCTIONS, POWERS, AND DUTIES: [Said

the following functions, powers-and-duties] 7
XXX

SEC. 2. Section 6 of Republic Act No. 3720, as amended by Section 7 of
Republic Act No. 9711, is hereby further amended to read as follows:

“(a) The FDA shall be headed by a Director-General, with the rank of
DEPARTMENT SECRETARY WHO SHALL BE
APPOINTED BY THE PRESIDENT SUBJECT TO CONFIRMATION BY
THE COMMISSION ON APPOINTMENTS AND who shall be tasked,
among others, to determine the needed personnel and to appoint
personnel, below the assistant [director] DIRECTOR-GENERAL level in
ination wis .| ACCORDANCE WITH CIVIL
SERVICE LAW, RULES AND REGULATIONS."

XXX

Page 2 of 16


"(h) Each center and field office shall be headed by a director who shall be
assisted by an assistant director. These directors shall be appointed by
the Seoretary-of Health DIRECTOR-GENERAL.

SEC. 3. Section 7 of Republic Act No. 3720, as amended by Section 8 of
Republic Act No. 9711, is hereby further amended to read as follows:

“Section 7. The FDA shall review its staffing pattern and position
titles. [subj

SEC. 4. Section 4. Section 11 of Republic Act No. 3720, as amended, is
hereby further amended to read as follows:

“Section. 11. The following acts and the causing thereof are hereby
prohibited:

XXX

(f) The using by any person to his own advantage, or revealing, other than
to the [Secretary] DIRECTOR-GENERAL or officers and employees of the
[Department] FDA or to the courts when relevant in any judicial proceeding
under this Act, any information concerning any method or process which
as a trade secret is entitled to protection.

XXX’

SEC. 5. Section 12 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 12. XXX

(b) No person shall be subject to the penalties of subsection (a) of this
section (1) for having sold, offered for sale or transferred any article and
delivered it, if such delivery was made in good faith, unless he refuses to.
furnish on request of the [Bureau] FDA or an officer or employee duly
designated by the [Secretary] DIRECTOR-GENERAL, the name and
address of the person from whom he purchased or received such article
and copies of all documents, if any there be, pertaining to the delivery of
the article to him; (2) for having violated Section 11(a) if he established a
guaranty or undertaking signed by, and containing the name and address
of, the person residing in the Philippines from whom he received in good
faith the article, or (3) for having violated Section eleven (a), where the
violation exists because the article is adulterated by reason of containing
a color other than the permissible one under regulations promulgated by
the [Secretary] DIRECTOR-GENERAL under this Act, if such person
establishes a guaranty or undertaking signed by, and containing the name
and address, of the manufacturer of the color, to the effect that such color
is permissible, under applicable regulations promulgated by the
[Secretary] DIRECTOR-GENERAL under this Act."

Page 3 of 16


SEC. 6. Section 13 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 13. Whenever in the judgment of the [Secretary]
DIRECTOR GENERAL such action will promote honesty and fair dealing
in the interest of consumers, he shall f
and Drug Administrator], promulgate regulations fixing and establishing for
any food, under its common or usual name so far as practicable, a
reasonable definition and standard of identity, a reasonable standard of
quality, and/or reasonable standards of fill of container: Provided, That no
definition and standard of identity and no standard of quality shall be
established for fresh or dried fruits, fresh or dried vegetables."

SEC. 7. Section 15 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 15. A food shall be deemed to be misbranded:
XXX

(e) If in package form unless it bears a label containing (1) the name and
place of business of the manufacturer, packer, distributor; and (2) an
accurate statement of the quantity of the contents in terms of weight,
measure, numerical count: Provided, That under clause (2) of this
paragraph reasonable variations shall be permitted, and exemptions as to
small packages shall be established, by regulations prescribed by the
[Secretary] DIRECTOR-GENERAL.

XK

(i) Ifitis not subject to the provisions of paragraph (g) of this section unless
its label bears (1) the common or usual name of the food, if there be any,
and (2) in case it is fabricated from two or more ingredients, the common
or usual name of each such ingredient; except that spices, flavorings, and
colorings, other than those sold as such, may be designated as spices,
flavorings and colorings without naming each: Provided, That to the extent
that compliance with the requirements of clause (2) of this paragraph is
impracticable or results in deception or unfair competition, exemptions
shall be established by regulations promulgated by the [Secretary]
DIRECTOR-GENERAL.

xxx"

SEC. 8. Section 16 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 16. (a) Whenever the [Secretary] DIRECTOR-GENERAL

finds after investigation that the sale or distribution in domestic commerce
of any class of food may be injurious to health, and that such injurious

Page 4 of 16


nature cannot be adequately determined after such articles have entered
domestic eon: he zal peu igate regulations [alse-in-accordance

oF] providing
for the lesuance, ta manufacturers, processors, or packers of auch ciase
of food in such locality, of permits to which shall be attached such
conditions governing the manufacture, processing, or packing of such
class of food, for such temporary period of time, as may be necessary to
protect the public health; and after the effective date of such regulations,
and during such temporary period, no person shall manufacture, sell or
offer for sale or transfer any such food manufactured, processed, or
packed by any such manufacturer, processor, or packer unless such
manufacturer, processor or packer holds a permit issued by the [Secretary]
DIRECTOR-GENERAL as provided by such regulations.

(b) The [Secretary] DIRECTOR-GENERAL is authorized to suspend
immediately upon notice any permit issued under FDA of this section if it
is found that any of the conditions of the permit have been violated.

(c) Any officer or employee duly designated by the [Secretary]
DIRECTOR-GENERAL shall have access to any factory or establishment,
the operator of which holds a permit from the [Secretary] DIRECTOR-
GENERAL, for the purpose of ascertaining whether or not the conditions
of the permit are being complied with, and denial of access for such
inspection shall be ground for suspension of the permit until such access
is freely given by the operator.”

SEC. 9. Section 17 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"Section 17. (a) Any poisonous or deleterious substance added to
any food, shall be deemed to be unsafe except when such substance is
required or cannot be avoided in its production or manufacture. In such
case the [Sesretary] DIRECTOR-GENERAL shall promulgate [upen

of the regulations limiting
the quantity therein to such extent as he finds necessary for the protection
of public health, and any quantity exceeding the limits so fixed shall also
be deemed to be unsafe. In determining the quantity of such added
substance to be tolerated in different articles of food the [Secretary]
DIRECTOR-GENERAL shall take into account the extent to which the use
of such article is required or cannot be avoided in the production or
manufacture of such article and the other ways in which the consumer may
be affected by the same or other poisonous or deleterious substances.

(b) The [Secretary] DIRECTOR-GENERAL shall [
promulgate regulations providing for
the listing of coal-tar colors which are harmless and suitable for use in

food."

Page 5 of 16


SEC. 10. Section 18 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“SEC. 18. A drug or device shall be deemed to be adulterated:
(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed
substance which may affect its safety, efficacy or good quality; or (2) if it
has been manufactured, prepared or held under unsanitary conditions
whereby it may have been contaminated with dirt or filth or whereby it may
have been rendered injurious to health; or (3) if it is a drug or device and
its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health;
or (4) if it is drug and it bears or contains, for purposes of coloring only,
any color other than a permissible one as determined by the [Secretary]
DIRECTOR-GENERAL, taking into consideration standards of safety,
efficacy or good quality.

(b) If it purports to be or is represented as a drug the name of which is
recognized in an official compendium, and its strength differs from, or its
safety, efficacy, quality or purity falls below the standards set forth in such
compendium, except that whenever tests or methods of assay as are
prescribed are, in the judgment of the [Secretary] DIRECTOR-GENERAL,
insufficient for the making of such determination the [Secretary]
DIRECTOR-GENERAL shall promulgate [

DIRECTOR-GENERAL] regulations prescribing appropriate tests or
methods of assay in accordance with which such determination as to
strength, safety, efficacy, quality, or purity shall be made. No drug defined
in an official compendium shall be deemed to be adulterated under this
paragraph because it differs from the standards of strength, safety,
efficacy, quality, or purity therefor set forth in such compendium, if its
difference in strength, safety, efficacy, quality or purity from such
standards is plainly stated in its label and approved for registration as
such.

XXX"

SEC. 11. Section 19 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 19. A drug or device shall be deemed to be misbranded: - (a)
If its labeling is false or misleading in any particular.

(b) If itis in package form unless it bears a label containing (1) the name
and place of business of the manufacturer, importer, packer, or distributor;
(2) an accurate statement of the quantity of the contents in terms of
weight. measure, or numerical count: Provided, That reasonable
variations shall be permitted and exemptions as to small packages shall
be established by regulations prescribed by the [Secretary] DIRECTOR-
GENERAL.

XXX

Page 6 of 16


(4) If it is for use by man and contains any quantity of the narcotic or
hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal,
cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana,
morphine, opium, paraldehyde, peyote, or sulfonmethane; or any chemical
derivative of such substance, which derivative has been recommended by
the [Secretary] DIRECTOR-GENERAL, after investigation, and by
regulations, designated as, habit forming; unless its label bears the name,
and quantity or proportion of such substance or derivative and in
juxtaposition therewith the statement’ "Warning - May be habit forming”

(e) If itis a drug and is not designated solely by a name recognized In an
official compendium unless its label bears (1) the common or usual name
of the drug, if such there be; and (2) in case it is fabricated from two or
more ingredients, the common or usual name of each active ingredient,
including the quantity, kind, and proportion of any alcohol, and also
including whether active or not, the name and quantity or proportion of any
bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine,
antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis
glycosides, mercury, ouabain, strophantin, strychnine, thyroid, or any
derivative or preparation of any such substances, contained therein:
Provided, That where compliance with this paragraph is impracticable,
exemptions shall f- i ]
be established by regulations promulgated by the [Seeretary] DIRECTOR-
GENERAL.

(f) Unless its labeling bears (1) adequate directions for use; and (2) such
adequate wamings against use in those pathological conditions or by
children where its use may be dangerous to health, or against unsafe
dosage or methods or duration of FDA or application, in such manner and
form, as are necessary for the protection of users: Provided, That where
any requirement of clause Cl) of this paragraph, as applied to any drug or
device, is not necessary for the protection of the public health, the
[Secretary] DIRECTOR-GENERAL shall {-

director-general] promulgate regulations exempting such drug or device
from such requirement.

(g) If it purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and labeled as prescribed therein:
Provided, that the method of packing may be modified with the consent of
the [Seoretary] DIRECTOR-GENERAL.

(h) If it has been found by the [Secretary] DIRECTOR-GENERAL to be a
drug liable to deterioration, unless it is packaged in such form and manner,
and its label bears a statement of such precautions, as the [Secretary]
DIRECTOR-GENERAL shall by regulations require as necessary for the
protection of the public health.

nox

Page 7 of 16


SEC. 12. Section 20 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“SEC. 20. (a) The [Secretary] DIRECTOR-GENERAL is hereby
directed to promulgate regulations exempting from any labeling or
packaging requirement of this Act drugs and devices which are, in
accordance with the practice of the trade, to be processed, labeled, or
tepacked in substantial quantities at establishments other than those
where originally processed or packed, on condition that such drugs and
devices are not adulterated or misbranded under the provisions of this Act
upon removal from such processing, labeling or repacking establishment.

(b) Xxx

(3) The [Secretary] DIRECTOR-GENERAL may by regulation remove
drugs subject to Section nineteen (d) and Sections twenty-one and twenty-
one-B from the requirements of subsection (b)(1) of this Section, when
such requirements are not necessary for the protection of the public health.

XXX.”

SEC. 13. Section 21 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 21. XXX

(b) Any person may file with the [Secretary] DIRECTOR-GENERAL f, thru

an application under oath with respect to any drug or device
subject to the provisions of subsection (a) hereof. Such persons shall
submit to the [Seeretary] DIRECTOR-GENERAL [thruthe- Bureau]: (1) full
reports of investigations which have been made to show whether or not
such drug or device is safe, efficacious and of good quality for use based
on clinical studies conducted in the Philippines; (2) a full list of the articles
used as components of such drug or device; (3) a full statement of the
composition of such drug or device; (4) a full description of the methods
used in and the facilities and controls used for the manufacture of such
drug or device; (5) such samples of such drug or device and of the articles
used as components thereof as the [Secretary] DIRECTOR-GENERAL
may require; (6) specimens of the labeling proposed to be used for such
drug or device; and (7) such other requirements as may be prescribed by
regulations to ensure the safety, efficacy and good quality of such drug or
device.

(c) Within one hundred and eighty days after the filing of an application
under this subsection, or such additional period as may be agreed upon
by the [Secretary] DIRECTOR-GENERAL and the applicant, the
[Secretary] DIRECTOR-GENERAL shall either -(1) approve the
application if he then finds that none of the grounds for denying approval
specified in subsection (d) applies, or (2) give the applicant notice of an
opportunity for a hearing before the [Secretary] DIRECTOR-GENERAL

Page 8 of 16


under subsection (d) on the question whether such application is
approvable.

(d) If the [Secretary] DIRECTOR-GENERAL finds, after due notice to the
applicant and giving him an opportunity for a hearing, that (1) the reports
of the investigations which are required to be submitted to the [Secretary]
DIRECTOR-GENERAL pursuant to subsection (b) hereof, do not include
adequate tests by all methods reasonably applicable to show whether or
not such drug or device is safe, efficacious and of good quality for use
under the conditions prescribed, recommended, or suggested in the
proposed labeling thereof; (2) the results of such test show that such drug
or device is unsafe, inefficacious or of doubtful therapeutic value for use
under such conditions or do not show that such drug or device is safe,
efficacious or of good quality for use under such conditions; (3) the
methods used in, and the facilities and controls used for the manufacture
of such drug or device are inadequate to preserve its identity, strength
quality and purity; or (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other information before
him with respect to such drug or device, he has insufficient information to
determine whether such drug or device is safe, efficacious or of good
quality- for use under such conditions; or (5) evaluated on the basis of the
information submitted to him as part of the application, and any other
information before him with respect to such drug or device, there is a lack
of substantial evidence that the drug or device will have the effect it
purports or is represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof, or (6) based
on a fair evaluation of all material facts, such labeling is false or misleading
in any particular; he shall issue an order disapproving the application.

(e) The effectiveness of an application with respect to any drug or device
shall, after due notice and opportunity for hearing to the applicant, by order
of the [Secretary] DIRECTOR-GENERAL be suspended if the [Secretary]
DIRECTOR-GENERAL finds (1) that clinical experience, tests by new
methods, or tests by methods not deemed reasonably applicable when
such application became effective show that such drug or device is unsafe
or ineffective for use under the conditions of use upon the basis of which
the application became effective, or (2) that the application contains any
untrue statement of a material fact. The order shall state the findings upon
which it is based.

(f) The [Secretary] DIRECTOR-GENERAL shall promulgate regulations
for exempting from the operation of this section drugs and devices
intended solely for investigational use by experts qualified by scientific
training and experience to investigate the safety and effectiveness of drugs
and devices. "(g) The procedure herein prescribed applies likewise to "new

veterinary drugs".

Page 9 of 16


SEC. 14. Section 21-A of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“SEC. 21-A. No person shall manufacture, sell, offer for sale,
import, export, distribute or transfer any drug or device without first
securing a license to operate from the [Bureau] FDA after due compliance
with technical requirements in accordance with the rules and regulations
promulgated by the [Secretary] DIRECTOR-GENERAL pursuant to this
Act.”

SEC. 15. Section 21-B of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 21-B. No drug or device shall be manufactured, sold, offered
for sale, imported, exported, distributed or transferred, unless registered
by the manufacturer, importer or distributor thereof in accordance with
rules and regulations promulgated by the [Secretary] DIRECTOR-
GENERAL pursuant to this Act. The provisions of Section 21(b), (d) and
(e), to the extent applicable, shall govern the registration of such drugs
and devices.”

SEC. 16. Section 21-C of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 21-C. The [Secretary] DIRECTOR-GENERAL shall
promulgate a schedule of fees for the issuance of the certificate of product
registration and the license to operate provided for under Sections 21, 21-
A, and 21-B."

SEC. 17. Section 22 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 22. (a) The [Secretary] DIRECTOR-GENERAL, pursuant to
regulations promulgated by him, shall provide for the certification of
batches of drugs composed wholly or partially of any kind of antibiotic. A
batch of such drug shall be certified if such drug has such characteristics
of identity, strength, quality and purity, as the [Secretary] DIRECTOR-
GENERAL prescribes in such regulations as necessary to insure
adequately safety and efficacy of use and good quality, but shall not
otherwise be certified Prior to the effective date of such regulations the
[Secretary] DIRECTOR-GENERAL, in lieu of certification, shall issue a
release for any batch which, in his judgment, may be released without risk
as to the safety and efficacy of its use. Such release shall prescribe the
date of its expiration and other conditions under which it shall cease to be
effective as to such batch and as to portions thereof. For purposes of this,
section and of Section nineteen (k), the term "antibiotic drug" means any
drug intended for use by man containing any quantity of any chemical
substance which is produced by a micro-organism and which has the
capacity to inhibit or destroy micro-organisms in dilute solution (including
the chemically synthesized equivalent of any such substance).

Page 10 of 16


(b) Whenever in the judgment of the [Secretary] DIRECTOR-GENERAL,
the requirements of this section and of Section nineteen (k) with respect
to any drug or class of drugs are not necessary to insure safety and
efficacy of use and good quality, the [Secretary] DIRECTOR-GENERAL
shall promulgate regulations exempting such drug or class of drugs from
such requirements.

(c) The [Secretary] DIRECTOR-GENERAL shall promulgate regulations
exempting from any requirement of this section and of Section nineteen
{k), (1) drugs which are to be stored, processed, labeled, or repacked at
establishments other than those where manufactured, on condition that
such drugs comply with all such requirements upon removal from such
establishments; (2) drugs which conform to applicable standards of
identity, strength, quality, and purity prescribed by these regulations and
are intended for use in manufacturing other drugs; and (3) drugs which are
intended for investigational use by experts qualified by scientific training
and experience to investigate the safety and efficacy of drugs.”

SEC. 18. Section 24 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 24. A cosmetic shall be deemed to be misbranded:

(b) If in package form unless it bears a label containing (1) the name and
place of business of the manufacturer, packer, or distributor; and (2) an
accurate statement of the quantity of the contents in terms of weight,
measure, of numerical count: Provided, That under reasonable variations
shall be permitted and exemptions as to small packages shall be
established by regulations prescribed by the [Secretary] DIRECTOR
GENERAL .

xxx"

SEC. 19. Section 25 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"Section 25. The [Secretary] DIRECTOR-GENERAL shall
promulgate regulations exempting from any labeling requirements of this
‘Act cosmetic which are, in accordance with the practice of the trade, to be
processed, labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on condition that
such cosmetics are not adulterated or misbranded under the provisions of
this Act upon removal from such processing, labeling, repacking
establishment.”

Page 11 of 16


SEC. 20. Section 26 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 26 (a) Except as otherwise provided in this section, the
|] “DIRECTOR-GENERAL shall [upon
it issue rules and regulations as

may be necessary to enforce effectively the provisions of this Act. The
rules and regulations shall provide for, among others, the banning,
recalling or withdrawing from the market drugs and devices which are not
registered, unsafe, inefficacious or of doubtful therapeutic value, the
adoption of an official National Drug Formulary, and the use of generic
names in the labeling of drugs.

(b) The Commissioner of Customs and the [Seeretaryef—Health]
DIRECTOR-GENERAL shall jointly prescribe regulations for the efficient
enforcement of the provisions of Section thirty, except as otherwise
provided therein. Such regulations shall [

i i] take effect at
such time, after due notice, as the [Secretary-of Health] DIRECTOR-
GENERAL shall determine.

XXX

(e) When any violation of any provisions of this Act comes to the
knowledge of the DIRECTOR-GENERAL of such character that a criminal
prosecution ought to be instituted against the offender, he shall certify the
facts to the Secretary of Justice [through-the Secretary of Health] together
with the laboratory report, the findings of the [Bureau] FDA, or other
documentary evidence on which the charge is based.

(f) The [Secretary] DIRECTOR-GENERAL is hereby authorized to call on
the assistance of any Department, Office or Agency for the effective
implementation of the provisions of this Act.

XXX"

SEC. 21. Section 27 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 27. (a) For purposes of enforcement of this Act, officers or
employees duly designated by the [Secretary] DIRECTOR-GENERAL,
upon presenting appropriate credentials to the owner, operator, or agent
in charge, are authorized (1) to enter, at reasonable hours, any factory,
warehouse, or establishment in which food, drugs, devices or cosmetics
are manufactured, processed, packed or held, for introduction into
domestic commerce or are held after such introduction, or to enter any
vehicle being used to transport or hold such food, drugs, devices, or
cosmetics, in domestic commerce; and (2) to inspect, in a reasonable
manner, such factory, warehouse, establishment, or vehicle and all

Page 12 of 16


pertinent equipment, finished and unfinished materials, containers, and
labeling therein.”

SEC. 22. Section 29 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 29. (a) The [Secretary] DIRECTOR-GENERAL may cause
to be disseminated information regarding foods, drugs, devices, or
cosmetics in situations involving, in the opinion of the [Secretary]
DIRECTOR-GENERAL, imminent danger to health, or gross deception to
the consumer. Nothing in this Section shall be construed to prohibit the
[Secretary] DIRECTOR-GENERAL from collecting, reporting, and
illustrating the results of the investigations of the [Department] FDA.

(b) The [Bureau] FDA shall publish a Drug Reference Manual and Drug
Bulletin to serve as reference by manufacturers, distributors, physicians,
consumers and such other groups as may be deemed necessary. The
[Bureau] FDA is hereby authorized to sell the Drug Reference Manual at
cost.”

SEC. 23. A new Section 30-A is hereby added to Republic Act No. 3720,
as amended, which shall read as follows:

“SEC. 30 (A). IN ANY ACTION TO ENFORCE THE PROVISIONS
OF THIS ACT RESPECTING A FOOD, DRUG, DEVICE, OR COSMETIC
REGULATION, FDA'S JURISDICTION SHALL BE PRESUMED TO.
EXIST."

SEC. 24, Section 32 of Republic Act No. 3720, as amended by Section 15
of Republic Act No. 9711, is hereby amended to read as follows:

"SEC. 32. The orders, rulings or decisions of the FDA shall be appealable
to the [Seeretary.of Health} OFFICE OF THE PRESIDENT. 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] OFFICE OF THE PRESIDENT is issued to stay
the execution thereof."

SEC. 25. Section 33 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 33. (a) The Commissioner of Customs shall cause to be
delivered to the [Bureau] FDA samples taken at random from every
incoming shipment of food, drugs, devices, and cosmetics which are being
imported or offered for import into the Philippines giving notice thereof to
the owner or consignee. The quantity of such samples shall be fixed by
regulation issued by the [Secretary] DIRECTOR-GENERAL. If it appears
from the examination of such samples or otherwise that (1) such article

Page 13 of 16


has been manufactured, under insanitary conditions, or (2) such article is
forbidden or restricted from sale in the country in which it was produced or
from which it was exported, or (3) such article is adulterated, misbranded,
or in violation of Sections twenty-one and twenty-one-B, then the [Director]
DIRECTOR-GENERAL shall so inform the Commissioner and such article
shall be refused admission, except as provided in subsection (b) of this
section. The Commissioner of Customs shall then cause the destruction
of any such article refused admission unless such article is exported, under
regulations prescribed by the Commissioner of Customs, within ninety
days of the date of notice of such refusal or within such additional time as
may be permitted pursuant to such regulations. If the foods, drugs,
devices, and cosmetics being imported or offered for import into the
Philippines arrives at a port of entry other than Manila, the collection of
such samples shall be the responsibility of the Regional Food and Drug
Supervisor having jurisdiction over the port of entry and such samples shall
be forwarded to the [Bureau] FDA.

(b) Pending decision as to the admission of an article being imported or
offered for import, the Commissioner of Customs may authorize delivery
of such article to the owner or consignee upon execution by him of a good
and sufficient bond providing for the payment of such liquidated damages
in the event of default as may be required pursuant to regulations of the
Commissioner of Customs. If it appears to the [Secretary] DIRECTOR-
GENERAL that an article included within the provisions of clause (3) of
subsection (a) of this section can, by relabeling or other action, be brought
into compliance with the Act or rendered other than a food, drug, device,
or cosmetic, final determination as to admission of such article may be
deferred, and upon filing of timely written application by the owner or
consignee, and the execution by him of a bond as provided in the
preceding provisions of this subsection, the [Secretary] DIRECTOR-
GENERAL may, in accordance with regulations, authorize the applicant to
perform such relabeling or other actions specified in such authorization
with regulations, including destruction or export of rejected articles or
portions thereof, as may be specified in the [Seeretarys] DIRECTOR-
GENERAL'S authorization. All such relabeling or other action pursuant to
such authorization shall be in accordance with regulations and be under
the supervision of an officer or employee of the Bureau of Customs
designated by the Commissioner of Customs and a duly authorized
representative of the [Bureau] FDA.

Xxx"

SEC. 26. Section 34 of Republic Act No. 3720, as amended by Section 17
of Republic Act No. 9711, is hereby further amended to read as follows:

“SEC. 34, Fees and Other Income. -

(a) [Upon-the-sole-approval of the Secretary] THE authorization and other
fees shall annually be determined and reviewed by the FDA and any

Page 14 of 16


proposed increase shall be published in two (2) leading newspapers of
general circulation.

XXX

(c) The Director-General of the FDA, [upon-approval-of-the-Secretary),
shall be authorized to promulgate rules and regulations governing the
collection of the ‘other related regulatory fees’. [

Secretary] THESE fees shall likewise be reviewed periodically and any
proposed increase shall be published in two (2) leading newspapers of
general circulation."

SEC. 27. Section 35 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

“Section 35. XXX

“The testing laboratories may be increased by the Director-General, [upon

|. Moreover, the director-general, [upon-approval
of the-Secretary] may call upon other government and private testing
laboratories to conduct testing, calibration, assay and examination of
samples of health products, Provided, that the private testing laboratories
are accredited by the Philippine Accreditation Office and the Department
of Trade and Industry and the [DOH] FDA.”

SEC. 28. Section 37 of Republic Act No. 3720, as amended, is hereby
further amended to read as follows:

"SEC. 37. The FDA [with-the approval ofthe Secratary,] shall create
organizational units which are necessary to address emerging concerns
and to be abreast to internationally acceptable standards. There shall be
created additional plantilla positions to augment the human resource and
complement of the FDA, subject to existing rules and regulations."

SEC. 29. Section 18 of Republic Act No. 9711 is hereby amended to read
as follows:

"SEC.18. XXX

The retention, use and application of this fund shall not be delayed,
amended, altered or modified, or affected in any way by an order or
directive from any executive office, but will be subject only to the general
accounting rules and guidelines by the Commission on Audit (COA). The
primary purpose of the fund as herein stated shall prevail over any other
purpose that may be pursued by the FDA on its own initiative or through
an order or directive by any higher office. The FDA shall submit to the
[Secretary—of-Health} PRESIDENT, the Secretary of Budget and
Management and the Congressional Oversight Committee, created under
Section 23 of this Act, a report on how the funds were utilized, including its
accomplishments.

Page 15 of 16


— All laws, decrees, executive orders or parts
thereof inconsistent with the provisions of this Act are hereby repealed, amended or
modified accordingly.

SEC. 31. Effectivity Clause. — This Act shall take effect fifteen (15) days after
its publication in the online version of the Official Gazette or in two (2) newspapers of
general circulation.

Approved.

Page 16 of 16