Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH (17") CONGRESS
Second Regular Session

House Bill No. 7143

Introduced by: Representative Jose L. Atienza, Jr.

EXPLANATORY NOTE

Since its establishment under Republic Act (R.A.) 3720 in 1963, the Food and Drug
Administration (FDA) has always been under the Department of Health (DOH).

This bill seeks to amend R.A. 3720, as amended by R.A. 9711, by creating an FDA that
shall be separate and independent from the DOH. For too long, the FDA has been carrying out its
mandate, but always under the supervision of the DOH. As such, not only has it taken them far too
Tong to act on issues concerning the safety and efficacy of various food, drugs, devices, vaccines
and other materials.

With this bill, the new FDA shall be empowered not only to issue cease and desist orders
(CDOs), but to order the ban, recall, and/or withdrawal of any health product found to have caused
the death, serious illness or serious injury to a consumer or patient, or is found to be imminently
injurious, unsafe, dangerous, or grossly deceptive

Incidents such as that of the Dengvaxia vaccine being found to be unsafe for the more than
700,000 children who had been inoculated, is a very valid case for an independent and)stronger
FDA that can immediately act on such cases of national import. :



Republic of the Philippines
Congress of the Philippines
Metro Manila

HOUSE OF REPRESENTATIVES

Seventeenth Congress
Second Regular Session

7143

House Bill No.

Introduced by Rep. Jose L. Atienza, Jr.

AN ACT CREATING A SEPARATE AND INDEPENDENT
FOOD AND DRUG ADMINISTRATION, AMENDING FOR SUCH
PURPOSE REPUBLIC ACT 3720, AS AMENDED BY
REPUBLIC ACT 9711

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

Section 1. Section 4 of Republic Act No. 3720, as amended by Republic
Act 9711, is hereby further amended to read as follows:

"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), whieh shall be
separate and independent from the Department of Health (DOH). The
FDA shall have the following functions, powers and duties:

"(a) To administer the effective implementation of this Act and of the rules
and regulations issued pursuant to the same;


"(b) To assume primary jurisdiction in the collection of samples of health
products;

"(c) To analyze and inspect health products in connection with the
implementation of this Act;

"(d) To establish analytical data to serve as basis for the preparation of
health products standards, and to recommend standards of identity, purity,
safety, efficacy, quality and fill of container;

"(e) To issue certificates of compliance with technical requirements to serve
as basis for the issuance of appropriate authorization and spot-check for
compliance with regulations regarding operation of manufacturers,
importers, exporters, distributors, wholesalers, drug outlets, and other
establishments and facilities of health products, as determined by the FDA;

XXX

"(h) To conduct appropriate tests on all applicable health products prior to
the issuance of appropriate authorizations to ensure safety, efficacy, purity,
and quality;

"(i) To require all manufacturers, traders, distributors, importers, exporters,
wholesalers, retailers, consumers, and non-consumer users of health
products to report to the FDA any incident that reasonably indicates that said
product has caused or contributed to the death, serious illness or serious
injury to a consumer, a patient, or any person;

"(j) To issue cease and desist orders motu propio or upon verified complaint
for health produts, whether or not registered with the FDA Provided, That
for registered health products, the cease and desist order is valid for thirty
(30) days and may be extended for sixty (60) days only after due process has
been observed;

"(k) After due process, to order the ban, recall, and/or withdrawal of any
health product found to have caused the death, serious illness or serious
injury to a consumer or patient, or is found to be imminently injurious,
unsafe, dangerous, or grossly deceptive, and to require all concerned to
implement the risk management plan which is a requirement for the issuance
of the appropriate authorization;


9711,

"()) To strengthen the post market surveillance system in monitoring health
products as defined in this Act and incidents of adverse events involving
such products;

"(m) To develop and issue standards and appropriate authorizations that
would cover establishments, facilities and health products;

"(n) To conduct, supervise, monitor and audit research studies on health and
safety issues of health products undertaken by entities duly approved by the
FDA;

"(o) To prescribe standards, guidelines, and regulations with respect to
information, advertisements and other marketing instruments and promotion,
sponsorship, and other marketing activities about the health products as
covered in this Act;

"(p) To maintain bonded warehouses and/or establish the same, whenever
necessary or appropriate, as determined by the director-general for
confiscated goods in strategic areas of the country especially at major ports
of entry; and

"(q) To exercise such other powers and perform such other functions as may
be necessary to carry out its duties and responsibilities under this Act."

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

"The FDA shall review its staffing pattern and position titles, and may hire
the required personnel to carry out its mandate under this Act, subject to
existing civil service laws and regulations."

Section 3. — The budgetary requirement necessary for the operation of the

EDA shall be included in the annual General Appropriations Act (GAA).

Section 4. - All laws, acts, decrees, executive orders, proclamations, rules

and regulations, or part or parts thereof which are inconsistent with any of the
provisions of this Act are hereby amended, modified or repealed.

Section 5. — If any part or provision of this Act is held unconstitutional or

invalid, other parts or provisions thereof which are not affected shall continue to
remain in full force and effect.


Section 6. This Act shall take effect fifteen (15) days following
completion of its publication in at least two (2) newspapers of general circulation.

Approved.