Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

Seventeenth Congress.
First Regular Session

HOUSE BILL NO,__ 3971 |

Introduced by Honorable Doy C. Leachon

EXPLANATORY NOTE

This bill seeks to separate the Food and Drug Administration (FDA) from
the Department of Health (DOH), amending for the purpose Republic Act (RA)
No. 3720, otherwise known as the “Food, Drug and Cosmetic Act,” as amended
by RA 9711, otherwise known as the “Food and Drug Administration Act of
2009” to become an independent and autonomous office attached to the Office
of the President of the Philippines.

It is the policy of the State to promote and protect the right to health of
the Filipino people. In pursuit of this policy, Republic Act No. 3720, otherwise
known as the “Food, Drug and Cosmetic Act” was passed in 1963. It aims to
ensure the supply of safe, pure and quality food, drugs, cosmetics and other
health products to the public, Thus, in order to carry out effectively the policies
and objectives of this Act, the Food and Drug Administration (FDA) was
created.

Under Executive Order No. 851 issued in 1982, FDA was abolished and
replaced by the Bureau of Food and Drugs (BFAD). It absorbed all the
functions of the former and expanded its operations. State of the art analytical
instruments and modern experimental animal laboratory were acquired to
strengthen its capabilities in research, analysis and inspection of food and health
products.

In 2009, Republic Act No. 9711, otherwise known as the “Food and
Drug Administration (FDA) Act of 2009” was passed to strengthen and
rationalize the regulatory capacity of the Bureau of Food and Drug by
establishing adequate testing laboratories and field offices and upgrading its
human resources complement, giving authority to retain its income. The law
renamed BFAD to Food and Drug Administration (FDA) and amended certain
sections of RA 3720. RA 9711 also strengthened the law enforcement

6


capability of the agency by integrating the regional operatives under a single
directorate and establishing a law enforcement unit that has functions, powers
and responsibilities similar to the National Bureau of Investigation and the
Philippine National Police under every regional office.

With these laws and other issuances set to enhance the capability of the
FDA to perform its main goal to ensure the health and safety of food and drugs
made available to the public, the effectiveness of the FDA is still being
hampered by bureaucracy, meddling politicians and confusing budgetary lines.

The PDA is currently part of the Department of Health. Making it an
independent and autonomous office, separate from DOH, would be a step in the
right direction on public health. A single, independent and autonomous food
and drugs safety agency will provide a focused and centralized leadership. It
will be the primary voice on food and drugs, on safety standards and on
compliance with those standards. It will establish clear lines of responsibility
and accountability that will enhance both prevention of and responses to
outbreaks of food borne illnesses. Finally, an independent FDA will ensure the
flow of safe and healthy food, drugs, cosmetics, medical devices and household
materials in the country.

The enactment of this bill will ensure a mote efficient FDA in the
discharge of its role and responsibilities. EDA will be the sole lead agency in
the implementation of its mandate to administer and enforce the laws pertaining
to safety and quality of food, drugs, health products, cosmetics and household
products.

In view of the foregoing, immediate approval of this bill is earnestly
sought.

DOY Gg. LEACHON


15

16

7

18

19

20

21

22

23

Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

Seventeenth Congress
First Regular Session

HOUSE BILL NO. _ 3971

Introduced by Honorable Doy C. Leachon

AN ACT
SEPARATING THE FOOD AND DRUG ADMINISTRATION FROM
THE DEPARTMENT OF HEALTH, AMENDING FOR THE PURPOSE
REPUBLIC ACT NO, 3720, OTHERWISE KNOWN AS THE “FOOD,
DRUG AND COSMETIC ACT,” AS AMENDED BY REPUBLIC ACT NO.
9711, OTHERWISE KNOWN AS THE “FOOD AND DRUG
ADMINISTRATION ACT OF 2009”

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

SECTION 1, Section 4 of Republic Act No. 3720, as amended by
Section 5 of Republic Act No. 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) [in the Department of Health (DOH)].

THE FDA SHALL BE INDEPENDENT AND SEPARATE

FROM THE DEPARTMENT OF HEALTH (DOH) AND

ATTACHED TO THE OFFICE OF THE PRESIDENT FOR

ADMINISTRATIVE PURPOSES ONLY, [Said Administration

shall be under the Office of the Secretary and shall have the
]

following functions, powers and


15

16

7

18

19

20

21

22

23

24

25

26

THE FDA SHALL EXERCISE THE FOLLOWING

FUNCTIONS, POWERS AND DUTIES:

a) To administer the effective implementation of this
Act, [and of the same] ITS IMPLEMENTING RULES and

regulations AND OTHER ISSUANC!
PROMULGATED pursuant to [the same] THIS ACT;

XXX XXX XXX.

SEC. 2. Section 6 of Republic Act No. 3720, as amended by Section 7 of

Republic Act No. 8711, is hereby further amended to read as follows:

“SEC. 6. a) The FDA shall be headed by a director-general,
with the rank of [undersecretary] A DEPARTMENT
SECRETARY, who shall be A REGULAR MEMBER OF THE

CABINET. THE DIRECTOR-GENERAL SHALL

APPOINTED BY THE PRESIDENT SUBJECT TO

CONFIRMATION BY THE COMMISSION

APPOINTMENTS. THE DIRECTOR-GENERAL SHALL BE

tasked, among others, to determine the needed personnel and to

appoint personnel below the assistant director level

[coordination] ACCORDANCE with the [Secretary of Health]

CIVIL SERVICE LAWS, RULES AND REGULATIONS;

b) xxx XXX XXX

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 [Secretary of Health|

DIRECTOR-GENERAL”
i) Xxx XXX XXX."
SEC
Republic Act No, 9711 is hereby further amended to read as follows:

[issued]

. 3. Section 7 of Republic Act No. 3720 as amended by Section 8 of


20

a

22

23

24

25

26

7

28

“SEC. 7. The FDA shall review its staffing pattem and
position titles subject to the approval of the [Secretary of Health]
PRESIDENT.”

SEC. 4, 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. PURSUANT TO EXISTING RULES AND
REGULATIONS GOVERNING APPEALS TO THE OFFICE OF
THE PRESIDENT, the orders, rulings or decisions of the FDA
shall be appealable to the [Secretary 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. 5. Section 34 of Republic Act No. 3720, as amended by Section 17
of Republic Act No. 9711, to read as follows:

“SEC, 34. Fees and Other Income. —

a) Upon the sole approval of the [Secretary]
PRESIDENT, the authorization and other fees shall annually be
determined and reviewed by the FDA and any proposed increase
shall be published in two (2) leading newspapers of general
circulation.

b) xxx XXX XXX

c) The director-general of the FDA upon approval of the
[Secretary] PRESIDENT, shall be authorized to promulgate rules
and regulations governing the collection of the other related
regulatory fees. Upon approval of the [Secretary] PRESIDENT,

these fees shall likewise be reviewed periodically and any


1 proposed increase shall be published in two (2) leading newspapers

2 of general circulation.”

3 SEC. 6. Section 18 of Republic Act No. 9711 is hereby amended to read
4 as follows:

5 “SEC. 18, xxx XXX XXX

6 XXX XXX XXX

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

19 XXX XXX aK

20 SEC. 7, Section 35 of Republic Act No. 3720, as amended by Section 20
21 of Republic Act No. 9711, is hereby amended to read as follows:

22 “SEC. 35. xxx XXX XXX

23 The testing laboratories may be increased by the director-
2A general, upon approval of the [Secretary] PRESIDENT.
25 Moreover, the director-general, upon approval of the [Secretary]
26 PRESIDENT, may call upon other government and private testing
27 laboratories to conduct testing, calibration, assay and examination
28 of samples of health products: Provided, That the private testing


laboratories are accredited by the Philippine Accreditation Office

(PAO) of the Department of Trade and Industry (DTI) and the

[DOH] FDA.”

SEC. 8. Section 37 of Republic Act No, 3720, as amended by Section 20
of Republic Act No, 9711 is hereby further amended to read as follows:

C. 37. The FDA, with the approval of the [Secretary]
PRESIDENT, shall create organizational units which are deemed

‘ary to address emerging concerns and to be abreast with
internationally acceptable standards. There shall be created
additional plantilla positions to augment the human resource
complement of the FDA, subject to existing rules and regulations.”

SEC. 9. The FDA shall, in consultation with the DOH, promulgate the
implementing rules and regulations of this Act within one hundred twenty (120)
days after the passage of this Act.

SEC. 10. This Act shall take effect fifteen (15) days after its publication
in the Official Gazette or in a newspaper of general circulation.

Approved,