SEVENTEENTH CONGRESS OF THE) 
REPUBLIC OF THE PHILIPPINES 
) 
Second Regular Session 
)
j - t  I;*
S E N  AT 
S.B. No.
\h i
’17 
DEC- 7  
"r j 5 1
Introduced by Senator JOSEPH VICTOR G. EJERCITO
AN ACT
INSTITUTING 
FOOD 
AND 
DRUG 
ADMINISTRATION 
AS 
AN 
INDEPENDENT AGENCY AND SEPARATE FROM THE DEPARTMENT 
OF HEALTH, AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 
3720, AS AMENDED BY REPUBLIC ACT NO. 9711, AND FOR OTHER 
PURPOSE
EXPLANATORY NOTE
Republic Act No. 9711, othemise known as the Food and Drug 
Administration (FDA) Act of 2009 stales that it is a declared policy of the State 
adopt, support, establish, institutionalize, improve and maintain structures, 
processes, mechanisms and initiatives that are aimed, directed and designed to: 
(a) protect and promote the right to health of the Filipino people; and (b) help 
establish and maintain an effective health products regulatory system and 
undertake appropriate health manpower development and 
research, 
responsive to the country's health needs and problems.
Tlie FDA Act of 2009 expressly provides that FDA shall be under the 
Office of the Secretary of Health. However, the current organizational structure 
of the Department of Health having FDA as one of its attached agencies breeds 
potential conflict that can compromise the neutrality of FDA.
To further enhance FDA's regulatoiy capacity and strengthen its 
capability with regard to the inspection, licensing and monitoring of 
establishments, and the registration and monitoring of healtli product, it is 
rational to institute FDA as an independent and autonomous body. As such


proposed bill seeks to separate FDA from the Department of Health and instead 
attached it to the Office of the President for administrative purposes only.
In view of the foregoing, the passage of this measure is earnestly sought.
JOSEPH VICTOR G. EJERCITO


SEVENTEENTH CONGRESS OF THE) 
REPUBLIC OF THE PHILIPPINES 
) 
Second Regular Session 
)
’ \\
S E N A T E o 
S.B. No. 
1631
■|7 
OrC -7 
n:n-.51
Introduced by Senator JOSEPH VICTOR G. EJERCITO
AN ACT
INSTITUTING 
FOOD 
AND 
DRUG 
ADMINISTRATION 
AS 
AN 
INDEPENDENT AGENCY AND SEPARATE FROM THE DEPARTMENT 
OF HEALTH, AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 
3720, AS AMENDED BY REPUBLIC ACT NO. 9711, AND FOR OTHER 
PURPOSE
Ik’ it ciinctcii by the Scnntc and House of Representatives of the Philippines in Congress 
assenihled.
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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 
AUTONOMOUS 
FROM 
THE 
DEPARTMENT OF HEALTH. IT SHALL BE ATTACHED TO 
THE OFFICE OF THE PRESIDENT FOR ADMINISTRATIVE 
PURPOSES ONLY. IT SHALL EXERCISE THE FOLLOWING 
FUNCTIONS, POWERS AND DUTIES [Said Administration 
shall be under the Office of the Secretary and 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;
XXX
XXX
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:


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"(a) The FDA shall be headed by a director-general, with the rank 
of [undersecretary,] A DEPARTMENT SECRETARY WHO 
SHALL BE A MEMBER OF THE CABINET. THE DIRECTOR- 
GENERAL SHALL BE APPOINTED BY THE PRESIDENT 
SUBJECT TO CONFIRMATION BY THE COMMISSION ON 
APPOINTMENTS. THE DIRECTOR-GENERAL [who] shall be 
tasked, among others, to determine the needed personnel and to 
appoint personnel, below the assistant director level in 
[coordination with the Secretary of Health] ACCORDANNCE 
WITH THE CIVIL SERVICE LAW;"
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"(h) Each center and field office shall be headed by a director who 
shall be assi.sted by an assistant director. These directors shall be 
appointed by the [Secretary 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:
"Tlie FDA shall review its staffing pattern 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 liereby amended to read as follows:
SEC. 32. 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, is hereby further amended to read as follows:
"SEC. 34. Fees mui Other Income. -
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"(a) Upon the sole approval of the [Secretary] PRESIDENT, the 
authorization and other fees shall annually be determined and


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reviewed by the FDA and any proposed increase shall be 
published in two (2) leading newspapers of general circulation.
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"(c) Tlie Director-General of the FDA, upon approval of the 
[Secretaiy] PRESIDENT, shall be authorized to promulgate rules 
and regulations governing the collection of the 'other related 
regulatoiy fees'. Upon approval of the [Secretary] PRESIDENT, 
these fees shall likewise be reviewed periodically and any 
proposed increase shall be published in two (2) leading 
newspapers of general circulation."
SEC. 6. Section 18 of Republic Act No. 9711 is hereby amended to read as
follows:
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Tlie 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 Secretaiy of Budget and 
Management and the Congressional Oversight Committee, 
created under Section 2v3 of this Act, a report on how the funds 
were utilized, including its accomplishments.
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SEC. 7. Section 35 of Republic Act No. 3720, as amended by Section 20 of 
Republic Act No. 9711, is hereby furtlier amended to read as follows:
SEC. 35. XXX
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"Tlie testing laboratories may be increased by tlie director-general, 
upon approval of the [Secretary] PRESIDENT. Moreover, the 
director-general, upt)ii approval of the [Secretary] PRESIDENT, 
may call upon other government and private testing laboratories 
to conduct testing, calibration, assay and examination of samples 
of healtli products: Pivviikd, That the private testing laboratories


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are accredited by the Philippine Accreditation Office (PAO) of the 
Department of Trade and industiy (DTI) and the FDA."
SEC. 8. Section 35 of Republic Act No. 3720, as amended by Section 20 of 
Republic Act No. 9711, is hereby further amended to read as follows:
"SEC. 37. The FDA, with the approval of the [Secretary] 
PRESIDENT, shall create organizational units which are deemed 
necessary 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 mles and regulations."
SEC. 9. Scpmabilif]/ Clause. - If any provision of this Act is held invalid or 
unconstitutional, other provisions not affected thereby shall continue to be in 
full force and effect.
SEC. 10. Rcpcaliug Clause. - All laws, decrees, executive orders or parts thereof 
inconsistent with the provisions of this Act are hereby repealed, amended or 
modified accordingly.
SEC. 11. Effectivit}/ Clause. - Tliis Act shall take effect fifteen (15) days after its 
complete publication in the Official Gazelle or in a national newspaper of general 
circulation.
Approved,